- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03219892
rTMS for the Treatment of Freezing of Gait in Parkinson's Disease
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Freezing of Gait in Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Freezing of gait (FOG) is a common and debilitating symptom in patients with Parkinson's disease (PD), characterized by sudden and brief episodes of inability to produce effective forward stepping. FOG is a major risk factor for falls, and greatly contributes to reduced mobility and quality of daily life. Treatment of FOG has been perceived as a very challenging task. Although various treatment approaches exist, including pharmacological and surgical options, evidence is inconclusive for many approaches and no clear treatment protocols are available until now.
Repetitive transcranial magnetic stimulation (rTMS), a noninvasive neural modulation technique, has been closely applied as a treatment for various neurologic and psychiatric disorders. A recent meta-analysis demonstrated that rTMS could improve motor symptoms for PD patients with a moderate effect size. To date, however, only few rTMS studies have focused on its efficacy on FOG in patients with parkinsonism, and most of them targeted the primary motor cortex or dorsolateral prefrontal cortex . Even though some evidence indicates the involvement of the SMA in FOG, no report has described the SMA rTMS in PD patients with FOG.
Moreover, few studies combined functional magnetic resonance imaging (fMRI) and rTMS to unravel the mechanism of its beneficial effects. To address these issues, the investigators conducted a randomized, double-blind, sham-controlled study to explore the efficiency of SMA-rTMS on FOG in PD patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing, China, 100053
- Xuanwu Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Idiopathic PD patients.
- Presenting with FOG.
- The mini-mental state examination questionnaire score above 24 points.
Exclusion Criteria:
- Other neurological or psychiatric disorders.
- History of epilepsy, seizures or convulsions.
- Metal implantation.
- History of exposure to rTMS in the past (to minimizing risk of unblinding sham condition).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: High-frequency rTMS
Patients randomized to this group will receive rTMS delivering over the supplementary motor area (SMA).
Each treatment consists 1000 pulses (5-second burst of 10Hz rTMS, repeated 20 times at every minute ).Stimulus intensity is 90% of resting motor threshold.
A figure-of-8 coil is connected to a biphasic magnetic stimulator, and the induced current is perpendicular to the midline.
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It is delivered at a 5-second burst of 10Hz stimuli, repeated 20 times at every minute.
Each treatment contains a total of 1000 pulses.
Stimulus intensity is 90% of resting motor threshold.
The SMA stimulation will be given using a coil centered at points 3-cm anterior to the leg motor area in the sagittal midline.
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Sham Comparator: Sham rTMS
Patients randomized to this group will receive the sham rTMS.
The procedure is same as used in patients receiving experimental rTMS, except that the coil is angled 90° away.
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The procedure will be same as the high-frequency rTMS except that the coil is 90° angled away.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of the New Freezing of Gait Questionnaire (NFOGQ) Score
Time Frame: Pre-treatment, post-treatment 4 weeks
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NFOGQ ranges from 0-24 points.
It is used to quantify changes of the FOG frequency and severity.
Higher scores mean a worse outcome.
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Pre-treatment, post-treatment 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor Subscale of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS Part III)
Time Frame: Pre-treatment, post-treatment 4 weeks
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The motor subscale of the Movement Disorder Society Unified Parkinson's Disease Rating Scale evaluates the overall motor symptoms in PD, ranging from 0-112 points.
Higher scores mean a worse outcome.
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Pre-treatment, post-treatment 4 weeks
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Cadence
Time Frame: Pre-treatment, post-treatment 4 weeks
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To assess the changes of straight walking function.
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Pre-treatment, post-treatment 4 weeks
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Turning Duration
Time Frame: Pre-treatment, post-treatment 4 weeks
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To assess the changes of turning function.
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Pre-treatment, post-treatment 4 weeks
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Changes of Brain Functional Connectivity.
Time Frame: Pre-treatment, post-treatment at 2 weeks
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functional connectivity will be assessed using fMRI, which can help understand the neural mechanism of the rTMS treatment.
Using the baseline scans, the imaging biomarkers for freezing of gait and Parkinson's disease were developed by contrasting the connectivity profiles of patients with freezing of gait to those without freezing of gait and normal controls, respectively.
These two biomarkers were then interrogated to assess the rTMS effects on connectivity patterns.
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Pre-treatment, post-treatment at 2 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Piu Chan, MD, PhD, Xuanwu Hospital, Beijing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z171100000117013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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