Using tDCS in Speech-based Stroke Rehabilitation

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT03452202
Status
Recruiting

Conditions

  • Apraxia of Speech

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Soterix 1x1 line tDCS low-intensity stimulator — DEVICE
    Introduction of the independent variable (treatment) across three different points in time. Participants will be randomly assigned to have each treatment phase begin after 3, 4, or 6 baseline sessions. This current stimulates the cortex, with anodal stimulation leading to a depolarized state in which neurons are more likely to fire.
  • Sham — DEVICE
    Patients will have two electrodes applied (one anode, one cathode) administering no stimulation

Study Details

The purpose of this study is to determine whether the effect of treatment for acquired speech impairment can be enhanced by combining effective behavioral treatment with non-invasive brain stimulation. Transcranial direct current stimulation (tDCS), which delivers low-intensity current to the scalp, and is a safe and well-tolerated approach that poses a non-significant risk to participants. tDCS provides low intensity neural stimulation which has been shown to facilitate motor learning in other domains of stroke rehabilitation such as arm motor learning but the potential to enhance speech motor learning has not been explored. This will be examined with a series of single-case experimental designs.

Key Dates

Start date
Jan 11, 2019
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Active Stimulation
    crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition.
  • Sham Comparator: Sham Stimulation
    crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition.

Primary Outcome Measure

Change in accuracy in recordings from tasks from baseline to post treatment [ Time Frame: Baseline, 6 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
New York University School of MedicineNew YorkNew York10016
Buchwald Lab
Adam
Adam Buchwald, PhD (PRINCIPAL_INVESTIGATOR)
Burke Rehabilitation HospitalWhite PlainsNew York10605
Josette Hartnett, MPH
Erika Trovato, DO (PRINCIPAL_INVESTIGATOR)

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