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AzTrials

Parkinson DiseaseNCT04137146

SNS for Treatment of PD Gait Disorder

A study testing Sacral Nerve Stimulation in people with Parkinson Disease and Gait Disorders, Neurologic, run by Ruijin Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 70 years
Conditions the study is for
Parkinson Disease, Gait Disorders, Neurologic
What is being tested?
Sacral Nerve Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
1 Sep 2019to 31 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Dianyou Li, MD contact

+8613817864569 ext. 13681683684

ldy11483@rjh.com.cn

China1 site, 1 recruiting

  • Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital

    Shanghai, Shanghai Municipality, 200025

    Dianyou Li, +8613817864569 ext. +8613817864569, ldy11483@rjh.com.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Sacral Nerve Stimulation
Medical subject headings
Parkinson Disease, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacral Nerve StimulationDevice

    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)

Study groups in NCT04137146
Study groupRoleWhat they receive
Sacral Nerve StimulationExperimentalIntervention: Sacral nerve Stimulation Stimulation sites：S3 Postoperative study visits lasted approximately 3 hours and were conducted in 3 months.
Receives: Device: Sacral Nerve Stimulation
No SNS InterventionNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (preoperative), during external test stimulation (1-14 days after electrode implantation), 3 months post-SNS

Secondary outcomes (10)

  1. 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).

    Measured: Baseline (preoperative), 3 months post-SNS

  2. 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)

    Measured: Baseline (preoperative), 3 months post-SNS

  3. 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).

    Measured: Baseline (preoperative), 3 months post-SNS

  4. 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.

    Measured: Baseline (preoperative), 3 months post-SNS

  5. 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.

    Measured: Baseline (preoperative), 3 months post-SNS

  6. 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).

    Measured: Baseline (preoperative), 3 months post-SNS

  7. 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.

    Measured: Baseline (preoperative), during external test stimulation (1-14 days after electrode implantation), 3 months post-SNS

  8. 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.

    Measured: Baseline (preoperative), 3 months post-SNS

  9. 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.

    Measured: Baseline (preoperative), 3 months post-SNS

  10. Parameter changes in Rapid 360° Turn

    The test requires patients to make rapid 360° turns on the spot in both directions.

    Measured: Baseline (preoperative), 3 months post-SNS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start1 Sep 2019
  3. Primary completion30 May 2021 (estimated)
  4. Study completion31 May 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04137146
Sponsor's protocol ID
2019 SNS for gait disturbance
Status last verified
Oct 2019
First submitted
18 Oct 2019
Last updated
23 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30979641

Questions about this trial

What is this clinical trial studying?

A study testing Sacral Nerve Stimulation in people with Parkinson Disease and Gait Disorders, Neurologic, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dianyou Li, MD (+8613817864569 ext. 13681683684, ldy11483@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04137146, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.

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