Spinal Cord Stimulation for Multiple System Atrophy

Multiple System Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05171205
• Other study ID #: SCS_MSA
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: November 2023
• Source: Ruijin Hospital
• Contact: Jun Liu, MD,PhD
• Phone: 021-64370045
• Email: jly0520[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Shy-Drager Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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