The Effect of Low-frequency rTMS on Motor Function in PD Patients With Freezing of Gait
NCT ID: NCT02221544
Last Updated: 2014-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2014-09-30
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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rTMS treatment followed by Sham
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
Low-frequency repetitive Transcranial Magnetic Stimulation
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.
rTMS maintenance
Same treatment as in rTMS treatment intervention, but only once a week for a month
Sham
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.
Sham maintenance
The same as Sham stimuli intervention, but once a week for a month
Sham treatment followed by rTMS
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
Low-frequency repetitive Transcranial Magnetic Stimulation
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.
rTMS maintenance
Same treatment as in rTMS treatment intervention, but only once a week for a month
Sham
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.
Sham maintenance
The same as Sham stimuli intervention, but once a week for a month
Interventions
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Low-frequency repetitive Transcranial Magnetic Stimulation
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.
rTMS maintenance
Same treatment as in rTMS treatment intervention, but only once a week for a month
Sham
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.
Sham maintenance
The same as Sham stimuli intervention, but once a week for a month
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The mini-mental state examination questionnaire score above 24 points.
3. Suffer from a disabling phenomenon called Freezing of Gait (FoG) (Freezing Of Gait questionnaire score\> = 10)
4. Negative responses to the Preliminary Safety Magnetic Stimulation Treatment questionnaire.
Exclusion Criteria
2. Severe personality disorder.
3. High Blood Pressure.
4. History of epilepsy, seizures or convulsions.
5. History of epilepsy or convulsions in first-degree relatives.
6. History of head injury or stroke.
7. Metal remains of the skull or inside the brain (outside the oral cavity).
8. Surgeries including metallic implants or known history of metal particles in the eye, pacemakers, hearing devices transplantation, or medical pumps.
9. Current history of migraines for the last six months.
10. A history of drug or alcohol abuse
11. Other medical research in the time to experiment or three months ahead. -
50 Years
89 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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michal roll
Director of the R&D division in the Tel Aviv Sourasky Medical Center (TASMC)
Principal Investigators
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Nir Giladi, MD
Role: PRINCIPAL_INVESTIGATOR
Tel-Aviv Sourasky Medical Center
Locations
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Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TASMC-13-NG-599-CTIL
Identifier Type: -
Identifier Source: org_study_id
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