A Phase 2 interventional study of repetitive transcranial stimulation (r-TMS) and Repetitive transcranial stimulation in Parkinson's Disease, sponsored by Sheba Medical Center. Completed at 1 site in Israel. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2009-10-20.
Sponsored by Sheba Medical Center · Phase 2, Interventional, and Treatment
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.
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:1 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
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
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Exclusion Criteria:
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.
Device: repetitive transcranial stimulation (r-TMS)
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.
Device: Repetitive transcranial stimulation
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.
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.
Unified Parkinson Disease Rating Scale (UPDRS)(Motor Part)
Time frame: 10-90 days
Clinical Global Impression of Severity (CGIS)
Time frame: 10-90 days
This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center