Back to results

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

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:

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.

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

NCT ID

NCT04367116

First Posted

April 27, 2020

Last Updated

March 24, 2022

Sponsor

Huashan Hospital

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

Studies a U.S. FDA-regulated Device Product

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

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

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

jungliw@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Feng-Tao Liu, MD

Phone

86-21-52888163

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

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

We'll reach out to this number within 24 hrs