The Effect of Low-frequency rTMS on Motor Function in PD Patients With Freezing of Gait
- Conditions
- Parkinson's Disease
- Interventions
- Device: Low-frequency repetitive Transcranial Magnetic StimulationDevice: rTMS maintenanceDevice: ShamDevice: Sham maintenance
- Registration Number
- NCT02221544
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
- The mini-mental state examination questionnaire score above 24 points.
- Suffer from a disabling phenomenon called Freezing of Gait (FoG) (Freezing Of Gait questionnaire score> = 10)
- Negative responses to the Preliminary Safety Magnetic Stimulation Treatment questionnaire.
- Other neurological or psychiatric disorders.
- Severe personality disorder.
- High Blood Pressure.
- History of epilepsy, seizures or convulsions.
- History of epilepsy or convulsions in first-degree relatives.
- History of head injury or stroke.
- Metal remains of the skull or inside the brain (outside the oral cavity).
- Surgeries including metallic implants or known history of metal particles in the eye, pacemakers, hearing devices transplantation, or medical pumps.
- Current history of migraines for the last six months.
- A history of drug or alcohol abuse
- Other medical research in the time to experiment or three months ahead. -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description rTMS treatment followed by Sham Low-frequency repetitive Transcranial Magnetic Stimulation 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 rTMS treatment followed by Sham 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 Sham treatment followed by rTMS Sham 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 rTMS treatment followed by Sham Sham maintenance 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 rTMS treatment followed by Sham rTMS maintenance 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 Sham treatment followed by rTMS Low-frequency repetitive Transcranial Magnetic Stimulation 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 Sham treatment followed by rTMS rTMS maintenance 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 Sham treatment followed by rTMS Sham maintenance 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
- Primary Outcome Measures
Name Time Method Changes in frequency and severity of the freezing of gait phenomenon One week post intervention 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.
- Secondary Outcome Measures
Name Time Method Immediate changes in blood pressure Every session, immediately after receiving the treatment Measuring blood pressure will monitor subjects' autonomic response to the treatment. Measures will be compared before and after receiving the treatment
Community ambulation One week post intervention 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.
Changes in endurance One week post intervention This measure will be assessed using the 2 minute walk test. The distance walked during 2 minutes will be compared to baseline performance.
Balance One week post intervention 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).
Immediate change in gait function One week post intervention 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.
Trial Locations
- Locations (1)
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel