Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Pain Perception in Parkinson’s Disease

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
  • Study Primary Completion Date: June 2012

Interventions Used in this Clinical Trial

  • Device: Repetitive Transcranial Magnetic 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Other: healthy volunteers
    • All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
  • Other: painful Parkinson’s disease patients
    • All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
  • Other: painless Parkinson’s disease patients
    • All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation

Outcome Measures for this Clinical Trial

Primary Measures

  • 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
      Safety Issue?: Yes

Secondary Measures

  • Analgesic effect of Repetitive Transcranial Magnetic Stimulation using Visual Analogue Scale
    • Time Frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
      Safety Issue?: Yes
  • - 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
      Safety Issue?: Yes
  • Mood assessment using Visual Analogue Scale
    • Time Frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • University Hospital, Toulouse
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christine Brefel-Courbon, MD, Principal Investigator, Toulouse Hospital

Source

Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01275573