- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01686373
Brain Stimulation and Aphasia Treatment (tDCS)
July 31, 2019 updated by: Julius Fridriksson, University of South Carolina
Transcranial Direct Current Stimulation and Aphasia Treatment Outcomes
The purpose of this study is to assess the changes in language processing of patients with chronic, post-stroke aphasia following the application of brain stimulation.
The brain stimulation the investigators administer is called transcranial direct current stimulation (tDCS).
It involves passing a weak electrical current through the brain between two electrodes in the form of damp sponges.
One sponge will be placed over a specified area on the damaged left hemisphere, while the other sponge will be placed on the right scalp.
Computer-controlled speech-language treatment will be administered during the application of tDCS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Stroke is the leading cause of adult disability in the United States.
Approximately one-third of all strokes result in acute language impairment (aphasia), with approximately one-fifth suffering from chronic aphasia.
Unfortunately, the prognosis for moderate to severe chronic aphasia remains grim, as current behavioral treatment approaches usually offer only limited-to-modest benefit.
Recent advancements in understanding the relationship between low current electrical brain stimulation and cortical plasticity suggest that the effect of behavioral aphasia treatment could possibly be enhanced using anodal transcranial direct current stimulation (A-tDCS).
Indeed, we have shown how A-tDCS can significantly boost the effect of behavioral aphasia treatment.
Based on these results as well as our other studies aimed at understanding how favorable brain plasticity correlates with positive treatment outcome in aphasia, we propose to conduct a Phase II clinical trial utilizing a futility design.
Consistent with the goals of Program Announcement PAR-08-204 by the National Institute on Deafness and Other Communication Disorders (NIDCD), we plan to "evaluate whether there is sufficient evidence of short term improvement in humans to justify a phase III trial."
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina (USC)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must be willing and able to give informed consent.
- Patients must be willing and able to comply with study requirements.
- Patients must be between 25- and 80-years of age.
- Patients must be native English speakers.
- Patients must be pre-morbidly right-handed.
- Patients must have sustained a one-time ischemic stroke in the left-hemisphere.
- Patients must be greater than 6-months post-stroke.
- Patients must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised.
- Patients must be MRI-compatible (e.g., no metal implants, not claustrophobic, etc.).
- Patients must achieve at least 65% accuracy on naming task during screening -
Exclusion Criteria:
- History of brain surgery
- Seizures during the previous 12 months
- Sensitive scalp (per patient report)
- Able to overtly name more than an average of 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test) during Visits 2 or 3.
- Unable to overtly name at least an average of 5 out of 80 items during the pre-treatment functional magnetic resonance imaging (fMRI) sessions during Visits 2 or 3.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Activa Dose II Real tDCS
Actual delivery of electrical stimulation
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20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions)
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Placebo Comparator: Activa Dose II Sham tDCS
Sham delivery of electrical stimulation
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20 minutes of sham stimulation per treatment day (15 total sessions)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items).
Time Frame: Immediately post-treatment
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The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly).
The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly).
For both scales, higher values represent better outcome.
The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points.
The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment.
Only two timepoints are used for this calculation: baseline and immediately post-treatment.
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Immediately post-treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julius Fridriksson, PhD, Director
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
September 7, 2012
First Submitted That Met QC Criteria
September 12, 2012
First Posted (Estimate)
September 18, 2012
Study Record Updates
Last Update Posted (Actual)
August 20, 2019
Last Update Submitted That Met QC Criteria
July 31, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11560FA12
- U01DC011739 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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