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Assessing the Stability of Transcranial Magnetic Stimulation Plasticity Responses

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ClinicalTrials.gov Identifier: NCT03034629
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Joyce Rios Gomes Osman, University of Miami

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.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Short-term aerobic exercise Not Applicable

Detailed Description:
The primary aim of this study is to assess the reliability of TMS plasticity measures recorded one week apart, on healthy individuals. The secondary aim is assess TMS plasticity measures on healthy individuals after an acute bout of aerobic exercise. Participants will complete 3 visits. Visits 1 and 2 comprise TMS plasticity testing, and on visit 3, participants will complete a short bout of aerobic exercise before undergoing TMS plasticity testing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessing the Reliability and Influence of Timing of Exercise on Transcranial Magnetic Stimulation (TMS) Neuroplasticity Measures
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Short-term aerobic exercise
One bout of moderate intensity exercise (75% of maximal predicated heart rate).
Behavioral: Short-term aerobic exercise
One bout of moderate intensity exercise (75% of maximal predicated heart rate).




Primary Outcome Measures :
  1. Change in cortical synaptic plasticity using transcranial magnetic stimulation (TMS) to establish reliability. [ Time Frame: Baseline and after week 1 ]
    Visits 1 and 2 comprise TMS plasticity testing (no intervention).


Secondary Outcome Measures :
  1. Change in cortical synaptic plasticity using transcranial magnetic stimulation (TMS) to assess effects of short-term exercise. [ Time Frame: Baseline and after Week 3 ]
    On visit 3, participants will complete a short bout of aerobic exercise before undergoing TMS plasticity testing.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034629


Contacts
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Contact: Joyce R Gomes-Osman 305-284-2632 j.gomes@miami.edu

Locations
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United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Joyce Gomes-Osman    305-284-2632      
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Joyce R Gomes-Osman, PT, PhD University of Miami

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Responsible Party: Joyce Rios Gomes Osman, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03034629     History of Changes
Other Study ID Numbers: 20161183
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No