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Clinical Trials/NCT03219892
NCT03219892
Completed
Not Applicable

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Freezing of Gait in Parkinson's Disease

Xuanwu Hospital, Beijing1 site in 1 country30 target enrollmentDecember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Xuanwu Hospital, Beijing
Enrollment
30
Locations
1
Primary Endpoint
Changes of the New Freezing of Gait Questionnaire (NFOGQ) Score
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study is a double blind comparative study examining the effectiveness of the rTMS treatment on Freezing of Gait (FOG) in patients with Parkinson's disease (PD). The investigators hypothesize that treatment with rTMS on supplemental motor area will improve gait quality and decrease the frequency of FOG in PD patients.

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2016
End Date
December 1, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Piu Chan

Director

Xuanwu Hospital, Beijing

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Changes of the New Freezing of Gait Questionnaire (NFOGQ) Score

Time Frame: Pre-treatment, post-treatment 4 weeks

NFOGQ ranges from 0-24 points. It is used to quantify changes of the FOG frequency and severity. Higher scores mean a worse outcome.

Secondary Outcomes

  • Cadence(Pre-treatment, post-treatment 4 weeks)
  • Turning Duration(Pre-treatment, post-treatment 4 weeks)
  • Changes of Brain Functional Connectivity.(Pre-treatment, post-treatment at 2 weeks)
  • Motor Subscale of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS Part III)(Pre-treatment, post-treatment 4 weeks)

Study Sites (1)

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