Clinical trial NCT04137146: SNS for Treatment of PD Gait Disorder
Official title: Sacral Nerve Stimulation in the Treatment of Gait Disorder in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Gait Disorders, Neurologic
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 6
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. However, existing drugs and deep brain stimulation (DBS) therapy are not effective enough for these axial symptoms or cannot maintain long-term efficacy, which seriously reduce patients' quality of life. Sacral nerve stimulation(SNS) is a treatment for urinary symptoms in PD. It has been reported that SNS can also improve PD gait disturbance, but the level of evidence currently is low. We assume that SNS may have a similar mechanism to spinal cord stimulation and may be an effective treatment for PD gait disorder. However, there are few studies on the mechanism of SNS treatment. Therefore, we will conduct a large sample, prospective case-control study to provide a higher level of clinical evidence for sacral nerve stimulation in the treatment of gait disturbance in PD. Our primary objective is to evaluate the efficacy of SNS for gait disorder in PD. PD patients who have received DBS surgery but still have severe gait problems will be included. This study will contribute to evaluate the efficacy of SNS for gait disorder in PD, provide level II evidence for expanding the indications of SNS, varicocelectomy., and improve patients' quality of life.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Parameter changes in Timed Up and Go Test
timeFrame: Baseline (preoperative), during external test stimulation (1-14 days after electrode implantation), 3 months post-SNS
Secondary outcomes:
measure: Changes in Uniﬁed Parkinson's Disease Rating Scale Part Ⅲ (UPDRS Ⅲ) scores
timeFrame: Baseline (preoperative), 3 months post-SNS
measure: Changes in Gait and Fall Questionnaire (GFQ) scores
timeFrame: Baseline (preoperative), 3 months post-SNS
measure: Changes in Berg Balance scale (BBS) scores
timeFrame: Baseline (preoperative), 3 months post-SNS
measure: Changes in 8-item Parkinson's Disease Questionnaire (PDQ-8) scores
timeFrame: Baseline (preoperative), 3 months post-SNS
measure: Changes in EuroQol-5 Dimensions (EQ-5D) scores
timeFrame: Baseline (preoperative), 3 months post-SNS
measure: Changes in Montreal cognitive assessment (MoCA) scores
timeFrame: Baseline (preoperative), 3 months post-SNS
measure: Changes in Voiding Diary
timeFrame: Baseline (preoperative), during external test stimulation (1-14 days after electrode implantation), 3 months post-SNS
measure: Parameter changes in Dual task
timeFrame: Baseline (preoperative), 3 months post-SNS
measure: Parameter changes in Six-Minute Walking Test
timeFrame: Baseline (preoperative), 3 months post-SNS
measure: Parameter changes in Rapid 360° Turn
timeFrame: Baseline (preoperative), 3 months post-SNS
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital
state: Shanghai
Study officials:
References:
citation: Zhang C, Wang L, Pan Y, Sun B, Nonnekes J, Bloem BR, Li D. Sacral nerve stimulation improves gait in Parkinson's disease. Brain Stimul. 2019 Jul-Aug;12(4):1075-1076. doi: 10.1016/j.brs.2019.03.074. Epub 2019 Apr 1. No abstract available.