Assessing the Stability of Transcranial Magnetic Stimulation Plasticity Responses

NCT03034629 | Completed

• 1 other identifier: 20161183
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this proposed study is to assess the reliability of plasticity measured by transcranial magnetic stimulation (TMS) interleaved with intermittent theta-burst stimulation plasticity measures and to assess the influence of an acute bout of aerobic exercise on TMS plasticity measures.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in cortical synaptic plasticity

  As measured via Transcranial Magnetic Stimulation (TMS) in mean motor evoked potential (MEP) amplitude

  Baseline, 1 week

Secondary Outcomes (1)

• Assess TMS plasticity measures on healthy individuals after an acute bout of exercise

  Baseline, 3 weeks

Study Arms (1)

Short-term aerobic exercise

EXPERIMENTAL

One bout of moderate intensity exercise (75% of maximal predicated heart rate).

Behavioral: Short-term aerobic exercise

Interventions

Short-term aerobic exercise BEHAVIORAL

One bout of moderate intensity exercise (75% of maximal predicated heart rate).

Short-term aerobic exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females aged 18-70 years old.
• Primary language is English
• Exercise clearance

You may not qualify if:

• Presence of cognitive, neurologic or orthopedic conditions that could affect performance of the testing and training procedures
• History of migraines
• History of fainting spells of unknown or undetermined etiology that might constitute seizures
• History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or family history of treatment resistance epilepsy
• Any current history of psychiatric illness
• Any unstable medical condition
• The subject's past medical history, drug does, history of recent medication changes or duration of treatment, and combination with other central nervous system active drugs.
• The published TMS guidelines review medications to considered with TMS (Rossi, Hallet, Rossini, Pascual-Leone, \& Safety of TMS Consensus Group, 2009)
• Any metal in the brain, skull or elsewhere unless approved by the responsible MD
• Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator)
• Intracranial lesion
• Substance abuse or dependence within the past six months

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Study Officials

• Joyce R Gomes-Osman, PT, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 27, 2017
• Study Start: May 22, 2017
• Primary Completion: March 3, 2021
• Study Completion: September 27, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)