Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability

Study Overview
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Brief Summary
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Repetitive transcranial magnetic stimulation is a non-invasive neuromodulation technique used to treat different neuropsychiatric disorders, such as, depression, neuropathic pain, fibromyalgia and obsessive-compulsive disorder. It is known that the heart rate variability is altered in these conditions. Therefore the focus of this research is to show the influence of rTMS on the Heart Rate Variability.

Official Title
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Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability

Conditions
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Heart Rate Variability

Intervention / Treatment
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* Procedure: Repetitive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Agreed participate the protocol Signing the consent form Do not present any cardiac problems or disease Exclusion Criteria: Trauma of Skull, epilepsy don't treated, Use of medications decrease the seizure threshold Patients in use of drugs, how cocaine and alcohol Neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure) Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The participant will be received three different sessions of rtms, with wash out 30 days between sessions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rTMS-PSI<br>Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the posterior superior insula right. | Procedure: Repetitive transcranial magnetic stimulation<br>* Repetitive transcranial magnetic stimulation was a technique able to modulate the brain circuit restoring the function.<br>|
| Active Comparator: rTMS-M1<br>Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the right primary motor cortex. | Procedure: Repetitive transcranial magnetic stimulation<br>* Repetitive transcranial magnetic stimulation was a technique able to modulate the brain circuit restoring the function.<br>|
| Active Comparator: rTMS-F3<br>Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the left pre frontal dorsolateral cortex. | Procedure: Repetitive transcranial magnetic stimulation<br>* Repetitive transcranial magnetic stimulation was a technique able to modulate the brain circuit restoring the function.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability changes | Changes in heart rate variability measured by Polar V800 | Three times during the entire study. Following the scheme, Until 1 hour before each session, 15 minutes along the each session and until 1 hour after the end of session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conditioned Pain Modulation | change in pain units on a scale of 0-100. 0 no pain. 100 = the maximum pain | 48 hours before the first session of stimulation | 
| Volume in | Determine if volume cortical regions can serve as biomarkers to predict rTMS treatment response in Healthy volunteers | 1 week before the first session of stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy subjects, repetitive transcranial magnetic stimulation, heart rate variability