- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00625300
Repetitive Transcranial Stimulation (r-TMS) Treatment for Patients With Parkinson's Disease (r-TMS)
Efficacy and Safety Study:The Influence of Repetitive Transcranial Stimulation (r-TMS) Treatment on Motor and Cognitive Measurements in Patients With Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Ramat Gan, Israel, 52621
- Sheba Medical Center, Tel Hashomer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
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.
|
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 Comparator: Placebo
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Unified Parkinson Disease Rating Scale (UPDRS)(Motor Part)
Time Frame: 10-90 days
|
10-90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical Global Impression of Severity (CGIS)
Time Frame: 10-90 days
|
10-90 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-08-4726-OC-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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