Superiority Trial of Aphasia-focused Rehabilitation With tDCS Stimulation (STARS)

University of South Carolina

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Broca's Aphasia

Aphasia

Treatments

Device: tDCS

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07688551

U01DC022447 (U.S. NIH Grant/Contract)

STUDY00000004

Details and patient eligibility

About

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.

Full description

This project is a prospective randomized controlled double-blinded clinical trial to compare auditory-visual speech therapy coupled with adjuvant active anodal tDCS (A-tDCS) versus speech therapy coupled with sham tDCS (S-tDCS). The investigators will perform an adaptive Phase II/III design, in which the first portion of the study (Phase II) will determine the optimal dose of A-tDCS (1 mA versus 2 mA) and provide a go/no-go decision for Phase III. The investigators will use a 10-10 system to determine electrode placement, with 5 x 5 cm pads, and stimulation duration will be 20 minutes. Phase III will test the definitive superiority of adjuvant A-tDCS at the optimal dose coupled with speech therapy versus speech therapy alone (S-tDCS) to improve naming among individuals with chronic Broca's aphasia.

Enrollment

130 estimated patients

Sex

All

Ages

25 to 80 years old

Volunteers

No Healthy Volunteers

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.