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| Name | Class |
|---|---|
| Brainsway | INDUSTRY |
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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.
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:
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. Beck Depression Inventory (BDI) Cognition
Side effects will be closely monitored by the researchers and will be promptly reported to the IRB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active repetitive Transcranial Stimulation | Active Comparator | 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. |
|
| Sham Stimulation | Sham Comparator | The control arm group will receive sham stimulations in identical treatment and maintenance schedules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive transcranial stimulation (r-TMS) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Unified Parkinson's Disease Rating Scale (UPDRS) score | A decrease in the total UPDRS score in general and in the Motor UPDRS (part 3) score. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| CGIS | Rater and patient's opinion on the change in thier PD due to the TMS treatment | 3 months |
| Decrease in time in Pegboard test | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oren Cohen, MD | Contact | +972-3-5305296 | Oren.Cohen@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Oren Cohen, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Tel Litwinsky | 52621 | Israel |
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| repetitive transcranial stimulation (r-TMS) | Device | Sham treatment with the H-coil will include sham stimulation over the motor cortex and over the prefrontal cortex. |
|
| Increase in Tapping test | 3 months |
| Decrease in Time Up&Go test | Patient has to get up from a chair, walk 3 meters, turn around and return to sit on the chair. | 3 months |
| Increase in Word fluency | Number of words the patient can think of that start with a certian letter or belong to a certian catagory, in one minute. | 3 months |
| Increase in Digits Forward & Backwards test | 3 months |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 3 months |