Superiority Trial of Aphasia-focused Rehabilitation With tDCS Stimulation
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age25-80
SponsorUniversity of South Carolina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
tDCS
DeviceThe study intervention will be delivered using the Soterix 1x1 Transcranial Electrical Stimulation Clinical Trials device (Soterix Medical Inc., New York).
Treatment groups
130 Participants
are divided into 3 treatment groupsGroup A: 1 mA A-tDCSActive comparator 1 intervention
Group B: 2 mA A-tDCSActive comparator 1 intervention
Group C: S-tDCSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Naming
Change in the number of correctly named items between the average of the two pre-treatment Philadelphia Naming Test (PNT) assessments and the average of the two post-treatment PNT sessions at 4-weeks post treatment.
Time frame
From baseline assessment to 4-weeks post treatmentSecondary outcomes
1
Naming
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving naming at 1-week post treatment.
Time frame
From baseline assessment to 1-week post treatment2
Naming
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving naming at 24-weeks post treatment.
Time frame
From baseline assessment to 24-weeks post treatment3
Aphasia Severity
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in reducing aphasia severity as measured by the Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ).
Time frame
From baseline assessment to 4-weeks post treatment4
Functional Communication
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving functional communication.
Time frame
From baseline assessment to 4-weeks post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of South Carolina
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov