Brain Stimulation and Aphasia Treatment
tDCS
Transcranial Direct Current Stimulation and Aphasia Treatment Outcomes
2 other identifiers
interventional
74
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2012
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 7, 2012
CompletedFirst Posted
Study publicly available on registry
September 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedResults Posted
Study results publicly available
August 20, 2019
CompletedAugust 20, 2019
July 1, 2019
5.1 years
September 7, 2012
April 17, 2019
July 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items).
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.
Immediately post-treatment
Study Arms (2)
Activa Dose II Real tDCS
EXPERIMENTALActual delivery of electrical stimulation
Activa Dose II Sham tDCS
PLACEBO COMPARATORSham delivery of electrical stimulation
Interventions
20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions)
20 minutes of sham stimulation per treatment day (15 total sessions)
Eligibility Criteria
You may qualify if:
- 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 -
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of South Carolina (USC)
Columbia, South Carolina, 29208, United States
Related Publications (1)
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.
PMID: 30128538DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Julius Fridriksson
- Organization
- University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
Julius Fridriksson, PhD
Director
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 7, 2012
First Posted
September 18, 2012
Study Start
April 1, 2012
Primary Completion
May 1, 2017
Study Completion
October 1, 2017
Last Updated
August 20, 2019
Results First Posted
August 20, 2019
Record last verified: 2019-07