The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy

Progressive Supranuclear Palsy Clinical Trial

Official title:

The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04367116
• Other study ID #: KY2019-506
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 27, 2023

Study information

• Verified date: December 2023
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 27, 2023
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Progressive Supranuclear Palsy
• Spinal Cord Stimulation
• Supranuclear Palsy, Progressive

Intervention

Procedure:
• Spinal Cord Stimulation
Spinal cord stimulation is a treatment that implants a electrode in posterior epidural space of patient's spinal canal to send mild electric current to stimulate conducting bundle of the posterior column of the spinal cord and posterior horn sensory neurons.

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Spinal Cord Stimulation	Safety evaluation will be performed 3 months after Spinal Cord Stimualtion	3 months
Primary	Efficacy of Spinal Cord Stimulation on walk gait.	The change of 10 Meter Walk Test (10MWT) scores. The 10MWT recorded the time to finish the test, and the maximum time is 5 minutes. The longer time suggest more severe condition.	3 months after Spinal Cord Stimualtion.
Primary	Efficacy of Spinal Cord Stimulation on walk time.	Changes of the Time Up & Go (TUG) test score. TUG test recorded the time to finish the test, the minimum time is 0 and the maximum time is 5 minutes. The longer time suggest more severe condition.	3 months after Spinal Cord Stimualtion.
Secondary	Alteration of cerebral metabolism in 18F-FDG-PET imaging	Alteration of cerebral metabolism in 18F-FDG-PET imaging 6 months after Spinal Cord Stimualtion	6 months
Secondary	Alteration of gait, balance and motor score	Alteration of gait, balance and motor score 1 month, 6 months after Spinal Cord Stimualtion. The New Freezing of Gait Questionnaire (NFOG-Q) will be assessed, with the minimum score to be 0 and the maximum score to be 30 scores, with higher scores suggest more severe condition.	1 month, 6 months