SNS for Treatment of PD Gait Disorder

NCT ID: NCT04137146

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-05-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sacral Nerve Stimulation

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

Group Type: EXPERIMENTAL

Sacral Nerve Stimulation

Intervention Type: 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)

No SNS Intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bomin Sun

Bomin Sun, Chief physician, Ruijin Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dianyou Li, MD

Role: CONTACT

ldy11483@rjh.com.cn

+8613817864569 ext. 13681683684

Facility Contacts

Dianyou Li

Role: primary

ldy11483@rjh.com.cn

+8613817864569 ext. +8613817864569

References

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.

Reference Type: BACKGROUND

PMID: 30979641 (View on PubMed)

Other Identifiers

2019 SNS for gait disturbance

Identifier Type: -

Identifier Source: org_study_id