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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

February 13, 2008
October 19, 2009
April 2008
July 2009   (final data collection date for primary outcome measure)
Unified Parkinson Disease Rating Scale (UPDRS)(Motor Part) [ Time Frame: 10-90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00625300 on ClinicalTrials.gov Archive Site
Clinical Global Impression of Severity (CGIS) [ Time Frame: 10-90 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Repetitive Transcranial Stimulation (r-TMS) Treatment for Patients With Parkinson's Disease
Efficacy and Safety Study:The Influence of Repetitive Transcranial Stimulation (r-TMS) Treatment on Motor and Cognitive Measurements in Patients With Parkinson's Disease

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00625300
SHEBA-08-4726-OC-CTIL
No
Dr. Oren Cohen- Principal investigator, Shema Medical Center
Sheba Medical Center
Weizmann Institute of Science
Not Provided
Sheba Medical Center
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP