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

This study is not yet open for participant recruitment.
Verified by Sheba Medical Center, February 2008

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
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   

U.S. FDA Resources

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

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Unified Parkinson Disease Rating Scale (UPDRS)(Motor Part) [ Time Frame: 10-90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression of Severity (CGIS) [ Time Frame: 10-90 days ] [ Designated as safety issue: No ]

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
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.
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.
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.
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.

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:

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

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625300

Contacts
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    

Locations
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    

Sponsors and Collaborators
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

Keywords provided by Sheba Medical Center:
repetitive transcranial stimulation  
Parkinson's Disease  

Study placed in the following topic categories:
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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