Brief Title
The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy
Official Title
The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy
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 disease and Movement Disorder specialized outpatient department of Neurology in
Huashan Hospital and network platform of chronic diseases. Spinal Cord Stimultion (SCS) will
be performed in department of Neurosurgery and cerebral metabolism will be assessed in PET
center of Huashan Hospital. Specialists in Neurology will follow up 3 months to record any
unsafe incidents of progressive supranuclear palsy patients after the SCS surgery to evaluate
safety. Meanwhile, improvement in gait disorder (including 10MWT and TUG test score) will be
measured to evaluate efficacy.
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 screening stage, patients clinically and radiologically diagnosed as progressive
supranuclear palsy with prominent gait disturbance will be enrolled. Then comprehensive
evaluations and spinal cord stimulation will be performed on patients eligible for
stimulation. In the subsequent process of neuromodulation, changes of clinical presentations
and cerebral metabolism of participants will be assessed. Any unsafe incidents in process
will be recorded in detail.
Study Type
Interventional
Primary Outcome
Safety of Spinal Cord Stimulation
Secondary Outcome
Alteration of cerebral metabolism in 18F-FDG-PET imaging
Condition
Progressive Supranuclear Palsy
Intervention
Spinal Cord Stimulation
Study Arms / Comparison Groups
spinal cord stimulation
Description: the spinal cord stimulation was performed and operated
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
10
Start Date
July 1, 2021
Completion Date
December 31, 2023
Primary Completion Date
December 31, 2023
Eligibility Criteria
Inclusion Criteria:
1. Clinical diagnosis is Progressive Supranuclear Palsy according to International
Movement Disorder society criteria for Progressive Supranuclear Palsy (2017).
2.18FDG-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.
4.Those who fully understand the research and sign the informed consent.
Exclusion Criteria:
1. Severe mental symptoms or depression state.
2. Severe cognitive dysfunction with MMSE less than 20.
3. Severe loss of postural reflexes (inability to stand and work independently) and
depend on a walker or wheelchair.
4. Depend on nasal feeding tube.
5. Female in pregnant state when grouped.
6. Clear and definite history of neurological diseases (stroke, trauma, tumor,
hydrocephalus.
7. Complicated with severe heart, liver or renal diseases.
8. Clear and definite contraindications for surgery, electrical stimulation and PET
examination.
9. Unsuitable for surgery according to evaluation before the surgery.
10. Other conditions that researchers think unsuitable surgery.
11. Those who participant in other clinical trials at the same time.
Gender
All
Ages
40 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Feng-Tao Liu, MD, 86-21-52888163, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04367116
Organization ID
KY2019-506
Responsible Party
Principal Investigator
Study Sponsor
Huashan Hospital
Study Sponsor
Feng-Tao Liu, MD, Study Director, Huashan Hospital
Verification Date
March 2022