A Phase 2 interventional study of Repetitive Transcranial Magnetic Stimulation in Parkinson's Disease, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-19.
Sponsored by University Hospital, Toulouse · Phase 2, Interventional, and Basic science
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
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For patients:
For Healthy volunteers
Exclusion Criteria:
For patients:
For Healthy volunteers:
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
Device: Repetitive Transcranial Magnetic Stimulation
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
Device: Repetitive Transcranial Magnetic Stimulation
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.
Also known as: non applicable
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)
Time frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Analgesic effect of Repetitive Transcranial Magnetic Stimulation using Visual Analogue Scale
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
Time frame: 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)
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
Time frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Mood assessment using Visual Analogue Scale
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
Time frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse