Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability

Not Applicable

• Conditions: Heart Rate Variability
• Interventions: Procedure: Repetitive transcranial magnetic stimulation

• Registration Number: NCT03739489
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-28
• Study Start: 2018-04-01
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-09
• Last Update Submitted: 2018-11-09
• Study First Posted: 2018-11-13
• Last Update Posted: 2018-11-13
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
rTMS-M1	Repetitive transcranial magnetic stimulation	Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the right primary motor cortex.
rTMS-F3	Repetitive transcranial magnetic stimulation	Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the left pre frontal dorsolateral cortex.
rTMS-PSI	Repetitive transcranial magnetic stimulation	Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the posterior superior insula right.

Primary Outcome Measures

Name	Time	Method
Heart rate variability changes	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

Name	Time	Method
Volume in	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
Conditioned Pain Modulation	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

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP); 🇧🇷 São Paulo, SP, Brazil