The Influence of Low Frequency Repetitive Transcranial Stimulation (r-TMS) on Motor and Cognitive Measurements in Patients With Asymmetric Parkinson's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01016743
First received: November 18, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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) and to establish its safety in this population. The investigators 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.


Condition Intervention
UPDRS
Device: repetitive transcranial stimulation (r-TMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale (UPDRS ) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CGIS,Pegboard test.Tapping test,Up&Go test,AIMS,BDI,MMSE,Word fluencyFAB [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • UPDRS [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2009
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active repetitive transcranial Stimulation
Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes).
Device: repetitive transcranial stimulation (r-TMS)
Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes).

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. They have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
  2. Are on neuroleptics.
  3. Have dementia or any unstable medical disorder.
  4. Have a history or current unstable hypertension.
  5. Have a history of head injury or neurosurgical interventions.
  6. Have a history of any metal in the head (outside the mouth).
  7. Have a known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.

Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes).

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

8.Have a history of migraine or frequent or severe headaches. 9.Have a history of hearing loss. 10.Has a of cochlear implants 11.Have a history of drug abuse or alcoholism. 12.Is pregnant or not using a reliable method of birth control. 13.Is participating in current clinical study or clinical study within 30 days prior to this study.

  Eligibility

Ages Eligible for Study:   40 Years to 80 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:

  • 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 unstable hypertension.
  • History of head injury or neurosurgical interventions.
  • History of any metal in the head (outside the mouth).
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Sheba Medical Center: Dr. Oren Cohen PI, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01016743     History of Changes
Other Study ID Numbers: SHEBA-09-7279-OC-CTIL
Study First Received: November 18, 2009
Last Updated: November 18, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
parkinson
rTMS

ClinicalTrials.gov processed this record on September 30, 2014