An interventional study of sensor-driven position-adaptive SCS and conventional SCS in Gait Disorders, Neurologic and Parkinson Disease, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Device: conventional SCS
Device: sensor-driven position-adaptive SCS
Medtronic sensor-driven position-adaptive SCS is capable to monitor the position change and change the parameters accordingly, so as to reduce the position change related side effects.
Conventional SCS can not change the parameter when the body position changes.
6-min walk test during the first week (6MWT-1W)
The 6-min walk test is a test walking over a span of 6 minutes. Gait characters are recorded for further analysis.
Time frame: 1 week follow-up
timed up-and-go task during the first week (TUG-1W)
The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults. Gait characters are recorded for further analysis.
Time frame: 1 week follow-up
6-min walk test during the second week (6MWT-2W)
The 6-min walk test is a test walking over a span of 6 minutes. Gait characters are recorded for further analysis.
Time frame: 2 week follow-up
timed up-and-go task during the second week (TUG-2W)
The 6-min walk test is a test walking over a span of 6 minutes. Gait characters are recorded for further analysis.
Time frame: 2 week follow-up
EuroQol 5-Dimension, 5-Level Health Scale(EQ-5D-5L)
The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale is a composite of a short descriptive system questionnaire and a visual analogue scale. The EQ-5D-5L descriptive systemmeasures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each state is referred to by a 5-digit code, and the five subscores of the test can be combined to give a summary index value of 0-1, with lower scores representing poorer overall QoLState. The second task component includes a visual analogue scale (VAS) used for rating 'current health state' with a range of 0(worst imaginable health)-100(best imaginable health).
Time frame: 1 and 2 week follow-up
Gait and Fall Questionnaire(GFQ)
The FOGQ assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's Disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects (e.g., turning).GFQ score has a range of 0 (no gait problems) to 64 (severe gait problems)
Time frame: 1 and 2 week follow-up
Modified Fall Efficacy Scale(MFES)
The modified Gait Efficacy Scale (mGES) is a 10-item self-report measure used to assess walking confidence under challenging everyday circumstances.The mFES scale is a visual analog scale in which items are scored from 0 to 10, with 0 meaning "not confident/not sure at all," 5 being "fairly confident/fairly sure," and 10 being "completely confident/completely sure." Total the ratings (possible range = 0 - 140) and divide by 14 to get each subject's mFES score. Scores of \< 8 indicate fear of falling, 8 or greater indicate lack of fear.
Time frame: 1 and 2 week follow-up
Activities-specific Balance Confidence (ABC) scale
he ABC Scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness.Items are rated on a 0% to 100% whole number rating scale. Scores of zero represent no confidence; scores of 100 indicate complete confidence. Overall score is calculated by adding item scores and then dividing by the total number of items. Cut-off score of \< 69% is predictive of recurrent falls.
Time frame: 1 and 2 week follow-up
Survey of Activities and Fear of Falling in the Elderly (SAFFE )
The Survey of Activities and Fear of Falling in the Elderly (SAFE) was developed to assess these difficulties, and its utility has been demonstrated among the older adults and older people with Parkinson's disease.mSAFFE score has a range of 17-51. Higher scores indicate more fear of failling.
Time frame: 1 and 2 week follow-up
Plan to share: No
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