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

Primary Purpose

Parkinson Disease, Gait Disorders, Neurologic

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rTMS
sham stimulation
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring freezing of gait, FMRI, rTMS

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects fulfilled the diagnosis of idiopathic Parkinson's disease according to MDS-PD criteria
  • Hoehn & Yahr (H-Y) stage was 2 or 3
  • All subjects had freezing of gait which was identified by FOGQ

Exclusion Criteria:

  • cognitive impairment (MMSE score<22) or major depression (HAMD-24 score>25)
  • severe visual and/or haring impairment
  • significant medical or psychiatric illnesses
  • history of deep brain stimulation (DBS) surgery or pacemaker implantation. MRI cannot be performed in those patients
  • current treatment with medication cannot be maintained during the study

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

rTMS over M1 region

rTMS over supplementary motor area (SMA)

sham stimulation

Arm Description

The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is M1 region.

The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is SMA region.

Outcomes

Primary Outcome Measures

the change of freezing of gait questionnaire (FOGQ)
a self-assessment scale for evaluating FOG severity,the minimum value is 0, the maximum value is 24, and higher scores mean a worse outcome.

Secondary Outcome Measures

the change of freezing of gait score (FOG score)
assess the severity of FOG, the minimum value is 0, the maximum value is 36, and higher scores mean a worse outcome.
the change of score of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
assess the motor ability, the minimum value is 0, the maximum value is 132, and higher scores mean a worse outcome.
the change of Hamilton Depression (HAMD) Scale
assess the severity of depression, the minimum value is 0, the maximum value is 76, and higher scores mean a worse outcome.
the change of Mini-mental State Examination (MMSE) scale
assess the severity of mental state, the minimum value is 0, the maximum value is 30, and higher scores mean a worse outcome.
the change of Parkinson's Disease Questionnaire (PDQ-39)
assess the quality of life, the minimum value is 0, the maximum value is 156, and higher scores mean a worse outcome.
functional image of the brain (FMRI)
graph theoretical analysis of the brain network

Full Information

First Posted
April 27, 2020
Last Updated
June 11, 2020
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04431570
Brief Title
Repetitive Transcranial Magnetic Stimulation for the Treatment of Freezing of Gait in Parkinson's Disease
Official Title
Repetitive Transcranial Magnetic Stimulation for the Treatment of Freezing of Gait in Parkinson's Disease: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Anticipated)
Primary Completion Date
April 14, 2022 (Anticipated)
Study Completion Date
June 14, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Freezing of gait (FOG) is a common and devastating symptom in advanced stage Parkinson's disease (PD), which contributes to falls and disability. Unfortunately, there is no effective pharmacological treatment for FOG. It is suggested that the cortex-basal ganglia circuit, especially the frontal lobe, plays an important role in the pathogenesis of FOG. Repetitive transcranial magnetic stimulation (rTMS) effects over the cortex and affects the subcortical neural circuits. Previous studies have demonstrated that rTMS can improve FOG for PD patients. In the present randomized controlled trial (RCT) study, the invastigators aim to investigate the efficiency of rTMS over different motor regions of frontal lobe. The efficacy of treatment is evaluated by the score of FOG questionnaire and FOG provoking test, and the changing of neural network shown by functional magnetic resonance imaging (FMRI). Then the effects of rTMS over different brain regions will be compared for choosing a better target. The study will provide the evidence for non-invasive neuro-modulation of Parkinson's disease with freezing of gait (PD-FOG).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Gait Disorders, Neurologic
Keywords
freezing of gait, FMRI, rTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rTMS over M1 region
Arm Type
Experimental
Arm Description
The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is M1 region.
Arm Title
rTMS over supplementary motor area (SMA)
Arm Type
Experimental
Arm Description
The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is SMA region.
Arm Title
sham stimulation
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
The device is made in London, United Kingdom
Intervention Type
Device
Intervention Name(s)
sham stimulation
Intervention Description
the device of sham stimulation was MagStim MC-P-B70 placebo butterfly coil
Primary Outcome Measure Information:
Title
the change of freezing of gait questionnaire (FOGQ)
Description
a self-assessment scale for evaluating FOG severity,the minimum value is 0, the maximum value is 24, and higher scores mean a worse outcome.
Time Frame
through study completion, an average of 2 weeks
Secondary Outcome Measure Information:
Title
the change of freezing of gait score (FOG score)
Description
assess the severity of FOG, the minimum value is 0, the maximum value is 36, and higher scores mean a worse outcome.
Time Frame
through study completion, an average of 2 weeks
Title
the change of score of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
Description
assess the motor ability, the minimum value is 0, the maximum value is 132, and higher scores mean a worse outcome.
Time Frame
through study completion, an average of 2 weeks
Title
the change of Hamilton Depression (HAMD) Scale
Description
assess the severity of depression, the minimum value is 0, the maximum value is 76, and higher scores mean a worse outcome.
Time Frame
through study completion, an average of 2 weeks
Title
the change of Mini-mental State Examination (MMSE) scale
Description
assess the severity of mental state, the minimum value is 0, the maximum value is 30, and higher scores mean a worse outcome.
Time Frame
through study completion, an average of 2 weeks
Title
the change of Parkinson's Disease Questionnaire (PDQ-39)
Description
assess the quality of life, the minimum value is 0, the maximum value is 156, and higher scores mean a worse outcome.
Time Frame
through study completion, an average of 2 weeks
Title
functional image of the brain (FMRI)
Description
graph theoretical analysis of the brain network
Time Frame
through study completion, an average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects fulfilled the diagnosis of idiopathic Parkinson's disease according to MDS-PD criteria Hoehn & Yahr (H-Y) stage was 2 or 3 All subjects had freezing of gait which was identified by FOGQ Exclusion Criteria: cognitive impairment (MMSE score<22) or major depression (HAMD-24 score>25) severe visual and/or haring impairment significant medical or psychiatric illnesses history of deep brain stimulation (DBS) surgery or pacemaker implantation. MRI cannot be performed in those patients current treatment with medication cannot be maintained during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Han Wang, doctor
Phone
+8618600044179
Email
18600044179@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Xu, doctor
Phone
+8618614069673
Email
pumc04xd@163.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taisheng Li, MD. PhD.
Phone
86 10 65295086
Email
Litsh@263.net
First Name & Middle Initial & Last Name & Degree
Taisheng Li, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ling Luo, MD

12. IPD Sharing Statement

Learn more about this trial

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

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