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

University of New Mexico (UNM)

Status: Completed

Conditions: Healthy

Treatments: Device: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03304262

16-410

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 3 patient groups

Cathodal tDCS + rTMS then Anodal tDCS + rTMS then Sham tDCS + rTMS

Active Comparator group

Description:

Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.

Treatment:

Device: rTMS

Anodal tDCS + rTMS then Sham tDCS + rTMS then Cathodal tDCS + rTMS

Active Comparator group

Description:

Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.

Treatment:

Device: rTMS

Sham tDCS + rTMS then Cathodal tDCS + rTMS then Anodal tDCS + rTMS

Sham Comparator group

Description:

Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.

Treatment:

Device: rTMS