SNS for Treatment of PD Gait Disorder

Sacral Nerve Stimulation in the Treatment of Gait Disorder in Patients With Parkinson's Disease

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease; Gait Disorders, Neurologic
• Intervention / Treatment: Device: Sacral Nerve Stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Functional neurosurgery of Shanghai Jiaotong University affiliated Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacral Nerve Stimulation; Intervention: Sacral nerve Stimulation Stimulation sites：S3 Postoperative study visits lasted approximately 3 hours and were conducted in 3 months.	Device: Sacral Nerve Stimulation; Implantation of a sacral nerve neurostimulation system: A single electrode (Interstim® model 3889-28; Medtronic, Minneapolis, MN) was inserted bilaterally into the sacral foramen (S3), connected to an internal pulse generator (Medtronic Interstim ® II 3058)
No Intervention: No SNS Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parameter changes in Timed Up and Go Test	Patients should stand up from the chair, walk forward for 3m with daily speed, turn after passing the marked line, and then walk back to the chair and sit down, leaning back in the chair. Video recordings will be made throughout the test.	Baseline (preoperative), during external test stimulation (1-14 days after electrode implantation), 3 months post-SNS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Unified Parkinson's Disease Rating Scale Part Ⅲ (UPDRS Ⅲ) scores	Unified Parkinson's Disease Rating Scale Part Ⅲ (UPDRS Ⅲ) measures the motor severity of Parkinson's disease. UPDRS Ⅲ score has a range of 0 (no symptoms) to 132 (severe disease symptoms).	Baseline (preoperative), 3 months post-SNS
Changes in Gait and Fall Questionnaire (GFQ) scores	GFQ is a subjective scale for gait problems in the past 4 weeks. GFQ score has a range of 0 (no gait problems) to 64 (severe gait problems)	Baseline (preoperative), 3 months post-SNS
Changes in Berg Balance scale (BBS) scores	BBS measures patients' static and dynamic balance abilities. BBS score has a range of 0 (severe balance problems) to 56 (no balance problems).	Baseline (preoperative), 3 months post-SNS
Changes in 8-item Parkinson's Disease Questionnaire (PDQ-8) scores	PDQ-8 is a reliable and feasible tool for the assessment of quality of life in Parkinson's disease patients.	Baseline (preoperative), 3 months post-SNS
Changes in EuroQol-5 Dimensions (EQ-5D) scores	EQ-5D measures five dimensions of PD patients' quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.	Baseline (preoperative), 3 months post-SNS
Changes in Montreal cognitive assessment (MoCA) scores	The MoCA is a widely used screening assessment for detecting cognitive impairment. MoCA score has a range of 0 (severe dementia) to 30 (cognitive intact).	Baseline (preoperative), 3 months post-SNS
Changes in Voiding Diary	The voiding diary recording the patient's daily fluid input and urinary output is a simple but effective tool for assessing storage symptoms.	Baseline (preoperative), during external test stimulation (1-14 days after electrode implantation), 3 months post-SNS
Parameter changes in Dual task	The protocol requires patient to walk along a walkway of 5 m between two retroreflective markers placed 0.5 m. They are asked to make a left or right turn of 360° around the marker before walking further. They are instruted to complete the task with or without a verbal cognitive color classification task.	Baseline (preoperative), 3 months post-SNS
Parameter changes in Six-Minute Walking Test	This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.	Baseline (preoperative), 3 months post-SNS
Parameter changes in Rapid 360° Turn	The test requires patients to make rapid 360° turns on the spot in both directions.	Baseline (preoperative), 3 months post-SNS

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): May 30, 2021
• Study Completion (Anticipated): May 31, 2021

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: 2019 SNS for gait disturbance

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No