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

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rTMS
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy focused on measuring Metaplasticity, Motor excitability, rTMS, tDCS

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • University of New Mexico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

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

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

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

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cortical Silent Period
Change in length of CSP
Simple Reaction Time
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.

Full Information

First Posted
September 21, 2017
Last Updated
August 23, 2023
Sponsor
University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT03304262
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Metaplasticity, Motor excitability, rTMS, tDCS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a randomized, sham-controlled, double blinded crossover trial.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cathodal tDCS + rTMS then Anodal tDCS + rTMS then Sham tDCS + rTMS
Arm Type
Active Comparator
Arm 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.
Arm Title
Anodal tDCS + rTMS then Sham tDCS + rTMS then Cathodal tDCS + rTMS
Arm Type
Active Comparator
Arm 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.
Arm Title
Sham tDCS + rTMS then Cathodal tDCS + rTMS then Anodal tDCS + rTMS
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
rTMS
Other Intervention Name(s)
rapid transcranial magnetic stimulation
Intervention Description
Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
Primary Outcome Measure Information:
Title
Percent Change in MEP Amplitude
Description
Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand
Time Frame
assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes
Secondary Outcome Measure Information:
Title
Cortical Silent Period
Description
Change in length of CSP
Time Frame
tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)
Title
Simple Reaction Time
Description
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.
Time Frame
The final outcome will be percent change in the reaction time from pre- to post- intervention.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Pirio Richardson, M.D.
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Davin Quinn, M.D.
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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