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Deep rTMS in Parkinson Disease Pain Syndromes

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ClinicalTrials.gov Identifier: NCT03504748
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Ciampi Araujo de Andrade, MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Pain Parkinson Disease Device: deep rTMS Device: placebo deep rTMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep rTMS in Parkinson Disease Pain Syndromes
Actual Study Start Date : July 20, 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504748


Contacts
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Contact: Daniel MD Ciampi, Phd + 55 11 997753538 ciampi@usp.br
Contact: Victor MD Barboza, PhD student + 55 11 997017706 victors.rb@gmail.com

Locations
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Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP) Recruiting
São Paulo, SP, Brazil, 05403900
Contact: Daniel MD Ciampi, Phd    + 55 11 997753538    ciampi@usp.br   
Sponsors and Collaborators
University of Sao Paulo

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Responsible Party: Daniel Ciampi Araujo de Andrade, MD, PhD, MD, PhD (Head of Pain Division), University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03504748     History of Changes
Other Study ID Numbers: VRBDCA
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by Daniel Ciampi Araujo de Andrade, MD, PhD, University of Sao Paulo:
deep repetitive transcranial magnetic stimulation
chronic pain
parkinson
treatment
non-motor symptom

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases