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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease focused on measuring Repetitive Transcranial Magnetic Stimulation, pain threshold, Parkinson's disease, Pain threshold in Parkinson's disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Purpan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

healthy volunteers

painful Parkinson's disease patients

painless Parkinson's disease patients

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Analgesic effect of Repetitive Transcranial Magnetic Stimulation using Visual Analogue Scale
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)
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
Mood assessment using Visual Analogue Scale
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)

Full Information

First Posted
December 10, 2010
Last Updated
June 18, 2013
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT01275573
Brief Title
Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Pain Perception in Parkinson's Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Repetitive Transcranial Magnetic Stimulation, pain threshold, Parkinson's disease, Pain threshold in Parkinson's disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy volunteers
Arm Type
Other
Arm Description
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
Arm Title
painful Parkinson's disease patients
Arm Type
Other
Arm Description
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
Arm Title
painless Parkinson's disease patients
Arm Type
Other
Arm Description
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Other Intervention Name(s)
non applicable
Intervention 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.
Primary Outcome Measure Information:
Title
Change of subjective pain threshold determined using thermal stimulation (Thermotest) with the method of levels after rTMS session
Description
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
Time Frame
D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Secondary Outcome Measure Information:
Title
Analgesic effect of Repetitive Transcranial Magnetic Stimulation using Visual Analogue Scale
Description
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
Time Frame
D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Title
- Clinical evaluation of the severity of the motor handicap of patients using Unified's Parkinson's Disease Rating Scale (UPDRSIII)
Description
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
Time Frame
D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Title
Mood assessment using Visual Analogue Scale
Description
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
Time Frame
D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Brefel-Courbon, MD
Organizational Affiliation
Toulouse Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purpan Hospital
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

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

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