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Trial record 9 of 1366 for:    transcranial magnetic stimulation

Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability (TMSXHRV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03739489
Recruitment Status : Enrolling by invitation
First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ricardo Galhardoni, University of Sao Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Rate Variability Procedure: Repetitive transcranial magnetic stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The participant will be received three different sessions of rtms, with wash out 30 days between sessions.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: rTMS-PSI
Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the posterior superior insula right.
Procedure: Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation was a technique able to modulate the brain circuit restoring the function.

Active Comparator: rTMS-M1
Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the right primary motor cortex.
Procedure: Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation was a technique able to modulate the brain circuit restoring the function.

Active Comparator: rTMS-F3
Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the left pre frontal dorsolateral cortex.
Procedure: Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation was a technique able to modulate the brain circuit restoring the function.




Primary Outcome Measures :
  1. Heart rate variability changes [ Time Frame: 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 ]
    Changes in heart rate variability measured by Polar V800


Secondary Outcome Measures :
  1. Conditioned Pain Modulation [ Time Frame: 48 hours before the first session of stimulation ]
    change in pain units on a scale of 0-100. 0 no pain. 100 = the maximum pain

  2. Volume in [ Time Frame: 1 week before the first session of stimulation ]
    Determine if volume cortical regions can serve as biomarkers to predict rTMS treatment response in Healthy volunteers



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03739489


Locations
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Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)
São Paulo, SP, Brazil, 05403900
Sponsors and Collaborators
University of Sao Paulo

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Responsible Party: Ricardo Galhardoni, assistant professor, Clinical Research, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03739489     History of Changes
Other Study ID Numbers: RG-02
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
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

Keywords provided by Ricardo Galhardoni, University of Sao Paulo:
healthy subjects
repetitive transcranial magnetic stimulation
heart rate variability