Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03452202
Other study ID # 17-01474
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 11, 2019
Est. completion date October 30, 2025

Study information

Verified date September 2023
Source NYU Langone Health
Contact Maria Cuervo Cano
Email mcc816@nyu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date October 30, 2025
Est. primary completion date October 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Soterix 1x1 line tDCS low-intensity stimulator
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
Patients will have two electrodes applied (one anode, one cathode) administering no stimulation

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT01979159 - A Novel Treatment for Aphasia and Apraxia of Speech : Measurement of Outcomes N/A
Recruiting NCT05584033 - Searching of Apraxia of Speech in Children With Specific Language Impairment
Recruiting NCT03700151 - Efficacy of an Intervention for the Children With Severe Speech Sounds Disorders N/A
Completed NCT02554513 - Apraxia of Speech: Comparison of EPG Treatment (Tx) and Sound Production Treatment (SPT) N/A
Enrolling by invitation NCT04680130 - Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders
Completed NCT02332915 - Treatment Intensity - Apraxia of Speech N/A
Recruiting NCT02094014 - Auditory Masking Effects on Speech Fluency in Aphasia and Apraxia of Speech N/A
Completed NCT01623284 - PiB PET Scanning in Speech and Language Based Dementias Phase 1
Completed NCT04957225 - MIRAA - Implementation of Intensive Rehabilitation of Aphasia and/or Apraxia of Speech in Swedish Healthcare N/A
Enrolling by invitation NCT05368350 - Treating Primary Progressive Aphasia and Apraxia of Speech Using Non-invasive Brain Stimulation Early Phase 1
Recruiting NCT04816799 - Efficacy of START (Startle Rehabilitation Therapy) in the Treatment Stroke-induced Aphasia/Apraxia Early Phase 1
Recruiting NCT01818661 - Longitudinal Multi-Modality Imaging in Progressive Apraxia of Speech Phase 4
Recruiting NCT04604444 - Changes in Neuroplasticity Following Intensive Rehabilitation of Aphasia and/or Apraxia of Speech N/A
Recruiting NCT05248295 - Investigating the Effects of Rhythm and Entrainment on Fluency in People With Aphasia N/A
Recruiting NCT06467136 - Motor Imagery for Treatment Enhancement and Efficacy in Persons With Apraxia of Speech N/A
Completed NCT04764539 - Video Assisted Speech Technology to Enhance Motor Planning for Speech N/A
Recruiting NCT03313011 - The Neurobiology of Two Distinct Types of Progressive Apraxia of Speech
Completed NCT01483807 - Treatments of Acquired Apraxia of Speech N/A
Available NCT03327467 - Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries