Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability

Heart Rate Variability Clinical Trial

— TMSXHRV  

Official title:

Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03739489
• Other study ID #: RG-02
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 2018

Study information

• Verified date: November 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Rate Variability

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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