Aphasia rehabilitation with tDCS as added to speech therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind trial compares auditory-visual speech therapy with active anodal tDCS to speech therapy with sham tDCS in adults with chronic Broca's aphasia. An adaptive Phase II/III design will identify the optimal tDCS dose (1 mA vs 2 mA) in Phase II and then test the confirmed dose in Phase III. Stimulation uses the 10-10 electrode system with 5 x 5 cm pads for 20 minutes per session, alongside speech therapy aiming to improve naming abilities. Participants must have had a left-hemisphere stroke and Broca's aphasia for more than six months, among other criteria, and will be randomized to active or sham tDCS. The study is conducted at multiple sites in the southeastern and western United States.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting
• University of South Carolina
  Columbia, South Carolina, United States Recruiting
• University of Utah
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Leonardo Bonilha
• Email: Leonardo.Bonilha@uscmed.sc.edu
• Phone: 803-216-3469

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study tests whether language and general cognitive networks contribute to language recovery after stroke in people with aphasia.

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• Tailoring rTMS for Post-Stroke Aphasia Based on Language Profile

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• LEXURE digital language therapy for post-stroke aphasia

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  Recruiting at 8 sites Nunaps Inc · Ansan, Gyeonggi-do and 11 other locations · NCT07570264

• tDCS in Rehab for Stroke-Related Aphasia: A Practical Implementation

  This study tests whether a 20-minute anodal tDCS session paired with speech therapy can be integrated into routine inpatient and outpatient rehab for people who recently had a stroke and now have aphasia.

  Recruiting Casa Colina Hospital and Centers for Healthcare · Pomona, California · NCT07535788

• New tools to measure language, gestures, and everyday communication in people with aphasia

  This project will test new ways to measure language, gestures, and everyday communication skills in adults with aphasia after stroke.

  Recruiting IRCCS San Camillo, Venezia, Italy · Venice, VE · NCT07518576

• Decoding Mandarin speech features from brain-surface signals

  This project will try to decode imagined Mandarin speech, including lexical tones, from high-density brain-surface (ECoG) signals in adult patients who are having clinically indicated cortical electrode placement.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07460037

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.