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

NCT03773406 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-07-26

No results posted yet for this study

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

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

Offline tDCS-after 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.

DEVICE

Online tDCS

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.

Sponsors & Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

    collaborator FED
  • Shirley Ryan AbilityLab

    lead OTHER

Principal Investigators

  • Leora Cherney, PhD · Shirley Ryan AbilityLab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03773406 on ClinicalTrials.gov