NCT03452202

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2019Oct 2026

First Submitted

Initial submission to the registry

January 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

January 11, 2019

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

7.8 years

First QC Date

January 16, 2018

Last Update Submit

July 28, 2025

Conditions

Apraxia of Speech

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

  • Change in accuracy in recordings from tasks from baseline to post treatment

    Subjects will be given speech production tasks. Recordings of tasks will be scored for accuracy to measure speech motor learning

    Baseline, 6 Months

Study Arms (2)

Active Stimulation

EXPERIMENTAL

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.

Device: Soterix 1x1 line tDCS low-intensity stimulatorDevice: Sham

Sham Stimulation

SHAM COMPARATOR

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.

Device: Soterix 1x1 line tDCS low-intensity stimulatorDevice: Sham

Interventions

Soterix 1x1 line tDCS low-intensity stimulatorDEVICE

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.

Also known as: Soterix
Active StimulationSham Stimulation
ShamDEVICE

Patients will have two electrodes applied (one anode, one cathode) administering no stimulation

Active StimulationSham Stimulation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York University School of Medicine

New York, New York, 10016, United States

RECRUITING

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

RECRUITING

MeSH Terms

Conditions

ApraxiasStroke

Condition Hierarchy (Ancestors)

Psychomotor DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Adam Buchwald, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Buchwald Lab

CONTACT

buchwald-lab@nyu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2018

First Posted

March 2, 2018

Study Start

January 11, 2019

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

July 29, 2025

Record last verified: 2025-07

Locations

US(2)