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Deep rTMS in Parkinson Disease Pain Syndromes

Primary Purpose

Pain, Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
deep rTMS
placebo deep rTMS
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring deep repetitive transcranial magnetic stimulation, chronic pain, parkinson, treatment, non-motor symptom

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

deep rTMS-active doble coil

deep rTMS-sham

Arm Description

patients undergoing of deep rTMS real with doble coil

patients undergoing to placebo deep rTMS

Outcomes

Primary Outcome Measures

Change in baseline of Pain
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.

Secondary Outcome Measures

Full Information

First Posted
April 12, 2018
Last Updated
May 2, 2018
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03504748
Brief Title
Deep rTMS in Parkinson Disease Pain Syndromes
Official Title
Deep rTMS in Parkinson Disease Pain Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2015 (Actual)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Parkinson Disease
Keywords
deep repetitive transcranial magnetic stimulation, chronic pain, parkinson, treatment, non-motor symptom

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
deep rTMS-active doble coil
Arm Type
Active Comparator
Arm Description
patients undergoing of deep rTMS real with doble coil
Arm Title
deep rTMS-sham
Arm Type
Sham Comparator
Arm Description
patients undergoing to placebo deep rTMS
Intervention Type
Device
Intervention Name(s)
deep rTMS
Intervention Type
Device
Intervention Name(s)
placebo deep rTMS
Primary Outcome Measure Information:
Title
Change in baseline of Pain
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel MD Ciampi, Phd
Phone
+ 55 11 997753538
Email
ciampi@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Victor MD Barboza, PhD student
Phone
+ 55 11 997017706
Email
victors.rb@gmail.com
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel MD Ciampi, Phd
Phone
+ 55 11 997753538
Email
ciampi@usp.br

12. IPD Sharing Statement

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Deep rTMS in Parkinson Disease Pain Syndromes

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