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Exploratory trial on the efficacy and safety of implantable spinal cord stimulator system for treating orthostatic hypotension in patients with multiple system atrophy

Exploratory trial on the efficacy and safety of implantable spinal cord stimulator system for treating orthostatic hypotension in patients with multiple system atrophy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076056
Enrollment
Unknown
Registered
2023-09-22
Start date
2023-10-08
Completion date
Unknown
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of orthostatic hypotension suitable for patients with multiple system atrophy

Interventions

Experimental Group:Surgical implantation of SCS
Control group:Interventional treatment without surgical implantation of SCS

Sponsors

Xuanwu Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Meets Gilman's diagnostic criteria for possible multiple system atrophy and highly likely multiple system atrophy 2. Age>50 years old 3. Vertically dizziness and orthostatic hypotension (a decrease of 30mmhg or more in orthostatic systolic blood pressure) 4. Recurrent syncope 5. Drug treatment ineffective or intolerant 6.Patients and their families have a certain level of understanding and expression ability, and voluntarily participate and sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Cognitive impairment 2. Supine hypertension (supine blood pressure above 160/90mmhg after taking antihypertensive drugs) 3. Secondary autonomic nervous dysfunction caused by diabetes, spinal cord injury, amyloidosis and uremia 4. Structural heart diseases such as severe arrhythmia, heart valve disease, myocardial infarction, and cardiac insufficiency 5. Heart Implantation Equipment 6. Severe anxiety and depression 7. Severe visual impairment 8. The researcher determines that the subjects have poor compliance or are not suitable to participate in the experiment

Design outcomes

Primary

MeasureTime frame
The experimental group measured upright blood pressure 90 days after startup and evaluated the changes in upright blood pressure compared to baseline;Differences in changes in upright blood pressure compared to baseline between the experimental group and the control group at 90 days after startup;

Secondary

MeasureTime frame
The difference between the upright position blood pressure measured at 90 days after startup in the experimental group and 90 days after enrollment in the control group and the baseline walking distance measured at 90 days after startup in the experimental group and 90 days after enrollment in the control group;Differences in the number of syncope episodes per week between the experimental group and the control group at 90 days after startup compared to baseline;The difference in the number of weekly changes in pre syncope status between the experimental group and the control group at 90 days after startup compared to baseline;Differences in blood pressure variability of blood pressure between the experimental group and the control group at 90 days after startup compared to baseline;Differences in heart rate changes compared to baseline between the experimental group and the control group at 90 days after startup;Differences in changes in the daily living ability assessment scale (ADL) between the experimental group and the control group at 90 days after startup compared to baseline;

Countries

China

Contacts

Public ContactAihua Liu; Xiaohua Zhang

Xuanwu Hospital Capital Medical University

13520637221@163.com+86 135 2063 7221

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026