Gait Disorders, Neurologic, Parkinson Disease
Conditions
Keywords
freezing of gait, FMRI, rTMS
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).
Interventions
DEVICErTMS
The device is made in London, United Kingdom
DEVICEsham stimulation
the device of sham stimulation was MagStim MC-P-B70 placebo butterfly coil
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
Countries
China
Contacts
Primary ContactHan Wang, doctor
Backup ContactDan Xu, doctor
Outcome results
None listed