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

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Device: repetitive transcranial stimulation (r-TMS); Device: Repetitive transcranial stimulation

• Registration Number: NCT00625300
• Lead Sponsor: Sheba Medical Center

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 Timeline

• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-27
• Study First Posted: 2008-02-28
• Study Start: 2008-04
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-19
• Last Update Posted: 2009-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	repetitive transcranial stimulation (r-TMS)	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.
Placebo	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 20Hz stimulation trains (sham) over the motor cortex and the prefrontal cortex.

Primary Outcome Measures

Name	Time	Method
Unified Parkinson Disease Rating Scale (UPDRS)(Motor Part)	10-90 days

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression of Severity (CGIS)	10-90 days

Trial Locations

Locations (1)

Sheba Medical Center, Tel Hashomer; 🇮🇱 Ramat Gan, Israel