Timing of Transcranial Direct Current Stimulation (tDCS) Combined With Speech and Language Therapy (SLT)
Primary Purpose
Aphasia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Offline tDCS-before therapy
Sham tDCS
Offline tDCS-after therapy
Online tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring Aphasia, tDCS, Script training, Functional language, Naming
Eligibility Criteria
Inclusion Criteria:
- Men or women with diagnosis of fluent or non-fluent aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by a MRI or CT scan
- Aphasia quotient on the WAB of 35-85
- At least 6 months post onset of aphasia (this is beyond the stage of spontaneous recovery)
- 18- 80 years of age
- Premorbidly fluent in English
- Premorbidly right-hand dominant per the Edinburg Handedness Inventory
- Visual acuity of 20/40 corrected
- Auditory acuity no worse than 30 dB HL on pure tone testing, aided in the better ear.
- Education greater than 12th grade
Exclusion Criteria:
- Any other neurological condition (other than cerebral vascular disease) that could impact language and cognition such as Alzheimer's disease, Parkinson's disease, primary progressive aphasia, and traumatic brain injury
- Active substance use
- Individuals with epilepsy
Sites / Locations
- Shirley Ryan AbilityLabRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Offline tDCS-before therapy
Offline tDCS-after therapy
Online tDCS
Sham tDCS
Arm Description
Participants will receive 20 minutes of tDCS prior to the 40 minute speech-language therapy session.
Participants will receive 20 minutes of tDCS after the 40 minute speech-language therapy session.
tDCS will be applied at the beginning of the 40 minute speech-language therapy session and will last for 20 minutes.
Sham tDCS will be applied at the beginning of the 40 minute speech-language therapy session.
Outcomes
Primary Outcome Measures
Change in trained conversational script.
Changes in accuracy and rate of production on a trained conversational script from pre to post-treatment.
Secondary Outcome Measures
Change in untrained conversational script
Changes in accuracy and rate of production on an untrained conversational script from pre to post-treatment.
Change in the Aphasia Quotient (AQ) of Western Aphasia Battery-Revised (WAB-R)
Changes in WAB-R AQ from pre and post treatment.
Maintenance of trained conversational script
Accuracy and rate of production of trained conversational script at 4 weeks post-treatment
Maintenance of trained conversational script
Accuracy and rate of production of trained conversational script at 8 weeks post-treatment
Full Information
NCT ID
NCT03773406
First Posted
December 10, 2018
Last Updated
July 24, 2022
Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
1. Study Identification
Unique Protocol Identification Number
NCT03773406
Brief Title
Timing of Transcranial Direct Current Stimulation (tDCS) Combined With Speech and Language Therapy (SLT)
Official Title
Timing of Transcranial Direct Current Stimulation (tDCS) Combined With Speech and Language Therapy (SLT): An Intervention Development Study for Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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.
Yes
5. Study Description
Brief Summary
Aphasia is an acquired (typically left-hemisphere) multi-modality disturbance of language that impacts around 2 million people in the USA. Aphasia impacts language production and comprehension as well as reading and writing. The ramifications of aphasia extend beyond language impairment to negatively impacting a person's social, vocational, and recreational activities. Currently, the most effective way to treat aphasia is with speech-language therapy (SLT). However, even if SLT is intensive, persons with aphasia are left with residual language delays. Recent research suggests that pairing SLT with transcranial direct current stimulation (tDCS) a non-invasive, safe, low-cost form of brain stimulation may aid language recovery in persons with aphasia. However, results from tDCS studies are inconclusive. The success of tDCS in combination with SLT could depend on the timing of tDCS since tDCS-induced effects depend on the neuronal state of the brain-networks at the time of the stimulation. In this study, the differential impact of tDCS before behavioral SLT (offline-before therapy), tDCS after SLT (offline-after therapy), and tDCS concurrently with SLT (online) on functional language recovery in persons with aphasia will be investigated. Sham tDCS (i.e., SLT alone) as a control group will also be included in the study. The investigators hypothesize that both offline and online tDCS will improve language functioning than sham tDCS.
Detailed Description
tDCS Implementation:
2mA of direct current for 20 minutes will be delivered using a constant current stimulator via two electrodes in saline soaked sponges. To stimulate the left angular gyrus, a cathodal electrode inside a saline soaked sponge (5 x 3cm) will be placed over the CP5 according to the 10-20 international system for EEG electrode placement. The electrodes will be secured in position by a custom-built EEG cap that will be marked with the location for angular gyrus. The investigators will then confirm that the cathodal electrode is over the left angular through the use of neuronavigation. The "return" anode electrode will be placed in a saline soaked sponge (5 x 5cm) on the center of the supraorbital region.
