NCT01275573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

1.7 years

First QC Date

December 10, 2010

Last Update Submit

June 18, 2013

Conditions

Parkinson's Disease

Keywords

Repetitive Transcranial Magnetic Stimulationpain thresholdParkinson's diseasePain threshold in Parkinson's disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

Study Arms (3)

healthy volunteers

OTHER

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

Device: Repetitive Transcranial Magnetic Stimulation

painful Parkinson's disease patients

OTHER

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

Device: Repetitive Transcranial Magnetic Stimulation

painless Parkinson's disease patients

OTHER

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

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

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.

Also known as: non applicable
healthy volunteerspainful Parkinson's disease patientspainless Parkinson's disease patients

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purpan Hospital

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Christine Brefel-Courbon, MD

    Toulouse Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2010

First Posted

January 12, 2011

Study Start

October 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

FR(1)