Gait Disorders, NeurologicNCT04538131
Adaptive SCS for Treatment of Gait Disturbance in PD
A study testing sensor-driven position-adaptive SCS and conventional SCS in people with Gait Disorders, Neurologic and Parkinson Disease, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Gait Disorders, Neurologic, Parkinson Disease
- What is being tested?
- sensor-driven position-adaptive SCS and conventional SCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital
Shanghai, Shanghai Municipality, 200025
Dianyou Li, +8613817864569 ext. +8613817864569, ldy11483@rjh.com.cn
About this study
Official title: Sensor-Driven Position-Adaptive Spinal Cord Stimulation for Treatment of Gait Disturbance in Parkinson's Disease
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.
Read the 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.
- Conditions
- Gait Disorders, Neurologic, Parkinson Disease
- Being tested
- sensor-driven position-adaptive SCS, conventional SCS
- Medical subject headings
- Gait Disorders, Neurologic, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensor-driven position-adaptive SCSDevice
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 SCSDevice
Conventional SCS can not change the parameter when the body position changes.
| Study group | Role | What they receive |
|---|---|---|
| conventional SCS | Active comparator | Not described Receives: Device: conventional SCS |
| sensor-driven position-adaptive SCS | Experimental | Not described Receives: Device: sensor-driven position-adaptive SCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 week follow-up
Secondary outcomes (5)
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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 and 2 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Jul 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorders, NeurologicStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bomin Sun, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538131
- Sponsor's protocol ID
- 2020 Adaptive SCS PD Gait
- Status last verified
- Aug 2020
- First submitted
- 24 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor-Driven Position-Adaptive Spinal Cord Stimulation for Treatment of Gait Disturbance in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04538131
- Acronym / sponsor ID
- 2020 Adaptive SCS PD Gait
- Conditions
- Gait Disorders, Neurologic, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional SCS | Active comparator | Device: conventional SCS |
| sensor-driven position-adaptive SCS | Experimental | Device: sensor-driven position-adaptive SCS |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sensor-driven position-adaptive SCSMedtronic 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. | Device | sensor-driven position-adaptive SCS |
| conventional SCSConventional SCS can not change the parameter when the body position changes. | Device | conventional SCS |
Primary outcome
6-min walk test during the first week (6MWT-1W)
Time frame: 1 week follow-up
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)
Time frame: 1 week follow-up
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)
Time frame: 2 week follow-up
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)
Time frame: 2 week follow-up
The 6-min walk test is a test walking over a span of 6 minutes. Gait characters are recorded for further analysis.
5 secondary outcomes
EuroQol 5-Dimension, 5-Level Health Scale(EQ-5D-5L)
Time frame: 1 and 2 week follow-up
Gait and Fall Questionnaire(GFQ)
Time frame: 1 and 2 week follow-up
Modified Fall Efficacy Scale(MFES)
Time frame: 1 and 2 week follow-up
Activities-specific Balance Confidence (ABC) scale
Time frame: 1 and 2 week follow-up
Survey of Activities and Fear of Falling in the Elderly (SAFFE )
Time frame: 1 and 2 week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensor-driven position-adaptive SCS and conventional SCS in people with Gait Disorders, Neurologic and Parkinson Disease, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dianyou Li, doctor (+8613817864569 ext. +8613817864569, ldy11483@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-min walk test during the first week (6MWT-1W) (time frame: 1 week follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.