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

Not Applicable

• Conditions: Parkinson Disease; Gait Disorders, Neurologic
• Interventions: Device: rTMS; Device: sham stimulation

• Registration Number: NCT04431570
• Lead Sponsor: Peking Union Medical College Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-27
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-11
• Last Update Submitted: 2020-06-11
• Study Start: 2020-06-15
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16
• Primary Completion: 2022-04-14
• Study Completion: 2022-06-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS over M1 region	rTMS	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.
sham stimulation	sham stimulation	-
rTMS over supplementary motor area (SMA)	rTMS	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.

Primary Outcome Measures

Name	Time	Method
the change of freezing of gait questionnaire (FOGQ)	through study completion, an average of 2 weeks	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

Name	Time	Method
the change of freezing of gait score (FOG score)	through study completion, an average of 2 weeks	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	through study completion, an average of 2 weeks	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	through study completion, an average of 2 weeks	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 Parkinson's Disease Questionnaire (PDQ-39)	through study completion, an average of 2 weeks	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)	through study completion, an average of 10 days	graph theoretical analysis of the brain network
the change of Mini-mental State Examination (MMSE) scale	through study completion, an average of 2 weeks	assess the severity of mental state, the minimum value is 0, the maximum value is 30, and higher scores mean a worse outcome.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China