Repetitive Transcranial Stimulation (r-TMS) Treatment for Patients With Parkinson's Disease

This study has been completed.

Sponsor:

Collaborator:

Weizmann Institute of Science

Information provided by:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT00625300

First received: February 13, 2008

Last updated: October 19, 2009

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	February 13, 2008
Last Updated Date	October 19, 2009
Start Date ^ICMJE	April 2008
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 27, 2008)	Unified Parkinson Disease Rating Scale (UPDRS)(Motor Part) [ Time Frame: 10-90 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00625300 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 27, 2008)	Clinical Global Impression of Severity (CGIS) [ Time Frame: 10-90 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Repetitive Transcranial Stimulation (r-TMS) Treatment for Patients With Parkinson's Disease
Official Title ^ICMJE	Efficacy and Safety Study:The Influence of Repetitive Transcranial Stimulation (r-TMS) Treatment on Motor and Cognitive Measurements in Patients With Parkinson's Disease
Brief Summary	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.
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 ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Parkinson's Disease
Intervention ^ICMJE	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. 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.
Study Arm (s)	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. Intervention: Device: repetitive transcranial stimulation (r-TMS) 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. Intervention: Device: Repetitive transcranial stimulation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	July 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00625300
Other Study ID Numbers ^ICMJE	SHEBA-08-4726-OC-CTIL
Has Data Monitoring Committee	No
Responsible Party	Dr. Oren Cohen- Principal investigator, Shema Medical Center
Study Sponsor ^ICMJE	Sheba Medical Center
Collaborators ^ICMJE	Weizmann Institute of Science
Investigators ^ICMJE	Not Provided
Information Provided By	Sheba Medical Center
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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