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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304262
• Other study ID #: 16-410
• Status: Completed
• Phase: N/A
• Start date: July 18, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: August 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 31, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Hypersensitivity

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cortical Silent Period	Change in length of CSP	tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)
Secondary	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.	The final outcome will be percent change in the reaction time from pre- to post- intervention.