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

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

Sponsors

Lead Sponsor: University Hospital, Toulouse

Source University Hospital, Toulouse
Brief Summary

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.

Overall Status Completed
Start Date October 2010
Completion Date June 2012
Primary Completion Date June 2012
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change of subjective pain threshold determined using thermal stimulation (Thermotest) with the method of levels after rTMS session D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Secondary Outcome
Measure Time Frame
Analgesic effect of Repetitive Transcranial Magnetic Stimulation using Visual Analogue Scale 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) D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Mood assessment using Visual Analogue Scale D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Enrollment 30
Condition
Intervention

Intervention Type: Device

Intervention Name: Repetitive Transcranial Magnetic Stimulation

Description: 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

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

Gender: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Christine Brefel-Courbon, MD Principal Investigator Toulouse Hospital
Location
Facility: Purpan Hospital
Location Countries

France

Verification Date

June 2013

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: healthy volunteers

Type: Other

Description: All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation

Label: painful Parkinson's disease patients

Type: Other

Description: All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation

Label: painless Parkinson's disease patients

Type: Other

Description: All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation

Acronym rTMS
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov