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Completed

NCT Number: NCT03034629

Assessing the Stability of Transcranial Magnetic Stimulation Plasticity Responses

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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
  • No medication is an absolute exclusion from TMS. Medications will be reviewed by the Principal Investigator and a decision about inclusion will be made based on the following:
  • 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

Treatment and study plan

Short-term aerobic exercise

Behavioral

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

Primary outcomes

  1. Change in cortical synaptic plasticity

    Time frame: Baseline, 1 week

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

Secondary outcomes

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

    Time frame: Baseline, 3 weeks

    As measured via Transcranial Magnetic Stimulation (TMS) in mean motor evoked potential (MEP) amplitude after an acute bout of aerobic exercise

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Assessing the Reliability and Influence of Timing of Exercise on Transcranial Magnetic Stimulation (TMS) Neuroplasticity Measures

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2017
Registry last updated
Dec 7, 2021

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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