Back to resultsThe Effect of Low-frequency rTMS on Motor Function in PD Patients With Freezing of Gait
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Low-frequency repetitive Transcranial Magnetic Stimulation
rTMS maintenance
Sham
Sham maintenance
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, rTMS, Freezing of Gait
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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. -
Sites / Locations
- Tel Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
rTMS treatment followed by Sham
Sham treatment followed by rTMS
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
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
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.
Full Information
NCT ID
NCT02221544
First Posted
August 19, 2014
Last Updated
August 19, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02221544
Brief Title
The Effect of Low-frequency rTMS on Motor Function in PD Patients With Freezing of Gait
Official Title
The Effect of Low-frequency Repetitive Transcranial Magnetic Stimulation on Motor Function in Patients With Parkinson's Disease (PD) With Freezing of Gait (FOG).
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, rTMS, Freezing of Gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rTMS treatment followed by Sham
Arm Type
Experimental
Arm Description
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
Arm Title
Sham treatment followed by rTMS
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Low-frequency repetitive Transcranial Magnetic Stimulation
Other Intervention Name(s)
rTMS treatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
rTMS maintenance
Intervention Description
Same treatment as in rTMS treatment intervention, but only once a week for a month
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham maintenance
Intervention Description
The same as Sham stimuli intervention, but once a week for a month
Primary Outcome Measure Information:
Title
Changes in frequency and severity of the freezing of gait phenomenon
Description
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.
Time Frame
One week post intervention
Secondary Outcome Measure Information:
Title
Community ambulation
Description
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.
Time Frame
One week post intervention
Title
Changes in endurance
Description
This measure will be assessed using the 2 minute walk test. The distance walked during 2 minutes will be compared to baseline performance.
Time Frame
One week post intervention
Title
Balance
Description
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).
Time Frame
One week post intervention
Title
Immediate changes in blood pressure
Description
Measuring blood pressure will monitor subjects' autonomic response to the treatment. Measures will be compared before and after receiving the treatment
Time Frame
Every session, immediately after receiving the treatment
Title
Immediate change in gait function
Description
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.
Time Frame
One week post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nir Giladi, MD
Phone
972-3-6974790
Email
nirg@tlvmc.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Anat Mirelman, PhD
Phone
972-3-6974958
Email
anatmi@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nir Giladi, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nir Giladi, MD
Phone
972-3-6974790
Email
nirg@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Anat Mirelman, PhD
Phone
972-3-6974958
Email
anatmi@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Anat Mirelman, PhD
First Name & Middle Initial & Last Name & Degree
Jeff Hausdorff, PhD
12. IPD Sharing Statement
Learn more about this trial
The Effect of Low-frequency rTMS on Motor Function in PD Patients With Freezing of Gait
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