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

NCT04367116 | Terminated DMC

• 1 other identifier: KY2019-506
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Progressive Supranuclear Palsy; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Alteration of cerebral metabolism in 18F-FDG-PET imaging

  6 months

• Alteration of gait, balance and motor score

  1 month, 6 months

Study Arms (1)

spinal cord stimulation

EXPERIMENTAL

the spinal cord stimulation was performed and operated

Procedure: Spinal Cord Stimulation

Interventions

Spinal Cord Stimulation PROCEDURE

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.

spinal cord stimulation

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis is Progressive Supranuclear Palsy according to International Movement Disorder society criteria for Progressive Supranuclear Palsy (2017).
• FDG-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.
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Feng-Tao Liu, MD

  Huashan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of neurology

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: July 1, 2021
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

CN (1)