The Effect of Low-frequency rTMS on Motor Function in PD Patients With Freezing of Gait
The Effect of Low-frequency Repetitive Transcranial Magnetic Stimulation on Motor Function in Patients With Parkinson's Disease (PD) With Freezing of Gait (FOG).
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2014
CompletedFirst Posted
Study publicly available on registry
August 20, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 20, 2014
August 1, 2014
1.2 years
August 19, 2014
August 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Community ambulation
One week post intervention
Changes in endurance
One week post intervention
Balance
One week post intervention
Immediate changes in blood pressure
Every session, immediately after receiving the treatment
Immediate change in gait function
One week post intervention
Study Arms (2)
rTMS treatment followed by Sham
EXPERIMENTALA 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
EXPERIMENTALA 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
Interventions
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.
Same treatment as in rTMS treatment intervention, but only once a week for a month
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.
The same as Sham stimuli intervention, but once a week for a month
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nir Giladi, MD
Tel-Aviv Sourasky Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the R&D division in the Tel Aviv Sourasky Medical Center (TASMC)
Study Record Dates
First Submitted
August 19, 2014
First Posted
August 20, 2014
Study Start
September 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
August 20, 2014
Record last verified: 2014-08