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

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.

Study Overview

• Status: Terminated
• Conditions: Progressive Supranuclear Palsy; Spinal Cord Stimulation
• Intervention / Treatment: Procedure: Spinal Cord Stimulation

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
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian-Jun Wu, MD; Phone Number: 86-21-52888163; Email: jungliw@gmail.com
• Study Contact Backup: Name: Feng-Tao Liu, MD; Phone Number: 86-21-52888163; Email: liufengtao@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: spinal cord stimulation; the spinal cord stimulation was performed and operated	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Spinal Cord Stimulation	Safety evaluation will be performed 3 months after Spinal Cord Stimualtion	3 months
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Investigators: Study Director: Feng-Tao Liu, MD, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): December 27, 2023
• Study Completion (Actual): December 27, 2023

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Tauopathies; Cranial Nerve Diseases; Ocular Motility Disorders; Paralysis; Ophthalmoplegia; Supranuclear Palsy, Progressive
• Other Study ID Numbers: KY2019-506

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No