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

NCT03304262 | Completed Results FDA Device

• 1 other identifier: 16-410
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Metaplasticity; Motor excitability; rTMS; tDCS

Outcome Measures

Primary Outcomes (1)

• Percent Change in MEP Amplitude

  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 Outcomes (2)

• Cortical Silent Period

  tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)

• Simple Reaction Time

  The final outcome will be percent change in the reaction time from pre- to post- intervention.

Study Arms (3)

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

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

SHAM COMPARATOR

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

Interventions

rTMS DEVICE

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

Also known as: rapid transcranial magnetic stimulation

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Results Point of Contact

• Title: Sarah Pirio Richardson
• Organization: University of New Mexico

spiriorichardson@salud.unm.edu

505-272-3342

Study Officials

• Sarah Pirio Richardson, M.D.

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Davin Quinn, M.D.

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Model Details: This is a randomized, sham-controlled, double blinded crossover trial.

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 6, 2017
• Study Start: July 18, 2017
• Primary Completion: February 28, 2018
• Study Completion: March 31, 2018
• Last Updated: August 25, 2023
• Results First Posted: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)