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This study is a double blind comparative study examining the effectiveness of the rTMS treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We hypothesize that treatment using rTMS stimulation on frontal lobe areas will improve gait quality and decrease the frequency of FOG in patients with Parkinson's disease.
A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) improves motor symptoms in patients with Parkinson's disease (PD).
The present study is a comparative study that examines the effectiveness of rTMS treatment technique Freezing of Gait (FOG) phenomenon in Parkinson's disease patients. We hypothesize that treatment using rTMS stimulation on frontal areas will decreasing frequency of FOGs in patients with Parkinson's disease and improve gait quality and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS treatment followed by Sham | Experimental | A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) followed by rTMS maintenance period (1 month) and followed by sham treatment in order to show the efficacy of treatment |
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| Sham treatment followed by rTMS | Experimental | A course of sham followed by followed by sham maintenance period (1 month) and than followed by low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) in order to show the effectiveness of rTMS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-frequency repetitive Transcranial Magnetic Stimulation | Device | Participants will receive treatment at a frequency of 3 sessions per week for 4 weeks (12 sessions). In each session patient will receive repetitive Transcranial Magnetic Stimulation using a stimulation frequency of 10 Hz for half an hour. The treatment is done by attaching an electromagnetic coil to the scalp using a special hat. Each patient has a personal hat which serves him throughout the entire process. The treatment is performed without anesthesia and patient fully conscious. During the treatment he sits comfortably on a chair, meanwhile the magnetic field passes through the skull into the brain. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in frequency and severity of the freezing of gait phenomenon | The new version of the Freezing of Gait questionnaire will be used to quantify the frequency and severity of this symptom. The score will be compared to baseline. | One week post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Community ambulation | Will be assessed using 1) the Habitual Physical Activity Questionnaire (HPAQ). It will quantify the type and amount of regular physical activity. 2) A body-worn small lightweight device that will be worn by the subject for 7 days to monitor stepping and physical activity. | One week post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nir Giladi, MD | Contact | 972-3-6974790 | nirg@tlvmc.gov.il | |
| Anat Mirelman, PhD | Contact | 972-3-6974958 | anatmi@tlvmc.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Nir Giladi, MD | Tel-Aviv Sourasky Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| rTMS maintenance | Device | Same treatment as in rTMS treatment intervention, but only once a week for a month |
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| Sham | Device | Participants will receive sham treatment at a frequency of 3 sessions per week for 4 weeks (12 sessions total) for half an hour each session. The treatment is done by attaching an electromagnetic coil to the scalp but without turning on the magnetic field. |
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| Sham maintenance | Device | The same as Sham stimuli intervention, but once a week for a month |
|
| Changes in endurance |
This measure will be assessed using the 2 minute walk test. The distance walked during 2 minutes will be compared to baseline performance. |
| One week post intervention |
| Balance | Balance and lower extremity function will be assessed using performance-based measures: (1) The Four Square Step Test (FSST), (2) The Short Physical Performance Battery (SPPB), and (3) The Mini- Balance Evaluation Systems Test (mini-BEST). | One week post intervention |
| Immediate changes in blood pressure | Measuring blood pressure will monitor subjects' autonomic response to the treatment. Measures will be compared before and after receiving the treatment | Every session, immediately after receiving the treatment |
| Immediate change in gait function | Gait speed and variability will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance. | One week post intervention |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |