Brain Stimulation and Aphasia Treatment (tDCS)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Aphasia |
Device: Activa Dose II Real tDCS Device: Activa Dose II Sham tDCS |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Transcranial Direct Current Stimulation and Aphasia Treatment Outcomes |
- Correct Naming on the Philadelphia Naming Test [ Time Frame: Immediately post-treatment and at follow-up ] [ Designated as safety issue: No ]Number of pictures named correctly on the test
| Estimated Enrollment: | 75 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2017 |
| Estimated Primary Completion Date: | April 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Activa Dose II Real tDCS
Actual delivery of electrical stimulation
|
Device: Activa Dose II Real tDCS |
|
Placebo Comparator: Activa Dose II Sham tDCS
Sham delivery of electrical stimulation
|
Device: Activa Dose II Sham tDCS |
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."
Eligibility| Ages Eligible for Study: | 25 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 fMRI sessions during Visits 2 or 3.
Contacts and Locations| Contact: Astrid Fridriksson, M.A, CCC-SLP | 803-777-2693 | fridrika@mailbox.sc.edu |
| Contact: Ivia Smith, M.S. | 803-777-1087 | ivia.smith@sc.edu |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Sheri Davis 843-792-2845 davshe@musc.edu | |
| Contact: JoAnn Fisher joannjfisher4@gmail.com | |
| Principal Investigator: Julius Fridriksson, PhD | |
| University of South Carolina (USC) | Recruiting |
| Columbia, South Carolina, United States, 29208 | |
| Contact: Astrid Fridriksson, M.A., CCC-SLP 803-777-2693 fridrika@mailbox.sc.edu | |
| Contact: Ivia Smith, M.S. 803-777-1087 ivia.smith@sc.edu | |
| Principal Investigator: | Julius Fridriksson, PhD | Director |
More Information
Additional Information:
No publications provided
| Responsible Party: | Julius Fridriksson, Professor, University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT01686373 History of Changes |
| Other Study ID Numbers: | 11560FA12 |
| Study First Received: | September 7, 2012 |
| Last Updated: | February 7, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by University of South Carolina:
|
Aphasia Brain Stimulation Communication Stoke |
Post Phase II Clinical Trial Treatment tDCS Fridriksson |
Additional relevant MeSH terms:
|
Aphasia Speech Disorders Language Disorders Communication Disorders |
Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013