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The Effect of Low-frequency rTMS on Motor Function in PD Patients With Freezing of Gait

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ClinicalTrials.gov Identifier: NCT02221544
Recruitment Status : Unknown
Verified August 2014 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
michal roll, 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Low-frequency repetitive Transcranial Magnetic Stimulation Device: rTMS maintenance Device: Sham Device: Sham maintenance Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Device: 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.

Other Name: rTMS treatment

Device: rTMS maintenance
Same treatment as in rTMS treatment intervention, but only once a week for a month

Device: 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.

Device: Sham maintenance
The same as Sham stimuli intervention, but once a week for a month

Experimental: 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
Device: 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.

Other Name: rTMS treatment

Device: rTMS maintenance
Same treatment as in rTMS treatment intervention, but only once a week for a month

Device: 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.

Device: Sham maintenance
The same as Sham stimuli intervention, but once a week for a month




Primary Outcome Measures :
  1. Changes in frequency and severity of the freezing of gait phenomenon [ Time Frame: 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 :
  1. Community ambulation [ Time Frame: 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.

  2. Changes in endurance [ Time Frame: 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.

  3. Balance [ Time Frame: 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).

  4. Immediate changes in blood pressure [ Time Frame: 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

  5. Immediate change in gait function [ Time Frame: 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.



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Ages Eligible for Study:   50 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
  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:

  1. Other neurological or psychiatric disorders.
  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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221544


Contacts
Contact: Nir Giladi, MD 972-3-6974790 nirg@tlvmc.gov.il
Contact: Anat Mirelman, PhD 972-3-6974958 anatmi@tlvmc.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Nir Giladi, MD    972-3-6974790    nirg@tlvmc.gov.il   
Contact: Anat Mirelman, PhD    972-3-6974958    anatmi@tlvmc.gov.il   
Sub-Investigator: Anat Mirelman, PhD         
Sub-Investigator: Jeff Hausdorff, PhD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Nir Giladi, MD Tel-Aviv Sourasky Medical Center

Responsible Party: michal roll, Director of the R&D division in the Tel Aviv Sourasky Medical Center (TASMC), Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02221544     History of Changes
Other Study ID Numbers: TASMC-13-NG-599-CTIL
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
Parkinson's disease, rTMS, Freezing of Gait

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases