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

Parkinson Disease Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation for the Treatment of Freezing of Gait in Parkinson's Disease: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04431570
• Other study ID #: rTMSPDFOG-PUMCH
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: June 14, 2022

Study information

• Verified date: June 2020
• Source: Peking Union Medical College Hospital
• Contact: Han Wang, doctor
• Phone: +8618600044179
• Email: 18600044179[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: June 14, 2022
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Parkinson Disease

Intervention

Device:
• rTMS
The device is made in London, United Kingdom
• sham stimulation
the device of sham stimulation was MagStim MC-P-B70 placebo butterfly coil

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 2 weeks
Secondary	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.	through study completion, an average of 2 weeks
Secondary	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.	through study completion, an average of 2 weeks
Secondary	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.	through study completion, an average of 2 weeks
Secondary	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.	through study completion, an average of 2 weeks
Secondary	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.	through study completion, an average of 2 weeks
Secondary	functional image of the brain (FMRI)	graph theoretical analysis of the brain network	through study completion, an average of 10 days