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

Sheba Medical Center20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson's Disease

Interventions

repetitive transcranial stimulation (r-TMS)DEVICE

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.

Repetitive transcranial stimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sheba Medical Center, Tel Hashomer

Ramat Gan, Israel

Outcomes

Primary Outcomes

Unified Parkinson Disease Rating Scale (UPDRS)(Motor Part)

Time frame: 10-90 days

Secondary Outcomes

Clinical Global Impression of Severity (CGIS)

Time frame: 10-90 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.