Status:
COMPLETED
Repetitive Transcranial Stimulation (r-TMS) Treatment for Patients With Parkinson's Disease
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
Weizmann Institute of Science
Conditions:
Parkinson's Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the effects of deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with Parkinson's disease (PD) and to establish its safet...
Detailed Description
Study rational:We anticipate that reaching deeper brain layers and larger volume of activation with the novel H-coil may induce significantly better therapeutic effects in patients with PD and will pa...
Eligibility Criteria
Inclusion
- PD patients aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn \& Yahr stages II - IV while "off". Participants on antidepressants should be at least 2 months on stable therapy.
Exclusion
- Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
- Patients on neuroleptics.
- Patients with dementia or any unstable medical disorder.
- History or current hypertension.
- History of head injury or neurosurgical interventions.
- History of any metal in the head (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
- History of migraine or frequent or severe headaches.
- History of hearing loss.
- The presence of cochlear implants
- History of drug abuse or alcoholism.
- Pregnancy or not using a reliable method of birth control.
- Participation in current clinical study or clinical study within 30 days prior to this study.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00625300
Start Date
April 1 2008
End Date
July 1 2009
Last Update
October 20 2009
Active Locations (1)
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1
Sheba Medical Center, Tel Hashomer
Ramat Gan, Israel, 52621