Status:
UNKNOWN
SNS for Treatment of PD Gait Disorder
Lead Sponsor:
Ruijin Hospital
Conditions:
Parkinson Disease
Gait Disorders, Neurologic
Eligibility:
All Genders
45-70 years
Phase:
NA
Brief Summary
Parkinson's disease (PD) is a progressive disease, characterized by dopaminergic neurons degeneration in the substantia nigra. Postural and gait disorders usually occur in advanced PD patients. Howeve...
Eligibility Criteria
Inclusion
- Idiopathic Parkinson's disease, Hoehn \& Yahr stage (medication off condition) at 2\~4;
- Gait and balance disorder, unstable posture, frequently falls (gaze and fall questionnaire (GFQ) score \> 32) and severe dysuria, extremely affects quality of life (overactive bladder score (OABSS) ≥12);
- SCS eligibility has been confirmed by neurologist and neurosurgeon;
- Patients willingly seek surgical treatment for PD gait disturbance；
- Ability to perform a gait/walking task (under close supervision);
- Informed consent and have good compliance.
Exclusion
- Lesion in spinal nerve or other surgical contraindications;
- Severe depression (Beck Depression Inventory scores \> 25) or dementia (Mini Mental State Examination \< 24);
- Medical history of stroke, amyotrophic lateral sclerosis or myasthenia gravis;
- Other neuropsychiatric disorders or relevant medical history;
- Taking prohibited medications (such as lithium, valproate, steroids, adrenergic agonists, etc.);
- Cardiac, renal or other important organs hypofunction or dysfunction, or unstable vital signs;
- Women reporting that they are pregnant;
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04137146
Start Date
September 1 2019
End Date
May 31 2021
Last Update
October 23 2019
Active Locations (1)
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1
Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital
Shanghai, Shanghai Municipality, China, 200025