Phase 2
N=74
Brain Stimulation and Aphasia Treatment
Aphasia
Bottom Line
View on ClinicalTrials.gov: NCT01686373 ↗Enrolled (actual)
74
Serious AEs
1.4%
Results posted
Aug 2019
Primary outcome: Primary: The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items). — 13.9; 8.2 PNT and Naming 80 score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Activa Dose II Real tDCS (Device); Activa Dose II Sham tDCS (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of South Carolina
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items). |
13.9; 8.2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01686373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.