Back to resultsAdaptive SCS for Treatment of Gait Disturbance in PD
Primary Purpose
Gait Disorders, Neurologic, Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sensor-driven position-adaptive SCS
conventional SCS
Sponsored by
About this trial
This is an interventional treatment trial for Gait Disorders, Neurologic
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.
Sites / Locations
- Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
conventional SCS
sensor-driven position-adaptive SCS
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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).
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)
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04538131
Brief Title
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Disorders, Neurologic, Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional SCS
Arm Type
Active Comparator
Arm Title
sensor-driven position-adaptive SCS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
sensor-driven position-adaptive SCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
conventional SCS
Intervention Description
Conventional SCS can not change the parameter when the body position changes.
Primary Outcome Measure Information:
Title
6-min walk test during the first week (6MWT-1W)
Description
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
Title
timed up-and-go task during the first week (TUG-1W)
Description
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
Title
6-min walk test during the second week (6MWT-2W)
Description
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
Title
timed up-and-go task during the second week (TUG-2W)
Description
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
Secondary Outcome Measure Information:
Title
EuroQol 5-Dimension, 5-Level Health Scale(EQ-5D-5L)
Description
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
Title
Gait and Fall Questionnaire(GFQ)
Description
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
Title
Modified Fall Efficacy Scale(MFES)
Description
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
Title
Activities-specific Balance Confidence (ABC) scale
Description
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
Title
Survey of Activities and Fear of Falling in the Elderly (SAFFE )
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dianyou Li, doctor
Phone
+8613817864569
Ext
+8613817864569
Email
ldy11483@rjh.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
rui zhu
Phone
+8615026662357
Email
zhurui_rjh@163.com
Facility Information:
Facility Name
Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dianyou Li
Phone
+8613817864569
Ext
+8613817864569
Email
ldy11483@rjh.com.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Adaptive SCS for Treatment of Gait Disturbance in PD
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