Status:
TERMINATED
The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy
Lead Sponsor:
Huashan Hospital
Conditions:
Progressive Supranuclear Palsy
Spinal Cord Stimulation
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
The study is an open-label, prospective, single-arm, unicentral (Huashan Hospital Department of Neurology/ Neurosurgery) and exploratory clinical trial. Subjects will be enrolled from Parkinson's dise...
Detailed Description
The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy is an open-label, prospective, single-arm, unicentral and exploratory clinical trial. In the...
Eligibility Criteria
Inclusion
- Clinical diagnosis is Progressive Supranuclear Palsy according to International Movement Disorder society criteria for Progressive Supranuclear Palsy (2017).
- 18FDG-PET imaging was completed within three months before the operation, and the imaging results were consistent with characteristics of Progressive Supranuclear Palsy, supporting the clinical diagnosis of Progressive Supranuclear Palsy.
- 3\. The clinical manifestation is prominent gait balance disorder with "freezing gait", "turn difficulties" and "feet like a stick on the ground", "instabillity" and a fall history in the nearly 6 months (fall number less than or equal to 3 times).Or the researchers observe the existence of gait balance disorder, but patients can still walk without using external things with new freezing gait questionnaire survey more than 1 minute.
- Those who fully understand the research and sign the informed consent.
Exclusion
- Severe mental symptoms or depression state.
- Severe cognitive dysfunction with MMSE less than 20.
- Severe loss of postural reflexes (inability to stand and work independently) and depend on a walker or wheelchair.
- Depend on nasal feeding tube.
- Female in pregnant state when grouped.
- Clear and definite history of neurological diseases (stroke, trauma, tumor, hydrocephalus.
- Complicated with severe heart, liver or renal diseases.
- Clear and definite contraindications for surgery, electrical stimulation and PET examination.
- Unsuitable for surgery according to evaluation before the surgery.
- Other conditions that researchers think unsuitable surgery.
- Those who participant in other clinical trials at the same time.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04367116
Start Date
July 1 2021
End Date
December 27 2023
Last Update
January 2 2024
Active Locations (1)
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1
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040