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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01275573
First received: December 10, 2010
Last updated: June 18, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
 Device: Repetitive Transcranial Magnetic Stimulation
 Phase 2

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
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]
    Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)


Secondary Outcome Measures:
  • Analgesic effect of Repetitive Transcranial Magnetic Stimulation using Visual Analogue Scale [ Time Frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn ] [ Designated as safety issue: Yes ]
    Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)

  • - 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 ] [ Designated as safety issue: Yes ]
    Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)

  • Mood assessment using Visual Analogue Scale [ Time Frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn ] [ Designated as safety issue: Yes ]
    Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
Enrollment: 30
Study Start Date: October 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
healthy volunteers
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
 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.
Other Name: non applicable
painful Parkinson's disease patients
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
 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.
Other Name: non applicable
painless Parkinson's disease patients
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
 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.
Other Name: non applicable

  Eligibility
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275573

Locations
France
Purpan Hospital
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Christine Brefel-Courbon, MD Toulouse Hospital
  More Information

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01275573     History of Changes
Other Study ID Numbers: 09 155 02 
Study First Received: December 10, 2010
Last Updated: June 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Repetitive Transcranial Magnetic Stimulation
pain threshold
Parkinson's disease
Pain threshold in Parkinson's disease

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

ClinicalTrials.gov processed this record on September 28, 2016