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

NCT ID: NCT01275573

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-06-30

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

healthy volunteers

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

Group Type: OTHER

Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

painful Parkinson's disease patients

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

Group Type: OTHER

Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

painless Parkinson's disease patients

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

Group Type: OTHER

Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Brefel-Courbon, MD

Role: PRINCIPAL_INVESTIGATOR

Toulouse Hospital

Locations

Purpan Hospital

Toulouse, , France

Countries

France

Other Identifiers

09 155 02

Identifier Type: -

Identifier Source: org_study_id