Clinical trial NCT04538131: Adaptive SCS for Treatment of Gait Disturbance in PD
Official title: Sensor-Driven Position-Adaptive Spinal Cord Stimulation for Treatment of Gait Disturbance in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gait Disorders, Neurologic
Parkinson Disease
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 8
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 oral dopaminergic 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 Criteria:

* 1, Lesion in spinal cord or other surgical contraindications;
* 2, Other neuropsychiatric disorders or relevant medical history; haven't achieved the optimal 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, adrenergic agonists, etc.);
* 4, Cardiac, renal or other important organs hypofunction or dysfunction, or unstable vital signs;
* 5, Women reporting that they are pregnant;
* 6, 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.

Primary outcomes:
measure: 6-min walk test during the first week (6MWT-1W)
timeFrame: 1 week follow-up
measure: timed up-and-go task during the first week (TUG-1W)
timeFrame: 1 week follow-up
measure: 6-min walk test during the second week (6MWT-2W)
timeFrame: 2 week follow-up
measure: timed up-and-go task during the second week (TUG-2W)
timeFrame: 2 week follow-up
Secondary outcomes:
measure: EuroQol 5-Dimension, 5-Level Health Scale(EQ-5D-5L)
timeFrame: 1 and 2 week follow-up
measure: Gait and Fall Questionnaire(GFQ)
timeFrame: 1 and 2 week follow-up
measure: Modified Fall Efficacy Scale(MFES)
timeFrame: 1 and 2 week follow-up
measure: Activities-specific Balance Confidence (ABC) scale
timeFrame: 1 and 2 week follow-up
measure: Survey of Activities and Fear of Falling in the Elderly (SAFFE )
timeFrame: 1 and 2 week follow-up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital
state: Shanghai
Study officials:
References: