Superiority Trial of Aphasia-focused Rehabilitation With tDCS Stimulation
Recruiting
Phase 2Phase 3Interventional Study
AphasiaBroca's Aphasia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
25 – 80
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
130 (estimated)
Sponsor
University of South Carolina · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this study is to help us understand if adding transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, to Speech Therapy improves language recovery in people with Broca's aphasia and is more effective than Speech Therapy alone.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Be willing and able to give informed consent.
* Be willing and able to comply with study requirements.
* Be between 25 and 80 years of age.
* Have used English as the primary language for \> 15 years.
* Have the diagnosis of aphasia due to a left hemisphere stroke, confirmed b…
Inclusion Criteria:
* Be willing and able to give informed consent.
* Be willing and able to comply with study requirements.
* Be between 25 and 80 years of age.
* Have used English as the primary language for \> 15 years.
* Have the diagnosis of aphasia due to a left hemisphere stroke, confirmed by study physician based on past clinical MRI scan or research scan.
* Be greater than 6 months post-stroke.
* Have Broca's aphasia diagnosed by the WAB-R (fluency score ≤ 5, auditory verbal comprehension score 4-10, repetition score 0-7.9, naming and word finding score \< 9).
* Correctly name 140 or fewer items on the PNT.
Exclusion Criteria:
* History of brain surgery except for during the treatment of the acute stroke.
* Seizures during the previous 12-months.
* Compromised skin at or near electrode sites (e.g., rash, eczema, wounds, infection).
* Correctly name more than 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test).
* Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) score of 25 or below.
* Participants with open skull defects (e.g., greater than 1 cm) in the area underneath the anode electrode positioning or participants with metal implants or electrical stimulators.
* Participants with continuous oxygen therapy which cannot be discontinued for more than 1 hour.
* Any condition or situation that the PI determines would significantly interfere with the participant's ability to complete the study.
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