Establish the Role of Premotor and Motor Cortices in tDCS-facilitated Speech Motor Learning

NCT05804344 | Recruiting FDA Device

• 1 other identifier: 206731
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Groups of unimpaired participants will all receive speech motor training of nonwords, and six tDCS conditions will be compared: anodal tDCS over speech motor regions; cathodal tDCS over speech motor regions; anodal tDCS over left frontal regions; cathodal tDCS over left frontal regions; cathodal stimulation over non-speech motor regions (anodal already collected);and sham tDCS (no stimulation). This will address a basic science question about whether the mechanism underlying speech motor learning requires premotor and motor cortical regions to be stimulated, which has implications for treatment of acquired speech impairment. The primary outcome measure will be the difference in production accuracy and changes in motor acuity (measured with duration) of novel consonant cluster production.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in percentage of accurately produced words from baseline to retention

  Measure will be taken from recordings during motor learning task and at two retention time points. Evaluation of accuracy of each word will be based upon the acoustic signal and the presence of incorrect sounds will be considered an error. Each word will be evaluated for accuracy, and the overall percentage will be the primary variable.

  Baseline, 2 days after training

Secondary Outcomes (1)

• Change in duration from first consonant to second consonant from baseline to retention

  Baseline, 2 days after training

Study Arms (5)

Anodal speech motor tDCS (Anode: C5; Cathode: Fp2)

EXPERIMENTAL

Speech motor learning task performed with the stimulation condition in the arm title.

Device: Anodal speech motor tDCS

Cathodal speech motor tDCS (Anode: Fp2; Cathode: C5)

ACTIVE COMPARATOR

Speech motor learning task performed with the stimulation condition in the arm title.

Device: Cathodal speech motor tDCS

Anodal IFG tDCS (Anode: F3; Cathode: Fp2)

ACTIVE COMPARATOR

Speech motor learning task performed with the stimulation condition in the arm title.

Device: Anodal IFG tDCS

Cathodal IFG tDCS (Cathode: F3; Anode: Fp2)

ACTIVE COMPARATOR

Speech motor learning task performed with the stimulation condition in the arm title.

Device: Cathodal IFG tDCS

Sham tDCS

SHAM COMPARATOR

Speech motor learning task performed with the stimulation condition in the arm title.

Device: Sham tDCS

Interventions

Anodal speech motor tDCS DEVICE

tDCS montage set for Anode: C5; Cathode: Fp2

Anodal speech motor tDCS (Anode: C5; Cathode: Fp2)

Cathodal speech motor tDCS DEVICE

tDCS montage set for Anode: Fp2; Cathode: C5

Cathodal speech motor tDCS (Anode: Fp2; Cathode: C5)

Anodal IFG tDCS DEVICE

tDCS montage set for Anode: F3; Cathode: Fp2

Anodal IFG tDCS (Anode: F3; Cathode: Fp2)

Cathodal IFG tDCS DEVICE

tDCS montage set for Anode: Fp2; Cathode: F3

Cathodal IFG tDCS (Cathode: F3; Anode: Fp2)

Sham tDCS DEVICE

tDCS device set in Sham mode

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• native English speaker (learned English in the home from birth)
• no exposure to languages that contain the trained consonant clusters (e.g., Slavic languages, Greek, Hebrew).

You may not qualify if:

• a history of speech, language or hearing disorder
• not passing a hearing screening (40 dB HL; ANSI: 1983) at 500, 1000, 2000, 4000Hz binaurally
• presence of potential tDCS risk factors: damaged skin at site of stimulation; presence of electrically or magnetically activated implant (including pacemaker); and metal in any part of their body

Sponsors & Collaborators

• New York University: lead

Study Sites (1)

New York University Department of Communicative Sciences and Disorders

New York, New York, 10012, United States

RECRUITING

Study Officials

• Adam Buchwald, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Buchwald, Phd

CONTACT

2129985260; buchwaldlab.nyu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Device is pre-set so that individual applying stimulation does not know what condition is being applied. Participants are not informed either. All data are coded by individuals who are not informed as to the condition of the participants.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All five groups are compared in a linear mixed effects model.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 7, 2023
• Study Start: October 25, 2022
• Primary Completion: October 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 25, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)