Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Pain Perception in Parkinson's Disease (rTMS)

June 18, 2013 updated by: University Hospital, Toulouse

High Frequency rTMS (Repetitive Transcranial Magnetic Stimulation) Effect Applied on Primary Cortical Motor, on Nociceptive Perception Thresholds in Parkinson's Disease Patients: a Physiopathology Study

Pain is a frequent symptom in Parkinson's disease. Previous studies have shown that pain perception was altered in Parkinson's disease patients and could be related to nociceptive cortical area hyperactivation. Repetitive Transcranial Magnetic Stimulation is an electrophysiological tool which can modify cortical excitability. Its efficacy was demonstrated in neuropathic pain. This is a randomized, double blind cross-over study. In this study, subjective pain threshold (using thermal stimulation (Thermotest)).will be evaluated in 3 groups of subjects: healthy volunteers, painful Parkinson's patients and pain free Parkinson's disease patients. Each group will receive a high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation in different order with a gap of one week.

The investigators supposed that a 20 Hz Repetitive Transcranial Magnetic Stimulation session with an infraliminary intensity on the primary cortical motor, modulating nociceptive cortical areas activity, could modify the nociceptive threshold perception in Parkinson's patients.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

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

      • Toulouse, France, 31000
        • Purpan Hospital

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

For patients:

  • Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB
  • Parkinson's disease patients with a score≤3 on the Hoehn and Year scale
  • Patients treated with dopaminergic antiparkinsonian drugs (L-DOPA, dopamine agonists,ICOMT…)
  • Patients with or without neuropathic pain induced by Parkinson's disease
  • Patients without personal or familial epilepsy episode history
  • Patients from 50 to 80 years old (male or female)
  • Patients affiliated to a social protection program
  • Patient with an informed consent given

For Healthy volunteers

  • Subjects from 50 to 80 years old (male or female)
  • Subjects without any serious evolutionary pathology or any clinical significant treatment
  • Subjects without chronic pain or disease which can induce neuropathic pain
  • Subjects without personal or familial epilepsy episode history
  • Subjects affiliated to a social protection program
  • Subjects with an informed consent given

Exclusion Criteria:

For patients:

  • Patients suffering from an other pathology causing chronic pain (rheumatic disease, traumatic or orthopaedic pathologies…)
  • Parkinson's disease patients with a score>3 on the Hoehn and Yahr scale
  • Patients with important tremors during a OFF conditions
  • Patients suffering from a cancer
  • Patients with a neuroleptic treatment
  • Patients under tutelage, curatella or law protection
  • Patients included in an other clinical study
  • Patients unable to fulfil scales of the study
  • Patients with personal or familial epilepsy episode history
  • Contraindication of IRM
  • Pregnant women

For Healthy volunteers:

  • Subjects with serious evolutionary pathology or any clinical significant treatment
  • Subjects with chronic pain or disease which can induce neuropathic pain
  • Subjects with personal or familial epilepsy episode history
  • Contraindication of IRM
  • Pregnant women
  • Subjects under tutelage, curatella or law protection
  • Subjects included in an other clinical study

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: healthy volunteers
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
Repetitive Transcranial Magnetic Stimulation will be applied on the contralateral primary cortical motor on the painful side for the Parkinson's disease patients and on the left primary cortical motor for the healthy volunteer. The stimulation frequency will be 20 Hz during 26 min with an intensity stimulation equal of 95% of the motor threshold.
Other Names:
  • non applicable
Other: painful Parkinson's disease patients
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
Repetitive Transcranial Magnetic Stimulation will be applied on the contralateral primary cortical motor on the painful side for the Parkinson's disease patients and on the left primary cortical motor for the healthy volunteer. The stimulation frequency will be 20 Hz during 26 min with an intensity stimulation equal of 95% of the motor threshold.
Other Names:
  • non applicable
Other: painless Parkinson's disease patients
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
Repetitive Transcranial Magnetic Stimulation will be applied on the contralateral primary cortical motor on the painful side for the Parkinson's disease patients and on the left primary cortical motor for the healthy volunteer. The stimulation frequency will be 20 Hz during 26 min with an intensity stimulation equal of 95% of the motor threshold.
Other Names:
  • non applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of subjective pain threshold determined using thermal stimulation (Thermotest) with the method of levels after rTMS session
Time Frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic effect of Repetitive Transcranial Magnetic Stimulation using Visual Analogue Scale
Time Frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
- Clinical evaluation of the severity of the motor handicap of patients using Unified's Parkinson's Disease Rating Scale (UPDRSIII)
Time Frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Mood assessment using Visual Analogue Scale
Time Frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Christine Brefel-Courbon, MD, Toulouse Hospital

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

October 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 10, 2010

First Submitted That Met QC Criteria

January 11, 2011

First Posted (Estimate)

January 12, 2011

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

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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