Combining tDCS and CILT in Non-fluent Aphasia
Primary Purpose
Aphasia, Non-fluent Aphasia, Stroke
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring transcranial direct current stimulation (tDCS), non-invasive brain stimulation (NIBS), aphasia, constraint-induced language therapy (CILT)
Eligibility Criteria
Inclusion Criteria:
- over the age of 18 years
- history of stroke
- diagnosed with non-fluent aphasia.
- be able to independently understand simple directions,
- use some speech to communicate,
- have access to reliable transportation (including taxi and/or other transportation services),
- fluent in English.
Exclusion Criteria:
- Pregnancy,
- history of seizures,
- any metal implants in the body (excluding dental fillings),
- history of migraines,
- psoriasis or eczema affecting the scalp,
- history of a head injury such as a concussion
- diagnosis of a mental health or neurological condition/disease.
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Real tDCS
Sham tDCS
Arm Description
the participant receives real tDCS to the right cerebellum during behavioral intervention (CILT)
the participant receives sham tDCS to the right cerebellum during behavioral intervention (CILT)
Outcomes
Primary Outcome Measures
Discourse Analysis: Picture Description
Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance
Discourse Analysis: Picture Description
Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance
Discourse Analysis: Picture Description
Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance
Discourse Analysis: Picture Description
Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance
Discourse Analysis: Story Retell
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance
Discourse Analysis: Story Retell
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance
Discourse Analysis: Story Retell
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance
Discourse Analysis: Story Retell
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance
Discourse Analysis: Procedural
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance
Discourse Analysis: Procedural
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance
Discourse Analysis: Procedural
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance
Discourse Analysis: Procedural
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance
Verbal fluency: Semantic
Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Verbal fluency: Semantic
Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Verbal fluency: Semantic
Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Verbal fluency: Semantic
Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Verbal fluency: Phonemic
Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Verbal fluency: Phonemic
Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Verbal fluency: Phonemic
Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Verbal fluency: Phonemic
Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Secondary Outcome Measures
Working Memory
Participant will complete the n-back test. The score represents the raw score, total items minus errors. The higher the score the better
Working Memory
Participant will complete the n-back test. The score represents the raw score, total items minus errors. The higher the score the better
Working Memory
Participant will complete the n-back test. The score represents the raw score, total items minus errors. The higher the score the better
Working Memory
Participant will complete the n-back test. The score represents the raw score, total items minus errors. The higher the score the better
EEG: Power spectral analysis
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better. Measures from right and left fronto-temporal regions will be calculated for analysis.
EEG: Power spectral analysis
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better. Measures from right and left fronto-temporal regions will be calculated for analysis.
EEG: Power spectral analysis
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better.Measures from right and left fronto-temporal regions will be calculated for analysis.
EEG: Power spectral analysis
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better. Measures from right and left fronto-temporal regions will be calculated for analysis.
EEG: Coherence
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Coherence coefficient will be calculated in the right and left fronto-temporal regions. Higher correlation is associated with more functional connectivity.
EEG: Coherence
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Coherence coefficient will be calculated in the right and left fronto-temporal regions. Higher correlation is associated with more functional connectivity.
EEG: Coherence
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Coherence coefficient will be calculated in the right and left fronto-temporal regions. Higher correlation is associated with more functional connectivity.
EEG: Coherence
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Coherence coefficient will be calculated in the right and left fronto-temporal regions. Higher correlation is associated with more functional connectivity.
