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

NCT ID: NCT03304262

Last Updated: 2023-08-25

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-18

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a randomized, sham-controlled, double blinded crossover trial.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators
Participants will be blinded to treatment group, investigator administering tDCS will be blinded to which treatment arm subject is assigned to, and the data analyst will be conducting analysis off site and is different than investigator applying stimulation.

Study Groups

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

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.

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type DEVICE

Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.

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

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.

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type DEVICE

Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.

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

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.

Group Type SHAM_COMPARATOR

rTMS

Intervention Type DEVICE

Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.

Interventions

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rTMS

Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.

Intervention Type DEVICE

Other Intervention Names

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rapid transcranial magnetic stimulation

Eligibility Criteria

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Inclusion Criteria

* Must be at least 18 years of age (all genders, races, ethnicity)
* Must have no current psychiatric or neurologic issues

Exclusion Criteria

* Must be fluent in English


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Sarah Pirio Richardson

Assistant Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Pirio Richardson, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Davin Quinn, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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16-410

Identifier Type: -

Identifier Source: org_study_id

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