NCT04547569

Brief Summary

These studies test the hypothesis that frontal areas of the brain participate in the cortical networks involved in the somotosensory processing that happens during speech motor learning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2021

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

September 7, 2020

Last Update Submit

May 31, 2022

Conditions

SpeechMotor Activity

Outcome Measures

Primary Outcomes (2)

  • Motor Learning

    Learning is assessed as percentage change in speech sounds (speech formant frequencies) relative to baseline.

    Performance as measured at the end of learning (during the 1h30 scanner session)

  • Brain activity

    Brain activity are measure by the BOLD signal during both task-based and resting-state blocks

    1h30 scanner session

Study Arms (3)

Adaptation to altered auditory feedback

EXPERIMENTAL

fMRI measurement of brain activity during speech production under altered auditory feedback

Behavioral: Speech adaptationOther: fMRI

Speech production

EXPERIMENTAL

fMRI measurement of brain activity during normal speech production

Other: fMRIBehavioral: Speech production

Vibrotactile discrimination

EXPERIMENTAL

fMRI measurement of brain activity during a vibrotactile discrimination task

Behavioral: Vibrotactile DiscriminationOther: fMRI

Interventions

Speech adaptationBEHAVIORAL

Sensorimotor adaptation in speech

Adaptation to altered auditory feedback
Vibrotactile DiscriminationBEHAVIORAL

Vibrotactile Discrimination

Vibrotactile discrimination
fMRIOTHER

fMRI measurement of brain activity

Adaptation to altered auditory feedbackSpeech productionVibrotactile discrimination
Speech productionBEHAVIORAL

Speech production task

Speech production

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Right-handed subjects
  • Subjects fluent in French
  • Signed informed consent
  • Affiliation to or beneficiary of a Social Security scheme

You may not qualify if:

  • Left-handed subjects
  • Criteria for contraindications to protocol fMRI scans
  • Existence of a severe general condition: cardiac, respiratory, hematological, renal, hepatic, cancerous.
  • Hearing, language (including dyslexia), neurological or psychiatric disorders.
  • Drug treatment likely to modulate brain activity: benzodiazepines, antidepressants, neuroleptics, lithium, etc.
  • Protected persons referred to in articles L1121 5 to L1121 8 of the French CSP:
  • Pregnant women, parturients, nursing mothers,
  • Persons deprived of liberty by a judicial or administrative decision,
  • Persons under psychiatric care,
  • Individuals admitted to a health or social institution for purposes other than research,
  • Minors,
  • Persons over the age of majority who are subject to a legal protection measure or who are unable to express their consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble-Alpes

Grenoble, 38043, France

Location

MeSH Terms

Conditions

SpeechMotor Activity

Interventions

Speech, Alaryngeal

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

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

September 7, 2020

First Posted

September 14, 2020

Study Start

October 20, 2020

Primary Completion

July 6, 2021

Study Completion

July 6, 2021

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations

FR(1)