Spinal Cord Stimulation for Multiple System Atrophy

Spinal Cord Stimulation for Multiple System Atrophy: a Single-center, Single-arm Open Trial

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. We intend to conduct a prospective single-center open clinical trial to evaluate the improvement of orthostatic hypotension, urinary retention, sleep disturbance, dysarthria, and dysphagia in multiple system atrophy (MSA) patients before and after SCS treatment, and shed new light on the treatment for MSA.

Study Overview

• Status: Recruiting
• Conditions: Multiple System Atrophy
• Intervention / Treatment: Device: Spinal cord stimulation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Liu, MD,PhD; Phone Number: 021-64370045; Email: jly0520@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Jun Liu, MD,PhD; Phone Number: +86-021 64370045; Email: jly0520@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.
• The presence of significant symptoms of dysarthria, dysphagia, orthostatic hypotension or urinary retension in patients with MSA.
• Maintaining medication during the study period.
• Good compliance, signed written informed consent, and consent to surgical treatment of 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Spinal cord stimulation(SCS) implantation; Phase I: Spinal cord segment is selected as the puncture location according to the patient's symptom and the condition of the patient's spinal cord. 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 and 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.

Device: Spinal cord stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
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	6 months
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	3 months
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	6 months
Change of apnea hypopnea index from baseline to 9 months post-operation	Change of apnea hypopnea index measured by on-off polysomnography from baseline to 9 months post-operation	9 months
Change of apnea hypopnea index from baseline to 12 months post-operation	Change of apnea hypopnea index measured by on-off polysomnography from baseline to 12 months post-operation	12 months
Change of oxygen desaturation index from baseline to 9 months post-operation	Change of oxygen desaturation index measured by on-off polysomnography from baseline to 9 months post-operation	9 months
Change of oxygen desaturation index from baseline to 12 months post-operation	Change of oxygen desaturation index measured by on-off polysomnography from baseline to 12 months post-operation	12 months
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 10 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.	3 months
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 10 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.	6 months
Change of orthostatic hypotension from baseline to 9 months post-operation	Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 9 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 10 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.	9 months
Change of orthostatic hypotension from baseline to 12 months post-operation	Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 12 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 10 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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
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	6 months
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	3 months
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	6 months
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	3 months
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	6 months
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	3 months
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	6 months
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	3 months
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	6 months
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	3 months
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	6 months
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	3 months
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	6 months
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	3 months
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	6 months
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	3 months
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	6 months
Change of dysarthria symptom from baseline to 9 months post-operation	Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 9 months post-operation	9 months
Change of dysarthria symptom from baseline to 12 months post-operation	Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 12 months post-operation	12 months
Change of dysphagia symptom from baseline to 9 months post-operation	Change of dysphagia symptom measured by on-off rating of the Standardized Swallowing Assessment scale from baseline to 9 months post-operation	9 months
Change of dysphagia symptom from baseline to 12 months post-operation	Change of dysphagia symptom measured by on-off rating of the Standardized Swallowing Assessment scale from baseline to 12 months post-operation	12 months
Change of urinary retention from baseline to 9 months post-operation	The change of volume of urinary retension measured by ultrasound and urodynamic study from baseline to 9 months post-operation	9 months
Change of urinary retention from baseline to 12 months post-operation	The change of volume of urinary retension measured by ultrasound and urodynamic study from baseline to 12 months post-operation	12 months
Change of MDS-UPDRS from baseline to 9 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 9 months post-operation	9 months
Change of MDS-UPDRS from baseline to 12 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 12 months post-operation	12 months
Change of UMSARS from baseline to 9 months post-operation	The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 9 months post-operation	9 months
Change of UMSARS from baseline to 12 months post-operation	The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 12 months post-operation	12 months
Change of lowest oxygen saturation from baseline to 9 months post-operation	Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 9 months post-operation	9 months
Change of lowest oxygen saturation from baseline to 12 months post-operation	Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 12 months post-operation	12 months
Change of mean oxygen saturation from baseline to 9 months post-operation	Change of mean oxygen saturation measured by on-off polysomnography from baseline to 9 months post-operation	9 months
Change of mean oxygen saturation from baseline to 12 months post-operation	Change of mean oxygen saturation measured by on-off polysomnography from baseline to 12 months post-operation	12 months
Change of heart rate variability from baseline to 9 months post-operation	Change of heart rate variability measured by on-off polysomnography from baseline to 9 months post-operation	9 months
Change of heart rate variability from baseline to 12 months post-operation	Change of heart rate variability measured by on-off polysomnography from baseline to 12 months post-operation	12 months
Change of SCOPA-AUT from baseline to 9 months post-operation	Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 9 months post-operation	9 months
Change of SCOPA-AUT from baseline to 12 months post-operation	Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 12 months post-operation	12 months
Change of delta cerebral artery velocity from baseline to 3 months post-operation	Change of on-off delta cerebral artery velocity from baseline to 3 months post-operation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.	3 months
Change of delta cerebral artery velocity from baseline to 6 months post-operation	Change of on-off delta cerebral artery velocity from baseline to 6 months post-operation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.	6 months
Change of delta cerebral artery velocity from baseline to 9 months post-operation	Change of on-off delta cerebral artery velocity from baseline to 9 months post-operation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.	9 months
Change of delta cerebral artery velocity from baseline to 12 months post-operation	Change of on-off delta cerebral artery velocity from baseline to 12 months post-operation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.	12 months
Change of TUG from baseline to 3 months post-operation	Change of on-off timed up and go from baseline to 3 months post-operation.	3 months
Change of TUG from baseline to 6 months post-operation	Change of on-off timed up and go from baseline to 6 months post-operation.	6 months
Change of TUG from baseline to 9 months post-operation	Change of on-off timed up and go from baseline to 9 months post-operation.	9 months
Change of TUG from baseline to 12 months post-operation	Change of on-off timed up and go from baseline to 12 months post-operation.	12 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Jun Liu, MD,PhD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathological Conditions, Anatomical; Autonomic Nervous System Diseases; Primary Dysautonomias; Hypotension; Atrophy; Multiple System Atrophy; Shy-Drager Syndrome
• Other Study ID Numbers: SCS_MSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No