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Brain Stimulation and Aphasia Treatment (tDCS)

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ClinicalTrials.gov Identifier: NCT01686373
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Medical University of South Carolina
Information provided by (Responsible Party):
Julius Fridriksson, University of South Carolina

Tracking Information
First Submitted Date  ICMJE September 7, 2012
First Posted Date  ICMJE September 18, 2012
Results First Submitted Date  ICMJE April 17, 2019
Results First Posted Date  ICMJE August 20, 2019
Last Update Posted Date August 20, 2019
Study Start Date  ICMJE April 2012
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2019)
The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items). [ Time Frame: Immediately post-treatment ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brain Stimulation and Aphasia Treatment
Official Title  ICMJE Transcranial Direct Current Stimulation and Aphasia Treatment Outcomes
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Aphasia
Intervention  ICMJE
  • Device: Activa Dose II Real tDCS
    20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions)
  • Device: Activa Dose II Sham tDCS
    20 minutes of sham stimulation per treatment day (15 total sessions)
Study Arms  ICMJE
  • Experimental: Activa Dose II Real tDCS
    Actual delivery of electrical stimulation
    Intervention: Device: Activa Dose II Real tDCS
  • Placebo Comparator: Activa Dose II Sham tDCS
    Sham delivery of electrical stimulation
    Intervention: Device: Activa Dose II Sham tDCS
Publications * Fridriksson J, Rorden C, Elm J, Sen S, George MS, Bonilha L. Transcranial Direct Current Stimulation vs Sham Stimulation to Treat Aphasia After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2018 Dec 1;75(12):1470-1476. doi: 10.1001/jamaneurol.2018.2287.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2019)
74
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2012)
75
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 functional magnetic resonance imaging (fMRI) sessions during Visits 2 or 3.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01686373
Other Study ID Numbers  ICMJE 11560FA12
U01DC011739 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julius Fridriksson, University of South Carolina
Study Sponsor  ICMJE University of South Carolina
Collaborators  ICMJE
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • Medical University of South Carolina
Investigators  ICMJE
Principal Investigator: Julius Fridriksson, PhD Director
PRS Account University of South Carolina
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP