Back to resultsEvaluating Anodal tDCS Preceding Aphasia Therapy
Primary Purpose
Stroke, Aphasia
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, aphasia, CVA, apraxia, cerebrovascular accident, cerebral stroke, speech therapy, aphasia therapy, non-invasive brain stimulation, transcranial direct current stimulation, tDCS
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years of age
- First single focal unilateral left hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
- Pre-morbidly right handed
- Pre-morbidly fluent English speaker
- Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist)
- A baseline Aphasia Quotient score between 10 to 94 out of 100 points on the Western Aphasia Battery (neither completely without language comprehension/expression nor fully recovered from aphasia).
Exclusion Criteria:
- Ongoing use of CNS-active medications
- Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
Presence of additional potential tDCS risk factors:
- Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
- Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system
- Metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation)
- A history of medication-resistant epilepsy in the family
- Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months
- Pregnancy in women, as determined by self-report
Sites / Locations
- Feinstein Institute for Medical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
anodal tDCS, then sham tDCS
sham tDCS, then anodal tDCS
Arm Description
Participants received 1 single 20 min session of anodal tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of sham tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.
Participants received 1 single 20 min session of sham tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of anodal tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.
Outcomes
Primary Outcome Measures
Mean Change in Picture-naming Accuracy Score
The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02249819
Brief Title
Evaluating Anodal tDCS Preceding Aphasia Therapy
Official Title
Evaluating Anodal tDCS Preceding Aphasia Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Study Start Date
September 2014 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if non-invasive brain stimulation (transcranial direct current stimulation) delivered prior to language therapy will improve word-finding in individuals with aphasia who are 6 months or greater post-stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia
Keywords
stroke, aphasia, CVA, apraxia, cerebrovascular accident, cerebral stroke, speech therapy, aphasia therapy, non-invasive brain stimulation, transcranial direct current stimulation, tDCS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
All participants received both stimulation conditions (active tDCS + computerized naming therapy and sham tDCS + computerized naming therapy), separated by a 1-week washout period.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sequence of stimulation conditions was randomized across subjects.
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anodal tDCS, then sham tDCS
Arm Type
Experimental
Arm Description
Participants received 1 single 20 min session of anodal tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of sham tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.
Arm Title
sham tDCS, then anodal tDCS
Arm Type
Experimental
Arm Description
Participants received 1 single 20 min session of sham tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of anodal tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
Soterix 1x1 anodal tDCS
Primary Outcome Measure Information:
Title
Mean Change in Picture-naming Accuracy Score
Description
The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).
Time Frame
baseline, discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years of age
First single focal unilateral left hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
Pre-morbidly right handed
Pre-morbidly fluent English speaker
Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist)
A baseline Aphasia Quotient score between 10 to 94 out of 100 points on the Western Aphasia Battery (neither completely without language comprehension/expression nor fully recovered from aphasia).
Exclusion Criteria:
Ongoing use of CNS-active medications
Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
Presence of additional potential tDCS risk factors:
Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system
Metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation)
A history of medication-resistant epilepsy in the family
Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months
Pregnancy in women, as determined by self-report
Facility Information:
Facility Name
Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18096677
Citation
Monti A, Cogiamanian F, Marceglia S, Ferrucci R, Mameli F, Mrakic-Sposta S, Vergari M, Zago S, Priori A. Improved naming after transcranial direct current stimulation in aphasia. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):451-3. doi: 10.1136/jnnp.2007.135277. Epub 2007 Dec 20.
Results Reference
background
PubMed Identifier
20395612
Citation
Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.
Results Reference
background
PubMed Identifier
20946060
Citation
Fiori V, Coccia M, Marinelli CV, Vecchi V, Bonifazi S, Ceravolo MG, Provinciali L, Tomaiuolo F, Marangolo P. Transcranial direct current stimulation improves word retrieval in healthy and nonfluent aphasic subjects. J Cogn Neurosci. 2011 Sep;23(9):2309-23. doi: 10.1162/jocn.2010.21579. Epub 2010 Oct 14.
Results Reference
background
PubMed Identifier
23060684
Citation
Holland R, Crinion J. Can tDCS enhance treatment of aphasia after stroke? Aphasiology. 2012 Sep;26(9):1169-1191. doi: 10.1080/02687038.2011.616925. Epub 2011 Nov 3.
Results Reference
background
PubMed Identifier
24333381
Citation
Marangolo P, Fiori V, Campana S, Calpagnano MA, Razzano C, Caltagirone C, Marini A. Something to talk about: enhancement of linguistic cohesion through tdCS in chronic non fluent aphasia. Neuropsychologia. 2014 Jan;53:246-56. doi: 10.1016/j.neuropsychologia.2013.12.003. Epub 2013 Dec 11.
Results Reference
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Evaluating Anodal tDCS Preceding Aphasia Therapy
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