- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07455461
Cortical Excitability During de Novo Motor Learning (StimNovoLearn)
Cortical Excitability During de Novo Motor Learning in Healthy Subjects : an Exploratory Longitudinal Study
De novo motor learning is a specific learning paradigm that allows investigation of how a new motor skill is learned from scratch. Motor task learning can induce increased corticospinal excitability and reorganization of connectivity observed within the motor cortex (M1). Several studies have investigated the plasticity mechanisms underlying motor learning using simple paradigms. The results obtained have been variable, with a major trend toward increased corticospinal excitability, while other results show no increase. We expect to observe a significant increase in excitability and enhanced intracortical reorganization mechanisms within M1 in our subjects during our de novo motor learning sessions.
The primary objective of this study is to measure changes in corticospinal excitability of the motor system across 3 de novo motor learning sessions separated by different time intervals.
The secondary objectives will be: 1) to measure learning across the three practice sessions, 2) to measure changes in inhibition and facilitation across the 3 learning sessions, and 3) to measure correlations between subjects' motor performance and corticospinal and intracortical changes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pierre D Morel, Dr
- Phone Number: 0033781692692
- Email: pierre.morel@univ-littoral.fr
Study Locations
-
-
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Loos, France, 59120
- Recruiting
- Eurasport
-
Contact:
- Pierre D Morel, Doctor
- Phone Number: 0033781692692
- Email: pierre.morel@univ-littoral.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- right-handed
- healthy
- having signed an informed consent form
Exclusion Criteria:
- counter-indication to transcranial magnetic stimulation
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motor learning
Subjects follow a de novo motor learning protocol
|
Subjects will follow 3 sessions of de-novo motor learning (days 1, 2, 8)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Motor Evoked Potential (MEP) Amplitude Input-Output Curve Assessed by Single-Pulse TMS
Time Frame: Baseline (Day 1, pre-session), immediately post-session on Day 1, pre-session on Day 2, immediately post-session on Day 2, pre-session on Day 9, and immediately post-session on Day 9
|
Motor Evoked Potential amplitude (mV) recorded from the target muscle (Abductor Pollicis Brevis) in response to increasing TMS intensities.
The parameters of the sigmoid input-output curve will be calculated using a Boltzmann function fit.
|
Baseline (Day 1, pre-session), immediately post-session on Day 1, pre-session on Day 2, immediately post-session on Day 2, pre-session on Day 9, and immediately post-session on Day 9
|
|
Change in Short-Interval Intracortical Inhibition (SICI) Assessed by Paired-Pulse TMS
Time Frame: Baseline (Day 1, pre-session), immediately post-session on Day 1, pre-session on Day 2, immediately post-session on Day 2, pre-session on Day 9, and immediately post-session on Day 9
|
Conditioned MEP amplitude expressed as a ratio of unconditioned MEP amplitude (%), using a conditioning stimulus at 80% RMT and inter-stimulus interval of 3 ms.
|
Baseline (Day 1, pre-session), immediately post-session on Day 1, pre-session on Day 2, immediately post-session on Day 2, pre-session on Day 9, and immediately post-session on Day 9
|
|
Change in Long-Interval Intracortical Inhibition (LICI) Assessed by Paired-Pulse TMS
Time Frame: Baseline (Day 1, pre-session), immediately post-session on Day 1, pre-session on Day 2, immediately post-session on Day 2, pre-session on Day 9, and immediately post-session on Day 9
|
Conditioned MEP amplitude as a ratio of unconditioned MEP amplitude (%), using a conditioning stimulus at suprathreshold intensity and inter-stimulus interval of 100ms.
|
Baseline (Day 1, pre-session), immediately post-session on Day 1, pre-session on Day 2, immediately post-session on Day 2, pre-session on Day 9, and immediately post-session on Day 9
|
|
Change in Intracortical Facilitation (ICF) Assessed by Paired-Pulse TMS
Time Frame: Baseline (Day 1, pre-session), immediately post-session on Day 1, pre-session on Day 2, immediately post-session on Day 2, pre-session on Day 9, and immediately post-session on Day 9
|
Conditioned MEP amplitude as a ratio of unconditioned MEP amplitude (%), using a conditioning stimulus at 80% RMT and an inter-stimulus interval of 10ms.
|
Baseline (Day 1, pre-session), immediately post-session on Day 1, pre-session on Day 2, immediately post-session on Day 2, pre-session on Day 9, and immediately post-session on Day 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Motor Learning Performance Assessed by Movement Path Length During a 3D Finger-Cursor Task
Time Frame: During each motor learning session on Day 1, Day 2, and Day 9
|
Path length (mm) of the cursor trajectory during each trial of the motor learning task.
Shorter path length indicates more efficient, learned movement.
|
During each motor learning session on Day 1, Day 2, and Day 9
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023-A02139-36
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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