At the beginning of the tDCS, current will slowly ram-up during the first few seconds until it reaches 2mA. The ramp-up process will acclimate the participants to tDCS-induced sensations (e.g., itching). At the end of the tDCS sessions, current will slowly ramp down in the last few seconds to 0mA. The total duration of the 2mA current will be maintained for 20 minutes. For sham stimulation, the investigators will place the electrodes in the same location as the real tDCS groups with stimulation ending after few seconds. The brief stimulation will produce tDCS-induced sensations so that participants will not be aware when the tDCS stopped delivering direct current
Speech-Language Treatment:
Standard-of-care treatment - script training will be used to provide SLT to our participants. The treatment will be delivered via a computer program, Aphasia Scripts ®, whereby a virtual therapist interactively guides the participants through treatment steps. Scripts will be five to ten sentences and developed from common templates about topics relevant to daily life (e.g., asking questions at the grocery store, ordering in a restaurant). The advantage of using a computer program instead of a human therapist is that it removes extraneous variables associated with human therapists (e.g., different levels of encouragement) and this, together with the use of script templates, ensures treatment fidelity across participants.
Duration of an individual subject's participation in the study:
Subjects will be requested to come for baseline sessions (3 to 4 hours) before the actual experiment. The baseline assessments may be done over two visits. In the baseline session the subjects' aphasia severity will be assessed. The participants will also perform baseline tasks of language and cognition in this session. Subjects will then participate in 3 weeks of tDCS and SLT (i.e., 15 sessions). The sessions will consist of 40 minutes of SLT and 20 minutes of tDCS. Subjects will be asked to return for an assessment immediately following the end of treatment and for follow-up testing after 4 and 8 weeks. Therefore, total number of visits will be 19-23 sessions (depending on how many visits are needed for the assessments) over a period of three months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
Aphasia, tDCS, Script training, Functional language, Naming
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Offline tDCS-before therapy
Arm Type
Active Comparator
Arm Description
Participants will receive 20 minutes of tDCS prior to the 40 minute speech-language therapy session.
Arm Title
Offline tDCS-after therapy
Arm Type
Active Comparator
Arm Description
Participants will receive 20 minutes of tDCS after the 40 minute speech-language therapy session.
Arm Title
Online tDCS
Arm Type
Active Comparator
Arm Description
tDCS will be applied at the beginning of the 40 minute speech-language therapy session and will last for 20 minutes.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham tDCS will be applied at the beginning of the 40 minute speech-language therapy session.
Intervention Type
Device
Intervention Name(s)
Offline tDCS-before therapy
Intervention Description
Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
Stimulation will be given for a total 30 seconds (including ramp-up and ramp-down of current) and then the tDCS device will be turned off. The brief stimulation will produce tDCS-induced sensation so that participants will not be aware when the tDCS was turned off .We will use standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
Intervention Type
Device
Intervention Name(s)
Offline tDCS-after therapy
Intervention Description
Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
Intervention Type
Device
Intervention Name(s)
Online tDCS
Intervention Description
Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
Primary Outcome Measure Information:
Title
Change in trained conversational script.
Description
Changes in accuracy and rate of production on a trained conversational script from pre to post-treatment.
Time Frame
3 weeks.
Secondary Outcome Measure Information:
Title
Change in untrained conversational script
Description
Changes in accuracy and rate of production on an untrained conversational script from pre to post-treatment.
Time Frame
3 weeks
Title
Change in the Aphasia Quotient (AQ) of Western Aphasia Battery-Revised (WAB-R)
Description
Changes in WAB-R AQ from pre and post treatment.
Time Frame
3 weeks
Title
Maintenance of trained conversational script
Description
Accuracy and rate of production of trained conversational script at 4 weeks post-treatment
Time Frame
7 weeks
Title
Maintenance of trained conversational script
Description
Accuracy and rate of production of trained conversational script at 8 weeks post-treatment
Time Frame
11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women with diagnosis of fluent or non-fluent aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by a MRI or CT scan
Aphasia quotient on the WAB of 35-85
At least 6 months post onset of aphasia (this is beyond the stage of spontaneous recovery)
18- 80 years of age
Premorbidly fluent in English
Premorbidly right-hand dominant per the Edinburg Handedness Inventory
Visual acuity of 20/40 corrected
Auditory acuity no worse than 30 dB HL on pure tone testing, aided in the better ear.
Education greater than 12th grade
Exclusion Criteria:
Any other neurological condition (other than cerebral vascular disease) that could impact language and cognition such as Alzheimer's disease, Parkinson's disease, primary progressive aphasia, and traumatic brain injury
Active substance use
Individuals with epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leora Cherney, PhD
Phone
312-238-1117
Email
lcherney@sralab.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sameer Ashaie, PhD
Phone
312-238-6163
Email
sameer.ashaie@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leora Cherney, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leora Cherney, PhD
Phone
312-238-1117
Email
lcherney@sralab.org
First Name & Middle Initial & Last Name & Degree
Sameer Ashaie, PhD
Phone
312-238-6163
Email
sameer.ashaie@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Leora Cherney, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35978374
Citation
Ashaie SA, Engel S, Cherney LR. Timing of transcranial direct current stimulation (tDCS) combined with speech and language therapy (SLT) for aphasia: study protocol for a randomized controlled trial. Trials. 2022 Aug 17;23(1):668. doi: 10.1186/s13063-022-06627-9.
Results Reference
derived
Learn more about this trial
Timing of Transcranial Direct Current Stimulation (tDCS) Combined With Speech and Language Therapy (SLT)
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