Deep rTMS in Parkinson Disease Pain Syndromes

May 2, 2018 updated by: Daniel Ciampi Araujo de Andrade, MD, PhD, University of Sao Paulo
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403900
        • Recruiting
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)
        • Contact:
          • Daniel MD Ciampi, Phd
          • Phone Number: + 55 11 997753538
          • Email: ciampi@usp.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: deep rTMS-active doble coil
patients undergoing of deep rTMS real with doble coil
Device: deep rTMS
Sham Comparator: deep rTMS-sham
patients undergoing to placebo deep rTMS
Device: placebo deep rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
base line (moment of inclusion), day 15th, day 45th and in the last day of the sessions of rTMS (4X in two months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRBDCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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