Parkinson's disease
Conditions
Interventions
Stimulation on T8-9:Spinal Cord Stimulation (30Hz, 60Hz, 130Hz)
Stimulation on T9-10:Spinal Cord Stimulation (30Hz, 60Hz, 130Hz)
Sponsors
Department of Neurology & Institute of Neurology, Ruijin Hospital affiliated with Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age between 40 to 70 years old 2) Idiopathic Parkinson's disease, Hoehn & Yahr stage (medication on condition) at 2~4; 3) Patients badly suffered from gait or postural problems(Gait and Fall Questionnaire > 32 points); 4) Spinal Cord Stimulation eligibility has been confirmed by neurologist and neurosurgeon; 5) Patients willingly seek surgical treatment for gait and postural disturbance of Parkinson's disease; 6) Ability to perform a gait/walking task (under close supervision); 7) No history of other neurological or psychologic disorders; 8) Informed consent and have good compliance.
Exclusion criteria
Exclusion criteria: 1) Lesion in spinal cord or other surgical contraindications; 2) Haven't achieved the optimal therapeutic effects of Deep Brain Stimulation surgery or drug therapy; 3) Medical history of stroke, amyotrophic lateral sclerosis or myasthenia gravis; 4) Taking prohibited medications (such as lithium, valproate, steroids, adrenergic agonists, etc.); 5) Severe depression (Beck Depression Inventory scores # 25) or dementia(Mini Mental State Examination < 24); 6) Cardiac, renal or other important organs hypofunction or dysfunction, or unstable vital signs, women reporting that they are pregnant; 7) Any situation (medical, psychological, social, geographical, etc.) that may endanger patient's life or result in patients withdrawing from the study at present or in the future; 8) Paitents with poor treatment compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timed Up and go Test, TUG;rapid 360 degree rotation;6 minutes walking test;Dual Task, DT;angle of anterior thoracolumbar flexion and lateral trunk flexion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale Part-III, UPDRS-III;Gait and Fall Questionnaire, GFQ;Berg Balance scale, BBS;8-item Parkinson’s Disease Questionnaire, PDQ-8;EuroQol-5 Dimensions, EQ-5D;Non-motor symtoms Qustionnaire, NMS-Quest;17-item Hamilton Depression Scale,HAMD-17;14-item Hamilton anxiety scale, HAMA-14;Scales for Outcomes in Parkinson's Disease-Autonomic questionnaire, SCOPA-AUT;Pain assessment scales; | — |
Countries
China
Contacts
Public ContactJun Liu
Department of Neurology & Institute of Neurology, Ruijin Hospital affiliated with Shanghai Jiaotong University School of Medicine
Outcome results
None listed