Deep rTMS in Parkinson Disease Pain Syndromes

Not Applicable

• Conditions: Parkinson Disease; Pain
• Interventions: Device: deep rTMS; Device: placebo deep rTMS

• Registration Number: NCT03504748
• Lead Sponsor: University of Sao Paulo

Brief Summary

Pain is the most prevalent non-motor symptom in Parkinson disease, and the motor improvement not always is related to the pain improvement with the medication treatment. By this, we are testing a non-invasive method called transcranial magnetic stimulation as an alternative to treat pain related to Parkinson disease. This technique can lead to either inhibitory or excitatory effects in brain circuits depending on stimulation parameters, and is known to provide analgesic effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-20
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-20
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-08
• Primary Completion: 2018-07
• Study Completion: 2018-12

Recruitment & Eligibility

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

Inclusion Criteria

• Parkinson disease
• Signed term of informed consent
• Parkinsson disease related pain

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 lacting women
• Moderate or severe cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
deep rTMS-active doble coil	deep rTMS	patients undergoing of deep rTMS real with doble coil
deep rTMS-sham	placebo deep rTMS	patients undergoing to placebo deep rTMS

Primary Outcome Measures

Name	Time	Method
Change in baseline of Pain	base line (moment of inclusion), day 15th, day 45th and in the last day of the sessions of rTMS (4X in two months)	assessing by Visual Analog Scale for Pain (VAS). This scale range from 0 (no pain) to 10 (maximum pain), being considered an effective improvement in the patient's pain when the pain decreases at least in 30% from the basal score.

Trial Locations

Locations (1)

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