Clinical trial NCT04367116: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Progressive Supranuclear Palsy
Spinal Cord Stimulation
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 3
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety of Spinal Cord Stimulation
timeFrame: 3 months
measure: Efficacy of Spinal Cord Stimulation on walk gait.
timeFrame: 3 months after Spinal Cord Stimualtion.
measure: Efficacy of Spinal Cord Stimulation on walk time.
timeFrame: 3 months after Spinal Cord Stimualtion.
Secondary outcomes:
measure: Alteration of cerebral metabolism in 18F-FDG-PET imaging
timeFrame: 6 months
measure: Alteration of gait, balance and motor score
timeFrame: 1 month, 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Feng-Tao Liu, MD
role: STUDY_DIRECTOR
References: