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| Sponsors and Collaborators: |
Sheba Medical Center Weizman Institute of Science Revovot Israel |
| Information provided by: | Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT00625300 |
Purpose
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 |
| Genetics Home Reference related topics: | Parkinson disease |
| MedlinePlus related topics: | Parkinson's Disease |
| 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
Eligibility
| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | Not yet recruiting | ||||
| Ramat Gan, -, Israel, 52621 | |||||
| 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 | |||||
| Sheba Medical Center |
| Weizman Institute of Science Revovot Israel |
More Information
| Responsible Party: | Shema Medical Center ( Dr. Oren Cohen- Principal investigator ) |
| Study ID Numbers: | SHEBA-08-4726-OC-CTIL |
| First Received: | February 13, 2008 |
| Last Updated: | February 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00625300 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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