Sensory Basis of Speech Motor Learning

• Sponsor: Yale University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04497428
• Collaborator: McGill University (Other), National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
• Enrollment: 160
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Speech; Consolidation	Behavioral: Adaptation; Other: cTBS	N/A

Detailed Description

Subjects will train using either altered somatosensory feedback or altered auditory feedback (different groups of subjects). Immediately following adaptation, continuous theta burst magnetic stimulation (cTBS) will be applied to either auditory or somatosensory or motor cortex with the goal of blocking consolidation of motor memory. The logic of applying cTBS to both sensory areas is to test the hypothesis that both areas are involved in motor memory consolidation. Subjects leave the laboratory following cTBS and return 24 hours later to assess retention of learning. Learning is assessed as percentage change in speech sounds or movements relative to baseline. Retention is measured on a 0 to 100 scale relative to the end of learning.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Brain Structures in Speech Motor Memory Consolidation
• Actual Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Jan 31, 2024
• Anticipated Study Completion Date: Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adaptation to Altered Sensory Feedback + cTBS to S1 Adaptation to Altered Sensory Feedback + cTBS to S1	Behavioral: Adaptation; Sensorimotor adaptation in speech; Other: cTBS; continuous theta-burst stimulation
Experimental: Adaptation to Altered Sensory Feedback + cTBS to A1 Adaptation to Altered Sensory Feedback + cTBS to A1	Behavioral: Adaptation; Sensorimotor adaptation in speech; Other: cTBS; continuous theta-burst stimulation
Experimental: Adaptation to Altered Sensory Feedback + cTBS to M1 Adaptation to Altered Sensory Feedback + cTBS to M1	Behavioral: Adaptation; Sensorimotor adaptation in speech; Other: cTBS; continuous theta-burst stimulation
Experimental: Adaptation to Altered Sensory Feedback + Sham cTBS Adaptation to Altered Sensory Feedback + Sham cTBS	Behavioral: Adaptation; Sensorimotor adaptation in speech; Other: cTBS; continuous theta-burst stimulation

Outcome Measures

Primary Outcome Measures

1. Motor Learning [Performance as measured at the end of learning (30 minute session)]

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

2. Retention of Learning [24 hours after learning (re-test lasts 30 minutes)]

   Retention is measured on a 0 to 100 scale relative to the end of learning.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• right handed adults

• no known physical or neurological abnormalities

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McGill Univeristy	Montréal	Quebec	Canada	H3A1G1

Sponsors and Collaborators

• Yale University
• McGill University
• National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

• Principal Investigator: David Ostry, Haskins Laboratories

Study Documents (Full-Text)

• Informed Consent Form - Jul 31, 2019

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT04497428
• Other Study ID Numbers: 2000025475; R01DC017439
• First Posted: Aug 4, 2020
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 18, 2022