Recruiting

tDCS & SLTTiming of Transcranial Direct Current Stimulation (tDCS) Combined With Speech and Language Therapy (SLT)

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT03773406

Conditions

Aphasia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Offline tDCS-before therapy

Sham tDCS

Offline tDCS-after therapy

Online tDCS

Study Details

Brief summary:

Aphasia is an acquired (typically left-hemisphere) multi-modality disturbance of language that impacts around 2 million people in the USA. Aphasia impacts language production and comprehension as well as reading and writing. The ramifications of aphasia extend beyond language impairment to negatively impacting a person's social, vocational, and recreational activities. Currently, the most effective way to treat aphasia is with speech-language therapy (SLT). However, even if SLT is intensive, persons with aphasia are left with residual language delays. Recent research suggests that pairing SLT with transcranial direct current stimulation (tDCS) a non-invasive, safe, low-cost form of brain stimulation may aid language recovery in persons with aphasia. However, results from tDCS studies are inconclusive. The success of tDCS in combination with SLT could depend on the timing of tDCS since tDCS-induced effects depend on the neuronal state of the brain-networks at the time of the stimulation. In this study, the differential impact of tDCS before behavioral SLT (offline-before therapy), tDCS after SLT (offline-after therapy), and tDCS concurrently with SLT (online) on functional language recovery in persons with aphasia will be investigated. Sham tDCS (i.e., SLT alone) as a control group will also be included in the study. The investigators hypothesize that both offline and online tDCS will improve language functioning than sham tDCS.

Conditions

Aphasia

Study ID

NCT03773406

Start date

Apr 3, 2019

Status verified date

Jul, 2022

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Men or women with diagnosis of fluent or non-fluent aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by a MRI or CT scan
Aphasia quotient on the WAB of 35-85
At least 6 months post onset of aphasia (this is beyond the stage of spontaneous recovery)
18- 80 years of age
Premorbidly fluent in English
Premorbidly right-hand dominant per the Edinburg Handedness Inventory
Visual acuity of 20/40 corrected
Auditory acuity no worse than 30 dB HL on pure tone testing, aided in the better ear.
Education greater than 12th grade

Exclusion Criteria:

Any other neurological condition (other than cerebral vascular disease) that could impact language and cognition such as Alzheimer's disease, Parkinson's disease, primary progressive aphasia, and traumatic brain injury
Active substance use
Individuals with epilepsy

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Offline tDCS-before therapy

Participants will receive 20 minutes of tDCS prior to the 40 minute speech-language therapy session.

active comparator: Offline tDCS-after therapy

Participants will receive 20 minutes of tDCS after the 40 minute speech-language therapy session.

active comparator: Online tDCS

tDCS will be applied at the beginning of the 40 minute speech-language therapy session and will last for 20 minutes.

sham comparator: Sham tDCS

Sham tDCS will be applied at the beginning of the 40 minute speech-language therapy session.

Interventions

Offline tDCS-before therapy

Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.

Sham tDCS

Stimulation will be given for a total 30 seconds (including ramp-up and ramp-down of current) and then the tDCS device will be turned off. The brief stimulation will produce tDCS-induced sensation so that participants will not be aware when the tDCS was turned off .We will use standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.

Offline tDCS-after therapy

Online tDCS

Primary outcome measure

Change in trained conversational script. [ Time Frame: 3 weeks. ]

Central Contacts and Locations

Central contacts

Leora Cherney, PhD

312-238-1117 lcherney@sralab.org

Sameer Ashaie, PhD

312-238-6163 sameer.ashaie@northwestern.edu

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Leora Cherney, PhD

312-238-1117 lcherney@sralab.org

Sameer Ashaie, PhD

312-238-6163 sameer.ashaie@northwestern.edu

Principal Investigator:

Leora Cherney, PhD

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Jul 26, 2022

Last verified

Jul, 2022

Keywords

Aphasia, tDCS, Script training, Functional language, Naming

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2022-07-26.