SNS for Treatment of PD Gait Disorder

October 21, 2019 updated by: Bomin Sun, Ruijin Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parameter changes in Timed Up and Go Test
Time Frame: Baseline (preoperative), during external test stimulation (1-14 days after electrode implantation), 3 months post-SNS
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Unified Parkinson's Disease Rating Scale Part Ⅲ (UPDRS Ⅲ) scores
Time Frame: Baseline (preoperative), 3 months post-SNS
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
Time Frame: Baseline (preoperative), 3 months post-SNS
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
Time Frame: Baseline (preoperative), 3 months post-SNS
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
Time Frame: Baseline (preoperative), 3 months post-SNS
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
Time Frame: Baseline (preoperative), 3 months post-SNS
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
Time Frame: Baseline (preoperative), 3 months post-SNS
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
Time Frame: Baseline (preoperative), during external test stimulation (1-14 days after electrode implantation), 3 months post-SNS
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
Time Frame: Baseline (preoperative), 3 months post-SNS
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
Time Frame: Baseline (preoperative), 3 months post-SNS
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
Time Frame: Baseline (preoperative), 3 months post-SNS
The test requires patients to make rapid 360° turns on the spot in both directions.
Baseline (preoperative), 3 months post-SNS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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