NCT03304262

Metaplasticity Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change

Completed NA Results posted Last updated 25 August 2023

What this trial tests

NA trial testing rTMS in Healthy in 13 participants. Completed in 31 March 2018.

Timeline

18 July 2017

Primary endpoint
28 February 2018

31 March 2018

Quick facts

Lead sponsor	University of New Mexico
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	diagnostic
Enrollment	13
Start date	18 July 2017
Primary completion	28 February 2018
Estimated completion	31 March 2018
Sites	1 location across United States

Drugs / interventions tested

• rTMS

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

University of New Mexico

Who can join

Adults 18 to 99, female only, with Healthy. 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.

Percent Change in MEP Amplitude Primary · assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes

Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand

Group	Value	95% CI
Cathodal tDCS + rTMS	1.19	0.43 – 5.65
Anodal tDCS + rTMS	1.06	0.33 – 2.03
Sham tDCS + rTMS	1.38	0.19 – 2.82

Cortical Silent Period Secondary · tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)

Change in length of CSP

Group	Value	95% CI
Cathodal tDCS + rTMS	1.02	0.88 – 1.23
Anodal tDCS + rTMS	1.01	0.88 – 1.13
Sham tDCS + rTMS	0.99	.88 – 1.08

Simple Reaction Time Secondary · The final outcome will be percent change in the reaction time from pre- to post- intervention.

Participants will perform a simple reaction time task. This will be measured in seconds of response after a stimulus. The final outcome will be percent change in the reaction time from pre- to post- intervention.

Group	Value	95% CI
Cathodal tDCS + rTMS	1.01	0.94 – 1.15
Anodal tDCS + rTMS	1.02	0.91 – 1.19
Sham tDCS + rTMS	1.02	0.9 – 1.16

Sponsor's own description

The overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in healthy human participants.

Publications & conference data

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