Stroke Aphasia Quality of Life (SA-QOL)
Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better
Stroke Aphasia Quality of Life (SA-QOL)
Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better
Stroke Aphasia Quality of Life (SA-QOL)
Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better
Stroke Aphasia Quality of Life (SA-QOL)
Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05561400
Brief Title
Combining tDCS and CILT in Non-fluent Aphasia
Official Title
Combining Cerebellar tDCS and Constraint-induced Language Therapy in Non-fluent Aphasia: a Novel Approach to Target Discourse
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The long-term goal of this work is to determine if combining a highly intensive, task-specific behavioral language intervention with modulation of the efferent cerebellar-cortical pathway using transcranial direct current stimulation (tDCS) has a positive influence on discourse, verbal fluency and working memory in individuals with non-fluent aphasia after stroke. And if these changes can be related to neuroplastic change in the cerebellar cortical pathway indirectly measured through neurophysiologic changes using spectral electroencephalogram (EEG). The initial phase includes the proposed pilot study data from which will be used to inform a larger clinical trial. The primary aims of this pilot are to 1) determine the effect of combining cerebellar tDCS with constraint-induced language therapy (CILT) on language as measured by a verbal fluency task and discourse task in a small population and 2) identify the tolerance of the intervention and barriers to participation measured by the adverse events questionnaire that will inform the methodology of a larger study. The secondary aims include estimating the size of the treatment effect on 1) delta percentage in F3, F7 and Fp1 compared to F4, F8, and Fp2 using resting state EEG spectral analysis and coherence, 2) working memory as measured by the score on the n-back test and 3) quality of life as measured by the Stroke Aphasia Quality of Life survey tool. The secondary aims will be used to determine the utility of these measures in a larger clinical trial.
This is a prospective, crossover study, sham-controlled intervention study with two intervention conditions delivered across 6 intervention sessions (3x/week for two weeks) with a 4-week washout in between. Conditions include: 1) sham cerebellar tDCS and 2) real cerebellar tDCS delivered at 2mA across 20 minutes. Each of these will be delivered during CILT intervention with a licensed, certified speech-language pathologist trained in CILT. Once tDCS stimulation has ended, CILT will continue to be delivered for an additional 25 minutes. Assessments of discourse, verbal fluency, working memory and EEG spectral analysis will be conducted at four timepoints, before and after each intervention phase.
Detailed Description
This is a prospective sham-controlled, cross-over design. Eligible participants must be over the age of 18 years, be > least 6 months post unilateral cortical stroke and diagnosed with mild to moderate non-fluent aphasia. Additional inclusion/exclusionary criteria have been specified in and approved by the IRB. Six to seven participants are expected to be recruited and screened, with the goal to enroll and complete the study with four individuals who will be randomly assigned to receive either sham or real condition first. The two intervention conditions include: 1) andodal tDCS (2mA) to the right posterior-lateral cerebellum and 2) sham tDCS to the right posterior-lateral cerebellum. The participants will receive 20 minutes of tDCS (sham or real) during CILT followed by an additional 25 minutes of CILT alone. Each condition will be administered 3 days per week for two weeks for a total of 6 intervention sessions with a 4-week washout period between.
For tDCS (TCT-Research Version tDCS Stimulator, Hong Kong), two 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting the posterior lateral cerebellum and the cathode will be placed on the right shoulder. The electrode placement will be the same across both conditions. The CILT behavioral intervention will be led by a certified, licensed speech-language pathologist and a graduate student researcher and will follow the guidelines of CILT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Non-fluent Aphasia, Stroke, Brain Injuries
Keywords
transcranial direct current stimulation (tDCS), non-invasive brain stimulation (NIBS), aphasia, constraint-induced language therapy (CILT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Sham controlled blinded crossover design
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real tDCS
Arm Type
Active Comparator
Arm Description
the participant receives real tDCS to the right cerebellum during behavioral intervention (CILT)
Arm Title
Sham tDCS
Arm Type
Placebo Comparator
Arm Description
the participant receives sham tDCS to the right cerebellum during behavioral intervention (CILT)
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
5x5 saline-soaked sponge electrodes will be used with the cathode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the anode will be placed on the right shoulder. The electrode placement will be the same across both conditions.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
sham tDCS to the right cerebellum
Primary Outcome Measure Information:
Title
Discourse Analysis: Picture Description
Description
Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance
Time Frame
Initial Assessment/Baseline: Visit 2
Title
Discourse Analysis: Picture Description
Description
Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance
Time Frame
Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Title
Discourse Analysis: Picture Description
Description
Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance
Time Frame
Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Title
Discourse Analysis: Picture Description
Description
Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance
Time Frame
Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Title
Discourse Analysis: Story Retell
Description
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance
Time Frame
Initial Assessment/Baseline: Visit 2
Title
Discourse Analysis: Story Retell
Description
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance
Time Frame
Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Title
Discourse Analysis: Story Retell
Description
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance
Time Frame
Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Title
Discourse Analysis: Story Retell
Description
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance
