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Completed

NCT Number: NCT00625300

Repetitive Transcranial Stimulation (r-TMS) Treatment for 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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sheba Medical Center, Tel Hashomer

Ramat Gan, 52621, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 stimulation

Device

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.

Primary outcomes

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

    Time frame: 10-90 days

Secondary outcomes

  1. Clinical Global Impression of Severity (CGIS)

    Time frame: 10-90 days

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • Weizmann Institute of Science

Registry information

Official study 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

Acronym: r-TMS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 28, 2008
Registry last updated
Oct 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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