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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
repetitive transcranial stimulation (r-TMS)
Repetitive transcranial stimulation
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring repetitive transcranial stimulation, Parkinson's Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheba Medical Center, Tel Hashomer

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

1

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical Global Impression of Severity (CGIS)

Full Information

First Posted
February 13, 2008
Last Updated
October 19, 2009
Sponsor
Sheba Medical Center
Collaborators
Weizmann Institute of Science
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1. Study Identification

Unique Protocol Identification Number
NCT00625300
Brief Title
Repetitive Transcranial Stimulation (r-TMS) Treatment for Patients With Parkinson's Disease
Acronym
r-TMS
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center
Collaborators
Weizmann Institute of Science

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
repetitive transcranial stimulation, Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
repetitive transcranial stimulation (r-TMS)
Intervention Description
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 Type
Device
Intervention Name(s)
Repetitive transcranial stimulation
Intervention Description
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 Outcome Measure Information:
Title
Unified Parkinson Disease Rating Scale (UPDRS)(Motor Part)
Time Frame
10-90 days
Secondary Outcome Measure Information:
Title
Clinical Global Impression of Severity (CGIS)
Time Frame
10-90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Sheba Medical Center, Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

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

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