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

November 9, 2018 updated by: Ricardo Galhardoni, University of Sao Paulo
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403900
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
48 hours before the first session of stimulation
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
1 week before the first session of stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (ACTUAL)

November 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2018

Last Update Submitted That Met QC Criteria

November 9, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RG-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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