Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Pain Perception in Parkinson's Disease (rTMS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01275573 |
Recruitment Status
:
Completed
First Posted
: January 12, 2011
Last Update Posted
: June 19, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease | Device: Repetitive Transcranial Magnetic Stimulation | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
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 Start Date : | October 2010 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
healthy volunteers
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
|
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.
Other Name: non applicable
|
painful Parkinson's disease patients
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
|
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.
Other Name: non applicable
|
painless Parkinson's disease patients
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
|
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.
Other Name: non applicable
|
- Change of subjective pain threshold determined using thermal stimulation (Thermotest) with the method of levels after rTMS session [ Time Frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn ]Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
- Analgesic effect of Repetitive Transcranial Magnetic Stimulation using Visual Analogue Scale [ Time Frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn ]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) [ Time Frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn ]Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
- Mood assessment using Visual Analogue Scale [ Time Frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn ]Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275573
France | |
Purpan Hospital | |
Toulouse, France, 31000 |
Principal Investigator: | Christine Brefel-Courbon, MD | Toulouse Hospital |
Responsible Party: | University Hospital, Toulouse |
ClinicalTrials.gov Identifier: | NCT01275573 History of Changes |
Other Study ID Numbers: |
09 155 02 |
First Posted: | January 12, 2011 Key Record Dates |
Last Update Posted: | June 19, 2013 |
Last Verified: | June 2013 |
Keywords provided by University Hospital, Toulouse:
Repetitive Transcranial Magnetic Stimulation pain threshold Parkinson's disease Pain threshold in Parkinson's disease |
Additional relevant MeSH terms:
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |