Progressive Supranuclear PalsyNCT04367116
The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy
A study testing Spinal Cord Stimulation in people with Progressive Supranuclear Palsy and Spinal Cord Stimulation, run by Huashan Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Progressive Supranuclear Palsy, Spinal Cord Stimulation
- What is being tested?
- Spinal Cord Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 27 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Spinal Cord Stimulation
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| spinal cord stimulation | Experimental | the spinal cord stimulation was performed and operated Receives: Procedure: Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Spinal Cord Stimulation
Safety evaluation will be performed 3 months after Spinal Cord Stimualtion
Measured: 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.
Measured: 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.
Measured: 3 months after Spinal Cord Stimualtion.
Secondary outcomes (2)
Alteration of cerebral metabolism in 18F-FDG-PET imaging
Alteration of cerebral metabolism in 18F-FDG-PET imaging 6 months after Spinal Cord Stimualtion
Measured: 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.
Measured: 1 month, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Jul 2021
- Primary completion27 Dec 2023
- Study completion27 Dec 2023
Why it stopped: Our study hasn't been funded so far, but we will continue this study in the future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Wang, Huashan Hospital
- Investigators
- Feng-Tao Liu, MD, Study director, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367116
- Sponsor's protocol ID
- KY2019-506
- Status last verified
- Dec 2023
- First submitted
- 27 Apr 2020
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy
- ClinicalTrials.gov ID
- NCT04367116
- Acronym / sponsor ID
- KY2019-506
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Our study hasn't been funded so far, but we will continue this study in the future.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spinal cord stimulation | Experimental | Procedure: Spinal Cord Stimulationthe spinal cord stimulation was performed and operated |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord StimulationSpinal 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. | Procedure or surgery | spinal cord stimulation |
Primary outcome
Safety of Spinal Cord Stimulation
Time frame: 3 months
Safety evaluation will be performed 3 months after Spinal Cord Stimualtion
Efficacy of Spinal Cord Stimulation on walk gait.
Time frame: 3 months after Spinal Cord Stimualtion.
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.
Time frame: 3 months after Spinal Cord Stimualtion.
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.
2 secondary outcomes
Alteration of cerebral metabolism in 18F-FDG-PET imaging
Time frame: 6 months
Alteration of gait, balance and motor score
Time frame: 1 month, 6 months
Results and safety
The study was stopped early (reason given: Our study hasn't been funded so far, but we will continue this study in the future.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng-Tao Liu, MD study director
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation in people with Progressive Supranuclear Palsy and Spinal Cord Stimulation, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Our study hasn't been funded so far, but we will continue this study in the future.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Spinal Cord Stimulation (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.