HealthyNCT03034629
Assessing the Stability of Transcranial Magnetic Stimulation Plasticity Responses
A study testing Short-term aerobic exercise in people with Healthy, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Short-term aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 27 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult males and females aged 18-70 years old.
- Primary language is English
- Exercise clearance
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: Assessing the Reliability and Influence of Timing of Exercise on Transcranial Magnetic Stimulation (TMS) Neuroplasticity Measures
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
- Being tested
- Short-term aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-term aerobic exerciseBehavioural
One bout of moderate intensity exercise (75% of maximal predicated heart rate).
| Study group | Role | What they receive |
|---|---|---|
| Short-term aerobic exercise | Experimental | One bout of moderate intensity exercise (75% of maximal predicated heart rate). Receives: Behavioral: Short-term aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cortical synaptic plasticity
As measured via Transcranial Magnetic Stimulation (TMS) in mean motor evoked potential (MEP) amplitude
Measured: Baseline, 1 week
Secondary outcomes (1)
Assess TMS plasticity measures on healthy individuals after an acute bout of exercise
As measured via Transcranial Magnetic Stimulation (TMS) in mean motor evoked potential (MEP) amplitude after an acute bout of aerobic exercise
Measured: Baseline, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start22 May 2017
- Primary completion3 Mar 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joyce Rios Gomes Osman, University of Miami
- Investigators
- Joyce R Gomes-Osman, PT, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034629
- Sponsor's protocol ID
- 20161183
- Status last verified
- Nov 2021
- First submitted
- 16 Jan 2017
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Reliability and Influence of Timing of Exercise on Transcranial Magnetic Stimulation (TMS) Neuroplasticity Measures
- ClinicalTrials.gov ID
- NCT03034629
- Acronym / sponsor ID
- 20161183
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short-term aerobic exercise | Experimental | Behavioral: Short-term aerobic exerciseOne bout of moderate intensity exercise (75% of maximal predicated heart rate). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult males and females aged 18-70 years old.
- Primary language is English
- Exercise clearance
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-term aerobic exerciseOne bout of moderate intensity exercise (75% of maximal predicated heart rate). | Behavioural | Short-term aerobic exercise |
Primary outcome
Change in cortical synaptic plasticity
Time frame: Baseline, 1 week
As measured via Transcranial Magnetic Stimulation (TMS) in mean motor evoked potential (MEP) amplitude
1 secondary outcome
Assess TMS plasticity measures on healthy individuals after an acute bout of exercise
Time frame: Baseline, 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce R Gomes-Osman, PT, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-term aerobic exercise in people with Healthy, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cortical synaptic plasticity (time frame: Baseline, 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.