Time Frame
Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Title
Discourse Analysis: Procedural
Description
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance
Time Frame
Initial Assessment/Baseline: Visit 2
Title
Discourse Analysis: Procedural
Description
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance
Time Frame
Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Title
Discourse Analysis: Procedural
Description
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance
Time Frame
Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Title
Discourse Analysis: Procedural
Description
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance
Time Frame
Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Title
Verbal fluency: Semantic
Description
Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Time Frame
Initial Assessment/Baseline: Visit 2
Title
Verbal fluency: Semantic
Description
Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Time Frame
Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Title
Verbal fluency: Semantic
Description
Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Time Frame
Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Title
Verbal fluency: Semantic
Description
Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Time Frame
Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Title
Verbal fluency: Phonemic
Description
Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Time Frame
Initial Assessment/Baseline: Visit 2
Title
Verbal fluency: Phonemic
Description
Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Time Frame
Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Title
Verbal fluency: Phonemic
Description
Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Time Frame
Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Title
Verbal fluency: Phonemic
Description
Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17
Time Frame
Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Secondary Outcome Measure Information:
Title
Working Memory
Description
Participant will complete the n-back test. The score represents the raw score, total items minus errors. The higher the score the better
Time Frame
Initial Assessment/Baseline: Visit 2
Title
Working Memory
Description
Participant will complete the n-back test. The score represents the raw score, total items minus errors. The higher the score the better
Time Frame
Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Title
Working Memory
Description
Participant will complete the n-back test. The score represents the raw score, total items minus errors. The higher the score the better
Time Frame
Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Title
Working Memory
Description
Participant will complete the n-back test. The score represents the raw score, total items minus errors. The higher the score the better
Time Frame
Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Title
EEG: Power spectral analysis
Description
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better. Measures from right and left fronto-temporal regions will be calculated for analysis.
Time Frame
Initial Assessment/Baseline: Visit 2
Title
EEG: Power spectral analysis
Description
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better. Measures from right and left fronto-temporal regions will be calculated for analysis.
Time Frame
Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Title
EEG: Power spectral analysis
Description
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better.Measures from right and left fronto-temporal regions will be calculated for analysis.
Time Frame
Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Title
EEG: Power spectral analysis
Description
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better. Measures from right and left fronto-temporal regions will be calculated for analysis.
Time Frame
Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Title
EEG: Coherence
Description
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Coherence coefficient will be calculated in the right and left fronto-temporal regions. Higher correlation is associated with more functional connectivity.
Time Frame
Initial Assessment/Baseline: Visit 2
Title
EEG: Coherence
Description
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Coherence coefficient will be calculated in the right and left fronto-temporal regions. Higher correlation is associated with more functional connectivity.
Time Frame
Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Title
EEG: Coherence
Description
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Coherence coefficient will be calculated in the right and left fronto-temporal regions. Higher correlation is associated with more functional connectivity.
Time Frame
Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Title
EEG: Coherence
Description
Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Coherence coefficient will be calculated in the right and left fronto-temporal regions. Higher correlation is associated with more functional connectivity.
Time Frame
Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Title
Stroke Aphasia Quality of Life (SA-QOL)
Description
Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better
Time Frame
Initial Assessment/Baseline: Visit 2
Title
Stroke Aphasia Quality of Life (SA-QOL)
Description
Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better
Time Frame
Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Title
Stroke Aphasia Quality of Life (SA-QOL)
Description
Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better
Time Frame
Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Title
Stroke Aphasia Quality of Life (SA-QOL)
Description
Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better
Time Frame
Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
over the age of 18 years
history of stroke
diagnosed with non-fluent aphasia.
be able to independently understand simple directions,
use some speech to communicate,
have access to reliable transportation (including taxi and/or other transportation services),
fluent in English.
Exclusion Criteria:
Pregnancy,
history of seizures,
any metal implants in the body (excluding dental fillings),
history of migraines,
psoriasis or eczema affecting the scalp,
history of a head injury such as a concussion
diagnosis of a mental health or neurological condition/disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharyl A Samargia-Grivette, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55812
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combining tDCS and CILT in Non-fluent Aphasia
We'll reach out to this number within 24 hrs