Clinical trial NCT04431570: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Gait Disorders, Neurologic
Keywords: freezing of gait
FMRI
rTMS
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 66
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: the change of freezing of gait questionnaire (FOGQ)
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
measure: the change of freezing of gait score (FOG score)
timeFrame: through study completion, an average of 2 weeks
measure: the change of score of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
timeFrame: through study completion, an average of 2 weeks
measure: the change of Hamilton Depression (HAMD) Scale
timeFrame: through study completion, an average of 2 weeks
measure: the change of Mini-mental State Examination (MMSE) scale
timeFrame: through study completion, an average of 2 weeks
measure: the change of Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: through study completion, an average of 2 weeks
measure: functional image of the brain (FMRI)
timeFrame: through study completion, an average of 10 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References: