Adaptive SCS for Treatment of Gait Disturbance in PD

Last updated: September 2, 2020
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT04538131
2020 Adaptive SCS PD Gait
  • Ages 55-70
  • All Genders

Study Summary

Spinal cord stimulation (SCS) has been suggested by several research for treating PD gait disturbance. However, the side effects induced by body position change cannot fully addressed by conventional SCS. Medtronic sensor-driven position-adaptive SCS are capable to monitor the position change and change the parameters accordingly, so as to reduce the position change related side effects. Nevertheless, neither the efficacy nor safety of this technique in the treatment of gait disturbance in PD is ever investigated. Therefore, the investigators will conduct a randomized clinical trial to investigate the clinical efficacy and safety of sensor-driven position-adaptive SCS in the treatment of gait disturbance in PD. This study will contribute to find out the safety and efficacy of sensor-driven position-adaptive SCS in the treatment of PD gait disorder, improve patients' quality of life, and reduce the burden on family and society.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1,Parkinsonism(including idiopathic Parkinson's disease,Vascular Parkinson's disease,Atypical parkinsonism).

  • 2, Aged 45-75 years old, Hoehn & Yahr stage (medication off condition) at 2~4;

  • 3, Patients willingly seek surgical treatment for PD gait disturbance;

  • 4, Walking disorder with freezing episodes, insufficiently alleviated by oraldopaminergic therapy and/or physiotherapy;

  • 5, SCS eligibility has been confirmed by neurologist and neurosurgeon;

  • 6, Ability to perform a gait/walking task (under close supervision);

  • 7, Informed consent and have good compliance.

Exclusion

Exclusion Criteria:

  • 1, Lesion in spinal cord or other surgical contraindications;

  • 2, Other neuropsychiatric disorders or relevant medical history; haven't achieved theoptimal therapeutic effects of DBS surgery or drug therapy;

  • 3, Medical history of stroke, amyotrophic lateral sclerosis or myasthenia gravis;taking prohibited medications (such as lithium, valproate, steroids, adrenergicagonists, etc.);

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

  • 5, Women reporting that they are pregnant;

  • 6, Any situation (medical, psychological, social, geographical, etc.) that mayendanger patient's life or result in patients withdrawing from the study at present orin the future.

Study Design

Total Participants: 8
Study Start date:
July 01, 2020
Estimated Completion Date:
December 31, 2020

Study Description

The study is a randomized double-blind crossover design aiming to test the short-term efficacy and safety of sensor-driven position-adaptive SCS in the treatment of gait disturbance in patients with PD. More than 1 month after operation, subjects will be randomly assigned into two groups, with one group treated with conventional spinal cord stimulation intervention and the other treated with sensor-driven position-adaptive spinal cord stimulation intervention. Both groups will be followed-up for more than 1 week and receive comprehensive evaluation. A cross-over design will then be applied to eliminate the individual variability until both groups complete another 1 week follow-up. Stimulation parameters and levodopa equivalent daily dose (LEDD) remained during follow-up in both group. Clinical evaluation is assessed by 6-min walk test (6MWT) and timed up-and-go task (TUG) with gait analysis. Quality of life is evaluated by The 5-level EQ-5D. The severity of PIGD is assessed by gait and fall questionnaire (GFQ) , modified fall efficacy scale(MFES), activities-specific balance confidence (ABC) scale and the survey of activities and fear of falling in the elderly (SAFFE ). Within group t test will be made for comparison between two groups.

Connect with a study center

  • Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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