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

NCT ID: NCT00858546

Last Updated: 2009-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-07-31

Brief Summary

The aim of the 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 Parkinson's disease (PD) and to establish its safety in this population.

The investigators anticipate to recruit 10 patients to an open pilot study. All patients will receive an active rTMS stimulation and will be given 12 treatment sessions, over a period of up to 4 weeks. Each of the 12 daily treatment sessions (lasting about 30 minutes each), will be consisted of 25 stimulation trains over the prefrontal cortex (20Hz trains, 2 seconds each with an inter-train interval of 20 seconds) and one train of 15 minutes at 1 Hz over the the motor cortex.

The following outcome measures will be taken prior to the treatment (screening visit), and at day 1, 10, 30, 60, and 90:

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 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

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active repetitive transcranial Stimulation

Active repetitive transcranial Stimulation

Group Type: EXPERIMENTAL

Repetitive transcranial stimulation

Intervention Type: DEVICE

Repetitive transcranial stimulation

Interventions

Repetitive transcranial stimulation

Repetitive transcranial stimulation

Intervention Type: DEVICE

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 Unstable 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sheba Medical Center

Locations

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SHEBA-09-6874-OC-CTIL

Identifier Type: -

Identifier Source: org_study_id