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

NCT ID: NCT04431570

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2022-06-14

Brief Summary

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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).

Detailed Description

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Conditions

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Parkinson Disease Gait Disorders, Neurologic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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rTMS over 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 M1 region.

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

The device is made in London, United Kingdom

rTMS over supplementary motor area (SMA)

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.

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

The device is made in London, United Kingdom

sham stimulation

Group Type SHAM_COMPARATOR

sham stimulation

Intervention Type DEVICE

the device of sham stimulation was MagStim MC-P-B70 placebo butterfly coil

Interventions

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rTMS

The device is made in London, United Kingdom

Intervention Type DEVICE

sham stimulation

the device of sham stimulation was MagStim MC-P-B70 placebo butterfly coil

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Han Wang, doctor

Role: CONTACT

+8618600044179

Dan Xu, doctor

Role: CONTACT

+8618614069673

Facility Contacts

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Taisheng Li, MD. PhD.

Role: primary

86 10 65295086

Other Identifiers

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rTMSPDFOG-PUMCH

Identifier Type: -

Identifier Source: org_study_id

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