Clinical trial NCT03304262: Metaplasticity Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change
Official title: Metaplasticity in the Human Motor Cortex: Validation of an Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Metaplasticity
Motor excitability
rTMS
tDCS
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, sham-controlled, double blinded crossover trial.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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. Our primary objective is to compare pre- and post-measures of cortical excitability before priming tDCS (anodal, cathodal or sham) \[M1\], directly after priming tDCS \[M2\], directly after inhibitory rTMS \[M3\], and 10 minutes after inhibitory rTMS \[M4\]. Our secondary objective is to evaluate the sensitivity of motor excitability outcome measures response to the noninvasive neurostimulation (e.g. rTMS and tDCS). We also aim to compare pre- and post- measures of cortical excitability after inhibitory and excitatory priming of the motor cortex, and to evaluate the sensitivity of motor outcome measures to changes in cortical plasticity.

Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years of age (all genders, races, ethnicity)
* Must have no current psychiatric or neurologic issues
* Must not have any conditions listed in exclusion criteria
* Must be fluent in English

Exclusion Criteria:

* History of major psychiatric illness
* Actively using neuropsychoactive medication
* Legal or mental incompetency
* Substance use disorder, abuse or dependence, with active use within the last three months
* Significant medical or neurological illness
* Prior neurosurgical illness
* Prior neurosurgical procedure
* History of seizure
* History of ECT or TMS treatment within the past there months
* Presence of a pacemaker, implanted medical pump or device, metal plate, or metal object in skull or eye (including shunts, dental implants, facial tattoos with metallic ink)
* Pregnant women

Primary outcomes:
measure: Percent Change in MEP Amplitude
timeFrame: assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes
Secondary outcomes:
measure: Cortical Silent Period
timeFrame: tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)
measure: Simple Reaction Time
timeFrame: The final outcome will be percent change in the reaction time from pre- to post- intervention.
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Sarah Pirio Richardson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico
name: Davin Quinn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: