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Clinical Trials/NCT03504748
NCT03504748
Unknown
N/A

Deep rTMS in Parkinson Disease Pain Syndromes

University of Sao Paulo1 site in 1 country30 target enrollmentJuly 20, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain
Sponsor
University of Sao Paulo
Enrollment
30
Locations
1
Primary Endpoint
Change in baseline of Pain
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2015
End Date
December 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel Ciampi Araujo de Andrade, MD, PhD

MD, PhD (Head of Pain Division)

University of Sao Paulo

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in baseline of Pain

Time Frame: 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.

Study Sites (1)

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