Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability

NCT03739489 | Unknown DMC

• 1 other identifier: RG-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Rate Variability

Keywords

healthy subjects; repetitive transcranial magnetic stimulation; heart rate variability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Conditioned Pain Modulation

  48 hours before the first session of stimulation

• Volume in

  1 week before the first session of stimulation

Study Arms (3)

rTMS-PSI

ACTIVE COMPARATOR

Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the posterior superior insula right.

Procedure: Repetitive transcranial magnetic stimulation

rTMS-M1

ACTIVE COMPARATOR

Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the right primary motor cortex.

Procedure: Repetitive transcranial magnetic stimulation

rTMS-F3

ACTIVE COMPARATOR

Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the left pre frontal dorsolateral cortex.

Procedure: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation PROCEDURE

Repetitive transcranial magnetic stimulation was a technique able to modulate the brain circuit restoring the function.

rTMS-F3; rTMS-M1; rTMS-PSI

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Agreed participate the protocol
• Signing the consent form
• Do not present any cardiac problems or disease

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)

São Paulo, São Paulo, 05403900, Brazil

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor, Clinical Research

Model Details: The participant will be received three different sessions of rtms, with wash out 30 days between sessions.

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: November 13, 2018
• Study Start: April 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)