Brain Stimulation and Aphasia Treatment (tDCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of South Carolina
Sponsor:
Collaborators:
Medical University of South Carolina
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01686373
First received: September 7, 2012
Last updated: February 17, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  1. Patients must be willing and able to give informed consent.
  2. Patients must be willing and able to comply with study requirements.
  3. Patients must be between 25- and 80-years of age.
  4. Patients must be native English speakers.
  5. Patients must be pre-morbidly right-handed.
  6. Patients must have sustained a one-time ischemic stroke in the left-hemisphere.
  7. Patients must be greater than 6-months post-stroke.
  8. Patients must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised.
  9. Patients must be MRI-compatible (e.g., no metal implants, not claustrophobic, etc.).
  10. Patients must achieve at least 65% accuracy on naming task during screening -

Exclusion Criteria:

  1. History of brain surgery
  2. Seizures during the previous 12 months
  3. Sensitive scalp (per patient report)
  4. 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.
  5. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686373

Contacts
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

Locations
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   
Sponsors and Collaborators
University of South Carolina
Medical University of South Carolina
Investigators
Principal Investigator: Julius Fridriksson, PhD Director
  More Information

Additional Information:
No publications provided

Responsible Party: 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 17, 2014
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 July 26, 2014