NCT04497428

Brief Summary

These studies test the hypothesis that sensory areas of the brain participate in the consolidation of speech motor memory by using transcranial magnetic stimulation to suppress activity in somatosensory and auditory cortex following adaptation in order to block retention of learning.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 Start

First participant enrolled

August 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 29, 2026

Completed
Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

6 years

First QC Date

July 30, 2020

Results QC Date

July 21, 2026

Last Update Submit

September 1, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mean Percent Change in F1 to Assess Motor Learning

    Learning is assessed as change in speech sounds (speech formant frequencies, F1) relative to baseline. The first formant frequency (F1) is the lowest resonant frequency of the vocal tract. Lower F1 Numbers Indicate a high or "closed" tongue position). Higher F1 Numbers indicate a low or "open" jaw position. Absolute numbers vary depending on a person's age and vocal tract size. Percent change calculated as ((F1 end of learning value minus F1 baseline value)/ F1 baseline value)\*100).

    Baseline and end of learning (30 minute session)

  • Mean Percent Change in F1 to Assess Retention of Learning

    First formant frequency change (F1) relative to baseline is the dependent measure of retention. Percent change calculated as ((F1 end of retention value minus F1 baseline value)/ F1 baseline value)\*100).

    Baseline and 24 hours after learning (re-test lasts 30 minutes)

Study Arms (4)

Adaptation to Altered Auditory Feedback + cTBS to S1

EXPERIMENTAL

Adaptation to Altered Auditory Feedback + cTBS to S1

Behavioral: AdaptationOther: cTBS

Adaptation to Altered Auditory Feedback + cTBS to A1

EXPERIMENTAL

Adaptation to Altered Auditory Feedback + cTBS to A1

Behavioral: AdaptationOther: cTBS

Adaptation to Altered Auditory Feedback + cTBS to M1

EXPERIMENTAL

Adaptation to Altered Auditory Feedback + cTBS to M1

Behavioral: AdaptationOther: cTBS

Adaptation to Altered Auditory Feedback (Control)

EXPERIMENTAL

Adaptation to Altered Auditory Feedback (Control)

Behavioral: Adaptation

Interventions

AdaptationBEHAVIORAL

Sensorimotor adaptation in speech

Adaptation to Altered Auditory Feedback (Control)Adaptation to Altered Auditory Feedback + cTBS to A1Adaptation to Altered Auditory Feedback + cTBS to M1Adaptation to Altered Auditory Feedback + cTBS to S1
cTBSOTHER

continuous theta-burst stimulation

Adaptation to Altered Auditory Feedback + cTBS to A1Adaptation to Altered Auditory Feedback + cTBS to M1Adaptation to Altered Auditory Feedback + cTBS to S1

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • right handed adults
  • no known physical or neurological abnormalities

You may not qualify if:

  • patients with:
  • cardiac pacemaker
  • surgical clips or values on the heart
  • implants
  • metal or metallic fragments in any part of the body
  • pregnancy
  • claustrophobia
  • a personal or family history of epilepsy
  • currently taking antipsychotic drugs
  • currently taking antidepressant drugs
  • currently taking antianxiety drugs
  • history of concussion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H3A1G1, Canada

Location

MeSH Terms

Conditions

Speech

Interventions

Acclimatization

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Intervention Hierarchy (Ancestors)

Adaptation, PhysiologicalPhysiological PhenomenaAdaptation, BiologicalBiological Phenomena

Results Point of Contact

Title
David Ostry
Organization
Yale University

Study Officials

  • David Ostry

    Haskins Laboratories

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 4, 2020

Study Start

August 1, 2019

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

September 29, 2026

Results First Posted

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations