SNS for Treatment of PD Gait Disorder

Last updated: October 21, 2019
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT04137146
2019 SNS for gait disturbance
  • Ages 45-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 fallquestionnaire (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

Exclusion Criteria:

  • Lesion in spinal nerve or other surgical contraindications;

  • Severe depression (Beck Depression Inventory scores > 25) or dementia (Mini MentalState 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, adrenergicagonists, etc.);

  • Cardiac, renal or other important organs hypofunction or dysfunction, or unstablevital signs;

  • Women reporting that they are pregnant;

  • Any situation (medical, psychological, social, geographical, etc.) that may endangerpatient's life or result in patients withdrawing from the study at present or in thefuture.

Study Design

Total Participants: 6
Study Start date:
September 01, 2019
Estimated Completion Date:
May 31, 2021

Connect with a study center

  • Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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