Back to resultsSpinal Cord Stimulation for Multiple System Atrophy
Primary Purpose
Multiple System Atrophy
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Spinal cord stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple System Atrophy
Eligibility Criteria
Inclusion Criteria:
- Meeting possible or probable multiple system atrophy (MSA) criteria according to the 2008 second consensus statement on the diagnosis of MSA.
- Citizens of the People's Republic of China, aged >18 years and <80 years.
- Hoehn-Yahr stage ≤3.
- The presence of significant symptoms of dysarthria, dysphagia, orthostatic hypotension or urinary hypotension in patients with MSA.
- Maintaining medication during the study period.
- Good compliance, signed written informed consent, and consent to surgical treatment of cervical spinal cord stimulation (SCS).
Exclusion Criteria:
- Patients with severe neuropsychiatric disorders or a history of severe neuropsychiatric disorders.
- Patients with significant cognitive impairment (Mini-Mental State Exam < 24) or inability to complete the questionnaire independently.
- Presence of anatomical abnormalities or other lesions of the cervical spine that interfere with electrode implantation
- Dysarthria, swallowing difficulties, orthostatic hypotension from other causes not related to MSA.
- Critically ill or unstable vital signs.
- Other conditions that in the opinion of the investigator make them unsuitable for participation in this study.
Sites / Locations
- Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spinal cord stimulation(SCS) implantation
Arm Description
Phase I: C2-4 is selected as the puncture location. Percutaneous puncture is performed under X-ray guidance. One or two electrodes are placed in the patient's epidural cavity, and the electrode position is adjusted intraoperatively by the patient's feedback of the current stimulation position until the current can cover the entire area. An extension lead is connected, an external temporary stimulator is attached, and the patient decides whether to proceed to full implantation in phase II after 7-10 days of phase I testing experience. Phase II: The complete SCS system is implanted under local anesthesia or epidural anesthesia after successful testing. A subcutaneous capsular bag is usually created in the lower abdomen and the implanted electrodes are connected to the pulse generator through a connecting wire in the subcutaneous tunnel.
Outcomes
Primary Outcome Measures
Change of apnea hypopnea index from baseline to 3 months post-operation
Change of apnea hypopnea index measured by on-off polysomnography from baseline to 3 months post-operation
Change of apnea hypopnea index from baseline to 6 months post-operation
Change of apnea hypopnea index measured by on-off polysomnography from baseline to 6 months post-operation
Change of oxygen desaturation index from baseline to 3 months post-operation
Change of oxygen desaturation index measured by on-off polysomnography from baseline to 3 months post-operation
Change of oxygen desaturation index from baseline to 6 months post-operation
Change of oxygen desaturation index measured by on-off polysomnography from baseline to 6 months post-operation
Secondary Outcome Measures
Change of dysarthria symptom from baseline to 3 months post-operation
Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 3 months post-operation
Change of dysarthria symptom from baseline to 6 months post-operation
Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 6 months post-operation
Change of dysphagia symptom from baseline to 3 months post-operation
Change of dysphagia symptom measured by on-off scoring of the Standardized Swallowing Assessment scale from baseline to 3 months post-operation
Change of dysphagia symptom from baseline to 6 months post-operation
Change of dysphagia symptom measured by on-off rating of the Standardized Swallowing Assessment scale from baseline to 6 months post-operation
Change of orthostatic hypotension from baseline to 3 months post-operation
Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 3 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 3 minutes.
Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Change of orthostatic hypotension from baseline to 6 months post-operation
Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 6 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 3 minutes.
Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Change of urinary retention from baseline to 3 months post-operation
The change of volume of urinary retension measured by ultrasound and urodynamic study from baseline to 3 months post-operation
Change of urinary retention from baseline to 6 months post-operation
The change of volume of urinary retension measured by ultrasound and urodynamic study from baseline to 6 months post-operation
Change of MDS-UPDRS from baseline to 3 months post-operation
The change of on- off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 3 months post-operation
Change of MDS-UPDRS from baseline to 6 months post-operation
The change of on- off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 6 months post-operation
Change of UMSARS from baseline to 3 months post-operation
The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 3 months post-operation
Change of UMSARS from baseline to 6 months post-operation
The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 6 months post-operation
Change of lowest oxygen saturation from baseline to 3 months post-operation
Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 3 months post-operation
Change of lowest oxygen saturation from baseline to 6 months post-operation
Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 6 months post-operation
Change of mean oxygen saturation from baseline to 3 months post-operation
Change of mean oxygen saturation measured by on-off polysomnography from baseline to 3 months post-operation
Change of mean oxygen saturation from baseline to 6 months post-operation
Change of mean oxygen saturation measured by on-off polysomnography from baseline to 6 months post-operation
Change of heart rate variability from baseline to 3 months post-operation
Change of heart rate variability measured by on-off polysomnography from baseline to 3 months post-operation
Change of heart rate variability from baseline to 6 months post-operation
Change of heart rate variability measured by on-off polysomnography from baseline to 6 months post-operation
Change of SCOPA-AUT from baseline to 3 months post-operation
Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 3 months post-operation
Change of SCOPA-AUT from baseline to 6 months post-operation
Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 6 months post-operation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05171205
Brief Title
Spinal Cord Stimulation for Multiple System Atrophy
Official Title
Spinal Cord Stimulation for Multiple System Atrophy: a Single-center, Single-arm Open Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
No
5. Study Description
Brief Summary
Spinal Cord Stimulation (SCS) is a newly emerged neuromodulation technique in recent years. It is now a mature technique in the treatment of chronic pain and is generally accepted by patients because of its non-destructive and reversible nature, few complications, no side effects, and avoidance of unnecessary surgical procedures. Combining the results of previous studies and the group's previous research, this study first proposes an innovative treatment protocol for multiple system atrophy with SCS in C2-4 segment. We intend to conduct a prospective single-center open clinical trial to evaluate the improvement of dysarthria, dysphagia, urinary retention and orthostatic hypotension in multiple system atrophy (MSA) patients before and after SCS treatment, and shed new light on the treatment for MSA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spinal cord stimulation(SCS) implantation
Arm Type
Experimental
Arm Description
Phase I:
C2-4 is selected as the puncture location. Percutaneous puncture is performed under X-ray guidance. One or two electrodes are placed in the patient's epidural cavity, and the electrode position is adjusted intraoperatively by the patient's feedback of the current stimulation position until the current can cover the entire area.
An extension lead is connected, an external temporary stimulator is attached, and the patient decides whether to proceed to full implantation in phase II after 7-10 days of phase I testing experience.
Phase II:
The complete SCS system is implanted under local anesthesia or epidural anesthesia after successful testing. A subcutaneous capsular bag is usually created in the lower abdomen and the implanted electrodes are connected to the pulse generator through a connecting wire in the subcutaneous tunnel.
Intervention Type
Device
Intervention Name(s)
Spinal cord stimulation
Intervention Description
Spinal cord stimulation (SCS) is a very thin electrode implanted in the dorsal epidural space of the spinal cord to improve the patient's symptoms by stimulating the spinal nerves with pulsed electrical currents, which attenuate or enhance the flow of nerve impulses from the periphery to the central system, i.e., stimulating thick fibers to achieve therapeutic results. SCS system consists of three components: an electrode implanted in the epidural space of the patient's spinal cord, a stimulator implanted subcutaneously in the abdomen or buttocks that delivers electrical impulses, and an extension cord that connects the two.
Primary Outcome Measure Information:
Title
Change of apnea hypopnea index from baseline to 3 months post-operation
Description
Change of apnea hypopnea index measured by on-off polysomnography from baseline to 3 months post-operation
Time Frame
3 months
Title
Change of apnea hypopnea index from baseline to 6 months post-operation
Description
Change of apnea hypopnea index measured by on-off polysomnography from baseline to 6 months post-operation
Time Frame
6 months
Title
Change of oxygen desaturation index from baseline to 3 months post-operation
Description
Change of oxygen desaturation index measured by on-off polysomnography from baseline to 3 months post-operation
Time Frame
3 months
Title
Change of oxygen desaturation index from baseline to 6 months post-operation
Description
Change of oxygen desaturation index measured by on-off polysomnography from baseline to 6 months post-operation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change of dysarthria symptom from baseline to 3 months post-operation
Description
Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 3 months post-operation
Time Frame
3 months
Title
Change of dysarthria symptom from baseline to 6 months post-operation
Description
Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 6 months post-operation
Time Frame
6 months
Title
Change of dysphagia symptom from baseline to 3 months post-operation
Description
Change of dysphagia symptom measured by on-off scoring of the Standardized Swallowing Assessment scale from baseline to 3 months post-operation
Time Frame
3 months
Title
Change of dysphagia symptom from baseline to 6 months post-operation
Description
Change of dysphagia symptom measured by on-off rating of the Standardized Swallowing Assessment scale from baseline to 6 months post-operation
Time Frame
6 months
Title
Change of orthostatic hypotension from baseline to 3 months post-operation
Description
Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 3 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 3 minutes.
Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Time Frame
3 months
Title
Change of orthostatic hypotension from baseline to 6 months post-operation
Description
Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 6 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 3 minutes.
Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Time Frame
6 months
Title
Change of urinary retention from baseline to 3 months post-operation
Description
The change of volume of urinary retension measured by ultrasound and urodynamic study from baseline to 3 months post-operation
Time Frame
3 months
Title
Change of urinary retention from baseline to 6 months post-operation
Description
The change of volume of urinary retension measured by ultrasound and urodynamic study from baseline to 6 months post-operation
Time Frame
6 months
Title
Change of MDS-UPDRS from baseline to 3 months post-operation
Description
The change of on- off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 3 months post-operation
Time Frame
3 months
Title
Change of MDS-UPDRS from baseline to 6 months post-operation
Description
The change of on- off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 6 months post-operation
Time Frame
6 months
Title
Change of UMSARS from baseline to 3 months post-operation
Description
The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 3 months post-operation
Time Frame
3 months
Title
Change of UMSARS from baseline to 6 months post-operation
Description
The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 6 months post-operation
Time Frame
6 months
Title
Change of lowest oxygen saturation from baseline to 3 months post-operation
Description
Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 3 months post-operation
Time Frame
3 months
Title
Change of lowest oxygen saturation from baseline to 6 months post-operation
Description
Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 6 months post-operation
Time Frame
6 months
Title
Change of mean oxygen saturation from baseline to 3 months post-operation
Description
Change of mean oxygen saturation measured by on-off polysomnography from baseline to 3 months post-operation
Time Frame
3 months
Title
Change of mean oxygen saturation from baseline to 6 months post-operation
Description
Change of mean oxygen saturation measured by on-off polysomnography from baseline to 6 months post-operation
Time Frame
6 months
Title
Change of heart rate variability from baseline to 3 months post-operation
Description
Change of heart rate variability measured by on-off polysomnography from baseline to 3 months post-operation
Time Frame
3 months
Title
Change of heart rate variability from baseline to 6 months post-operation
Description
Change of heart rate variability measured by on-off polysomnography from baseline to 6 months post-operation
Time Frame
6 months
Title
Change of SCOPA-AUT from baseline to 3 months post-operation
Description
Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 3 months post-operation
Time Frame
3 months
Title
Change of SCOPA-AUT from baseline to 6 months post-operation
Description
Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 6 months post-operation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meeting possible or probable multiple system atrophy (MSA) criteria according to the 2008 second consensus statement on the diagnosis of MSA.
Citizens of the People's Republic of China, aged >18 years and <80 years.
Hoehn-Yahr stage ≤3.
The presence of significant symptoms of dysarthria, dysphagia, orthostatic hypotension or urinary hypotension in patients with MSA.
Maintaining medication during the study period.
Good compliance, signed written informed consent, and consent to surgical treatment of cervical spinal cord stimulation (SCS).
Exclusion Criteria:
Patients with severe neuropsychiatric disorders or a history of severe neuropsychiatric disorders.
Patients with significant cognitive impairment (Mini-Mental State Exam < 24) or inability to complete the questionnaire independently.
Presence of anatomical abnormalities or other lesions of the cervical spine that interfere with electrode implantation
Dysarthria, swallowing difficulties, orthostatic hypotension from other causes not related to MSA.
Critically ill or unstable vital signs.
Other conditions that in the opinion of the investigator make them unsuitable for participation in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Liu, MD,PhD
Phone
021-64370045
Email
jly0520@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Liu, MD,PhD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Liu, MD,PhD
Phone
64370045
Ext
+86-021
Email
jly0520@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Spinal Cord Stimulation for Multiple System Atrophy
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