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Completed

NCT Number: NCT03304262

Metaplasticity 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.

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Key information

Conditions

Healthy

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: rapid transcranial magnetic stimulation

Primary outcomes

  1. 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

Secondary outcomes

  1. Cortical Silent Period

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

    Change in length of CSP

  2. 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.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 6, 2017
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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