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

Primary Purpose

Progressive Supranuclear Palsy, Spinal Cord Stimulation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Spinal Cord Stimulation
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Supranuclear Palsy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Huashan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

spinal cord stimulation

Arm Description

the spinal cord stimulation was performed and operated

Outcomes

Primary Outcome Measures

Safety of Spinal Cord Stimulation
Safety evaluation will be performed 3 months after Spinal Cord Stimualtion
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.
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.

Secondary Outcome Measures

Alteration of cerebral metabolism in 18F-FDG-PET imaging
Alteration of cerebral metabolism in 18F-FDG-PET imaging 6 months after Spinal Cord Stimualtion
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.

Full Information

First Posted
April 27, 2020
Last Updated
March 24, 2022
Sponsor
Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04367116
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Supranuclear Palsy, Spinal Cord Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The assessors were blind to the stimulation status of the patient.
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
spinal cord stimulation
Arm Type
Experimental
Arm Description
the spinal cord stimulation was performed and operated
Intervention Type
Procedure
Intervention Name(s)
Spinal Cord Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of Spinal Cord Stimulation
Description
Safety evaluation will be performed 3 months after Spinal Cord Stimualtion
Time Frame
3 months
Title
Efficacy of Spinal Cord Stimulation on walk gait.
Description
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.
Time Frame
3 months after Spinal Cord Stimualtion.
Title
Efficacy of Spinal Cord Stimulation on walk time.
Description
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.
Time Frame
3 months after Spinal Cord Stimualtion.
Secondary Outcome Measure Information:
Title
Alteration of cerebral metabolism in 18F-FDG-PET imaging
Description
Alteration of cerebral metabolism in 18F-FDG-PET imaging 6 months after Spinal Cord Stimualtion
Time Frame
6 months
Title
Alteration of gait, balance and motor score
Description
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.
Time Frame
1 month, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian-Jun Wu, MD
Phone
86-21-52888163
Email
jungliw@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Feng-Tao Liu, MD
Phone
86-21-52888163
Email
liufengtao@fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng-Tao Liu, MD
Organizational Affiliation
Huashan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Wang
Phone
86-2152888160
Email
wangjian336@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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