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Sponsors and Collaborators: |
Sheba Medical Center Weizmann Institute of Science |
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Information provided by: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00625300 |
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 safety in this population.
Condition | Intervention | Phase |
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Parkinson's Disease |
Device: repetitive transcranial stimulation (r-TMS) Device: Repetitive transcranial stimulation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety Study:The Influence of Repetitive Transcranial Stimulation (r-TMS) Treatment on Motor and Cognitive Measurements in Patients With Parkinson's Disease |
Estimated Enrollment: | 40 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Active treatment group: each patient will be given 3 treatment sessions per week for 4 weeks (a total of 12 sessions). Each session is 20 minutes long and will be consisted of 20Hz stimulation trains (active) over the motor cortex and the prefrontal cortex.
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Device: repetitive transcranial stimulation (r-TMS)
Each patient will be given 3 treatment sessions per week for 4 weeks (a total of 12 sessions). Each session is 20 minutes long and will be consisted of 20Hz stimulation trains (active) over the motor cortex and the prefrontal cortex.
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Placebo: Sham Comparator
Sham treatment group: each patient will be given 3 treatment sessions per week for 4 weeks (a total of 12 sessions). Each session is 20 minutes long and will be consisted of 20Hz stimulation trains (sham) over the motor cortex and the prefrontal cortex.
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Device: Repetitive transcranial stimulation
Sham treatment group: each patient will be given 3 treatment sessions per week for 4 weeks (a total of 12 sessions). Each session is 20 minutes long and will be consisted of sham stimulation trains over the motor cortex and the prefrontal cortex.
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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 pave the way for establishing a novel and effective treatment for this disorder.
Design:A prospective, double blind sham-controled study.
No. of centers:
One: Tel-Hashomer Medical Center, affiliated to Sackler school of Medicine, Tel -Aviv University, Israel.
Study Population:Forty patients with idiopathic PD, Hoehn and Yahr stages II to IV, on stable antiparkinsonian therapy, with partial response.
Study Duration:Two years
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Oren S Cohen, MD | +97235305296 ext - | oren.cohen@sheba.health.gov.il |
Contact: Sharon - Hassin-Baer, MD | +97235305791 ext - | shassin@post.tau.ac.il |
Israel, - | |
Sheba Medical Center, Tel Hashomer | |
Ramat Gan, -, Israel, 52621 |
Responsible Party: | Shema Medical Center ( Dr. Oren Cohen- Principal investigator ) |
Study ID Numbers: | SHEBA-08-4726-OC-CTIL |
Study First Received: | February 13, 2008 |
Last Updated: | February 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00625300 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
repetitive transcranial stimulation Parkinson's Disease |
Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Nervous System Diseases |