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

August 23, 2023 updated by: Sarah Pirio Richardson, University of New Mexico

Metaplasticity in the Human Motor Cortex: Validation of an Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: rTMS
Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
Other Names:
  • rapid transcranial magnetic stimulation
Active Comparator: 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.
Device: rTMS
Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
Other Names:
  • rapid transcranial magnetic stimulation
Sham Comparator: 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.
Device: rTMS
Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
Other Names:
  • rapid transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in MEP Amplitude
Time Frame: 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
assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortical Silent Period
Time Frame: tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)
Change in length of CSP
tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)
Simple Reaction Time
Time Frame: 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.
The final outcome will be percent change in the reaction time from pre- to post- intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Investigators

  • Principal Investigator: Sarah Pirio Richardson, M.D., University of New Mexico
  • Principal Investigator: Davin Quinn, M.D., University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2017

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

September 21, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 6, 2017

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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