Using tDCS in Speech-based Stroke Rehabilitation

NCT03452202 — Not applicable, Recruiting, 24 participants, NYU Langone Health

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Registry	NCT03452202
Status	Recruiting
Phase	Not applicable
Study type	Interventional; non randomized, crossover, masking: double, treatment
Enrollment	24 (Estimated)
Sponsor	NYU Langone Health (Other); collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions	Apraxia of Speech
Interventions	Soterix 1x1 line tDCS low-intensity stimulator, Sham (Device)
Dates	start 2019-01-11, primary completion 2027-04-30 (estimated), completion 2027-04-30 (estimated), first posted 2018-03-02, last updated 2026-06-03
Locations	2 sites in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Active Stimulation	Experimental	Device: Soterix 1x1 line tDCS low-intensity stimulator; Device: Sham	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 Stimulation	Sham comparator	Device: Soterix 1x1 line tDCS low-intensity stimulator; Device: Sham	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.

Soterix 1x1 line tDCS low-intensity stimulator (Device), also known as Soterix: 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

+Outcome measures

Primary outcomes

Change in accuracy in recordings from tasks from baseline to post treatment [Baseline, 6 Months]: Subjects will be given speech production tasks. Recordings of tasks will be scored for accuracy to measure speech motor learning

+Eligibility

Sex: All, ages: 18 Years to 99 Years

Inclusion Criteria:

* Right-handed
* Monolingual (English)
* Single left-hemisphere CVA
* A minimum of six months post-stroke
* Clinical diagnosis of apraxia of speech
* Normal speech perception
* Passing score on the hearing screening.

Exclusion Criteria:

* Diagnosis of laryngeal voice disorder
* Dysarthria
* History of speech impairment prior to CVA
* Presence of potential tDCS risk factors: damaged skin at site of stimulation;
* Presence of electrically or magnetically activated implant (including pacemaker);
* metal in any part of their body;
* history of medication-resistant epilepsy in the family;
* past history of seizures or unexplained spells of loss of consciousness.

+Locations (2)

Facility	City	Country	Status
New York University School of Medicine	New York, New York	United States	Recruiting
Burke Rehabilitation Hospital	White Plains, New York	United States	Recruiting

+Investigators

Adam Buchwald, MD, Principal investigator, NYU Langone Health

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