Status:
UNKNOWN
Development of a Monitoring Set-up and Algorithm Using Functional MRI (fMRI) and EEG for Prediction of Response to Repetitive Deep Transcranial Magnetic Stimulation (rDTMS) for Patients With Parkinson's Disease
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
Brainsway
ElMindA Ltd
Conditions:
Parkinson
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
* To characterize physiological biomarkers of positive response to rDTMS using EEG and functional MRI (fMRI) in patients with PD. * To develop a set-up and algorithm for neurophysiological monitoring ...
Detailed Description
PD Patients aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria will be treated by an established rDTMS protocol will be monitored before, during and after rDTMS...
Eligibility Criteria
Inclusion
- Idiopathic PD patients aged 40-75 years;
- Hoehn and Yahr stages II to IV
- Patients on stable antiparkinsonian therapy for 1 month
- Right hand dominance with right afflicted side.
Exclusion
- Participation in current clinical study or clinical study within 30 days prior to this study.
- Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or other degenerative disease)
- Patients with significant psychiatric symptoms or history.
- Patients with psychotic symptoms or active depressive symptoms
- Treatment with neuroleptics.
- Beck depression inventory (BDI) score \<14
- Mini Mental status examination (MMSE) score \<25
- History of migraine or frequent or severe headaches.
- Significant sensory deficits, e.g., deafness or blindness History of head injury or neurosurgical interventions.
- Subjects who have concomitant epilepsy, a history of seizure/s, heat convulsions or history of epilepsy in first degree relative.
- History of any metal in the head (outside the mouth).
- The presence of cochlear implants
- Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- Subjects with an unstable medical disorder.
- Current drug abuse (including Cannabis) or alcoholism.
- Pregnancy or not using a reliable method of birth control.
- Patients with severe tremor or dyskinesia
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02249715
Start Date
November 1 2014
Last Update
September 26 2014
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