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

Parkinson's Disease Clinical Trial

— rTMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275573
• Other study ID #: 09 155 02
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2010
• Last updated: June 18, 2013
• Start date: October 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2013
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
France	Purpan Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of subjective pain threshold determined using thermal stimulation (Thermotest) with the method of levels after rTMS session	Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)	D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn	Yes
Secondary	Analgesic effect of Repetitive Transcranial Magnetic Stimulation using Visual Analogue Scale	Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)	D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn	Yes
Secondary	- Clinical evaluation of the severity of the motor handicap of patients using Unified's Parkinson's Disease Rating Scale (UPDRSIII)	Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)	D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn	Yes
Secondary	Mood assessment using Visual Analogue Scale	Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)	D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn	Yes