NCT04138953

Cortical Contributions to Motor Sequence Learning

Completed NA Results posted Last updated 28 August 2024

What this trial tests

NA trial testing Transcranial Magnetic Stimulation (TMS) in Brain Injuries in 64 participants. Completed in 4 August 2023.

Timeline

5 December 2019

Primary endpoint
4 August 2023

4 August 2023

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	64
Start date	5 December 2019
Primary completion	4 August 2023
Estimated completion	4 August 2023
Sites	2 locations across United States

Drugs / interventions tested

• Transcranial Magnetic Stimulation (TMS)
• Sham TMS

Conditions studied

• Brain Injuries — all drugs for Brain Injuries →

Sponsor

Emory University

Who can join

Adults 18 to 85, any sex, with Brain Injuries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Serial Reaction Time Task (SRTT) Performance Primary · Pre-test (baseline), Post-test (training usually lasts for 3 hours), Retention Test (30 mins following training)

The SRTT involves pressing a key that corresponds to a target square presented on a monitor. Sequenced skill (SS) is calculated by subtracting the response time of sequenced key presses from random key presses within and across a test block. An increase in SS value indicates an increase in sequenced skill and is a preferable result.

SS Pre-test

Group	Value	95% CI
Sham TMS	31	± 38
TMS Over Primary Motor Cortex (M1)	35	± 19
TMS Over Premotor Cortex (PMC)	38	± 24

SS Post-test

Group	Value	95% CI
Sham TMS	24	± 21
TMS Over Primary Motor Cortex (M1)	30	± 22
TMS Over Premotor Cortex (PMC)	17	± 23

SS Retention Testing

Group	Value	95% CI
Sham TMS	31	± 25
TMS Over Primary Motor Cortex (M1)	40	± 23
TMS Over Premotor Cortex (PMC)	29	± 11

Cortical Excitability Measured by Motor Evoked Potentials (MEPs) Secondary · Pre-test (baseline), Post-test (training usually lasts for 3 hours)

Evaluate the effect of sequence learning on motor cortical excitability. Cortical excitability will be indexed by peak-to-peak amplitudes of transcranial magnetic stimulation (TMS)-evoked electromyographic responses in the hand contralateral to the motor cortex targeted by TMS quantified before and after training. An increase in MEPs indicates neural plasticity due to increases in skill.

MEP Amplitude Pre-test

Group	Value	95% CI
Sham TMS	1.03	± 0.97
TMS Over Primary Motor Cortex (M1)	1.29	± 1.22
TMS Over Premotor Cortex (PMC)	0.45	± 0.37

MEP Amplitude Post-test

Group	Value	95% CI
Sham TMS	1.15	± 1.03
TMS Over Primary Motor Cortex (M1)	1.37	± 1.24
TMS Over Premotor Cortex (PMC)	0.51	± 0.53

Sponsor's own description

The long-term objective initiated with this study is to determine which brain areas functionally contribute to learning a motor skill. The primary hypothesis of this trial is that premotor cortex (PMC) is necessary to learn a new motor skill. Participants may undergo a MRI scan to acquire a structural image of their brain to target noninvasive stimulation, using transcranial magnetic stimulation (TMS) to one of two brain areas: PMC or primary motor cortex (M1). A third group of individuals will undergo a placebo stimulation protocol. For all three groups, stimulation will be used to create a transient 'virtual lesion' during motor skill training. Temporarily disrupting the normal activity of these brain regions during training will allow us to determine which regions are causally involved in learning a new motor skill. The primary outcome measure will be the change in skill after training in each group.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.