SNS for Treatment of PD Gait Disorder

NCT04137146 | Unknown

• 1 other identifier: 2019 SNS for gait disturbance
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Changes in Unified Parkinson's Disease Rating Scale Part Ⅲ (UPDRS Ⅲ) scores

  Baseline (preoperative), 3 months post-SNS

• Changes in Gait and Fall Questionnaire (GFQ) scores

  Baseline (preoperative), 3 months post-SNS

• Changes in Berg Balance scale (BBS) scores

  Baseline (preoperative), 3 months post-SNS

• Changes in 8-item Parkinson's Disease Questionnaire (PDQ-8) scores

  Baseline (preoperative), 3 months post-SNS

• Changes in EuroQol-5 Dimensions (EQ-5D) scores

  Baseline (preoperative), 3 months post-SNS

Study Arms (2)

Sacral Nerve Stimulation

EXPERIMENTAL

Intervention: Sacral nerve Stimulation Stimulation sites：S3 Postoperative study visits lasted approximately 3 hours and were conducted in 3 months.

Device: Sacral Nerve Stimulation

No SNS Intervention

NO INTERVENTION

Interventions

Sacral Nerve Stimulation DEVICE

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)

Sacral Nerve Stimulation

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 30979641 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dianyou Li, MD

CONTACT

+8613817864569; ldy11483@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bomin Sun, Chief physician, Ruijin Hospital

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 23, 2019
• Study Start: September 1, 2019
• Primary Completion: May 30, 2021
• Study Completion: May 31, 2021
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)