A Double Blind Sham-controled Study to Evaluate the Influence of Low Frequency Repetitive Transcranial Stimulation (r-TMS) on Motor and Cognitive Measurements in Patients With Asymmetric Parkinson's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Sheba Medical Center
Sponsor:
Collaborator:
Brainsway
Information provided by (Responsible Party):
Dr. Oren Cohen, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01367782
First received: May 30, 2011
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to test the effects of low frequency deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with asymmetric Parkinson's disease (PD), to establish its safety in this population and to test effects of maintenance treatments.


Condition Intervention
Asymmetric Parkinson's Disease
Device: repetitive transcranial stimulation (r-TMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind Sham-controled Study to Evaluate the Influence of Low Frequency Repetitive Transcranial Stimulation (r-TMS) on Motor and Cognitive Measurements in Patients With Asymmetric Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Decrease in Unified Parkinson's Disease Rating Scale (UPDRS) score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    A decrease in the total UPDRS score in general and in the Motor UPDRS (part 3) score.


Secondary Outcome Measures:
  • CGIS [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Rater and patient's opinion on the change in thier PD due to the TMS treatment

  • Decrease in time in Pegboard test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Increase in Tapping test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Decrease in Time Up&Go test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Patient has to get up from a chair, walk 3 meters, turn around and return to sit on the chair.

  • Increase in Word fluency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of words the patient can think of that start with a certian letter or belong to a certian catagory, in one minute.

  • Increase in Digits Forward & Backwards test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 44
Study Start Date: May 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active repetitive Transcranial Stimulation
Each patient will be given 12 stimulation sessions, over a period of 4 weeks, and then a maintenance phase consisting of 8 stimulation sessions for the first 4 weeks and additional 4 stimulation sessions during the following 4 weeks.
Device: repetitive transcranial stimulation (r-TMS)
Active treatment with the H-coil will include stimulation over the motor cortex (1 Hz stimulation 110% of the motor threshold for 15 minutes) and over the prefrontal cortex (10Hz stimulation 100% of the motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes).
Sham Comparator: Sham Stimulation
The control arm group will receive sham stimulations in identical treatment and maintenance schedules.
Device: repetitive transcranial stimulation (r-TMS)
Sham treatment with the H-coil will include sham stimulation over the motor cortex and over the prefrontal cortex.

Detailed Description:

PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn & Yahr stages II - IV while "off" will be recruited. Participants on antidepressants should be at least 2 months on stable therapy.

Patient will be excluded if:

  1. Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
  2. Patients on neuroleptics.
  3. Patients with unstable medical disorder.
  4. History or current unstable hypertension.
  5. History of head injury or neurosurgical interventions.
  6. History of any metal in the head (outside the mouth).
  7. Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
  8. History of migraine or frequent or severe headaches.
  9. Current hearing loss.
  10. The presence of cochlear implants
  11. Current drug abuse or alcoholism.
  12. Pregnancy or not using a reliable method of birth control.
  13. Participation in current clinical study or clinical study within 30 days prior to this study.

Patients will be to randomized to an active rTMS arm or to a sham stimulation arm. Each patient will be given 12 stimulation sessions, over a period of 4 weeks, and then a maintenance phase consisting of 8 stimulation sessions for the first 4 weeks and additional 4 stimulation sessions during the following 4 weeks.

Active treatment with the H-coil will include stimulation over the motor cortex (1 Hz stimulation 110% of the motor threshold for 15 minutes) and over the prefrontal cortex (10Hz stimulation 100% of the motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes). The control arm group will receive sham stimulations in identical treatment and maintenance schedules. Patients from the sham group who will complete the study will be given the opportunity to receive 12 sessions of real r-TMS treatment over 4 weeks as the treatment group.

The following outcome measures will be taken prior to the treatment (screening visit), and at day 1, 10, 30, 60 and 90. Evaluation will be while subjects are both at "on" and "off".

Motor:

  1. Unified Parkinson's Disease Rating Scale (UPDRS )
  2. Clinical Global Impression of Severity (CGIS)
  3. Pegboard test.
  4. Tapping test
  5. Up & Go test
  6. Abnormal Involuntary Movement Scale (AIMS) Mood and affect

1. Beck Depression Inventory (BDI) Cognition

  1. Mini mental State examination (MMSE)
  2. Digit forward and backward tests.
  3. Word fluency.
  4. Frontal Assessment Battery (FAB)

Side effects will be closely monitored by the researchers and will be promptly reported to the IRB.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PD patients with asymmetric disease 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:

  1. Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
  2. Patients on neuroleptics.
  3. Patients with unstable medical disorder.
  4. History or current unstable hypertension.
  5. History of head injury or neurosurgical interventions.
  6. History of any metal in the head (outside the mouth).
  7. Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
  8. History of migraine or frequent or severe headaches.
  9. Current hearing loss.
  10. The presence of cochlear implants
  11. Current drug abuse or alcoholism.
  12. Pregnancy or not using a reliable method of birth control.
  13. Participation in current clinical study or clinical study within 30 days prior to this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367782

Contacts
Contact: Oren Cohen, MD +972-3-5305296 Oren.Cohen@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Contact: Oren Cohen, MD       Oren.Cohen@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Brainsway
Investigators
Principal Investigator: Oren Cohen, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Oren Cohen, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01367782     History of Changes
Other Study ID Numbers: SHEBA-11-8470-OC-CTIL
Study First Received: May 30, 2011
Last Updated: December 3, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
UPDRS

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 19, 2014