Freezing of GaitNCT04683861
Spinal Cord Stimulation Therapy for Freezing of Gait in Parkinson's Syndrome Patients
A study testing Spinal cord stimulation in people with Freezing of Gait, run by zhangyuqing at 1 site in China.
Trial summary
Spinal cord stimulation may be a new therapeutic approach for freezing of gait. It's a multi-center, prospective, open label clinical study with a 12 months follow-up period, to investigate the therapeutic effect and safety of spinal cord stimulation for freezing of gait in patients with advanced Parkinson's disease… Read more about this study
- Who is it for?
- Ages 40 to 76 years
- Conditions the study is for
- Freezing of Gait
- 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
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2020to 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 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 40 and 76 years
- patients with advanced Parkinson's disease, or multiple system atrophy with predominant parkinsonism or progressive supranuclear palsy (PSP)
- with significant freezing of gait ( Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale III item 11≥2), and the gait dysfunction treatable by medication but not adequately controlled with medications.
- Understand potential risk/benefit, consent to the study, study procedures, and agree to complete the study follow-up visits and comply with the study protocol requirements.
Who cannot join
- cognitive impairment ( MMSE≤24), depression (HAMD>24),acute psychosis, active alcohol or drug abuse, terminal illness, and any major medical or psychological histories, diagnoses, conditions, or comorbidities that would interfere with participation in the study per the investigatior's medical judgment
- surgical or medical contraindications to spinal cord stimulation surgery(e.g. uncontrolled hypertension, advanced coronary artery disease).
Trial locations and contacts
1 site in 1 country.
Shanshan Mei, MD contact
China1 site, 1 recruiting
- Recruiting
Capital Medical University of Xuanwu Hospital
Beijing
Jiping Li, MD, 8610-83198899-8630, yhljp89@163.com
Shanshan Mei, MD, 8610-83198899-2282, sophy33@163.com
About this study
Official title: Spinal Cord Stimulation Therapy for Freezing of Gait in Patients With Advanced Parkinson's Disease and Parkinsonism-Plus Syndrome
Spinal cord stimulation may be a new therapeutic approach for freezing of gait. It's a multi-center, prospective, open label clinical study with a 12 months follow-up period, to investigate the therapeutic effect and safety of spinal cord stimulation for freezing of gait in patients with advanced Parkinson's disease and Parkinsonism-Plus syndrome.
Read the detailed description
Benefits of dopaminergic therapy and deep brain stimulation are limited for freezing of gait in Parkinson's syndrome. Spinal cord stimulation is a well-established therapy for the treatment of chronic neuropathic pain. Recently, some pilot studies demonstrated the safety and significant therapeutic effect of Spinal cord stimulation in freezing of gait patients suffering from various movement disorders, such as Parkinson's disease, primary progressive freezing of gait, and multiple system atrophy with predominant Parkinsonism. Spinal cord stimulation may be a new therapeutic approach for freezing of gait. However, evidence from larger numbers of subjects is still lacking, especially little is known about its efficacy for gait and posture dysfunction in Parkinsonism-Plus syndrome patients. The objective of this study is to investigate the therapeutic effect and safety of spinal cord stimulation for freezing of gait in patients with advanced Parkinson's disease and Parkinsonism-Plus syndrome.
It's a multi-center, prospective, open label clinical study with a 12 months follow-up period. The intended study population is individuals suffering from advanced Parkinson's disease, multiple system atrophy with predominant parkinsonism or progressive supranuclear palsy. Each participant will complete an enrollment/screening/baseline visit, a spinal cord stimulation implant and activation visit, and a minimum of two follow-up visits, including visit at 3 months and the final study visit at 12months. The participants will proceed to implantation after satisfying implant inclusion and exclusion criteria. Paddle-shaped Spinal cord stimulation electrode with 16 contacts (AdaptiveStim® 39, 565; Medtronic, Minneapolis, USA) will be implanted into the epidural space at the thoracic levels ranging from T10 to T12. Electrode position will be verified by X-ray. The stimulators will be turned on within 1 month after electrode implantation surgery. The stimulation parameters could vary freely, but medications will be kept constant during the study period. At the end of month 12, participants will enter the long-term follow-up in which medications and stimulation parameters could vary freely.
- Conditions
- Freezing of Gait
- Being tested
- Spinal cord stimulation
- Keywords
- spinal cord stimulation, freezing of gait, Parkinson's disease, Parkinsonism-Plus syndrome
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulationProcedure or surgery
Paddle-shaped Spinal cord stimulation electrode with 16 contacts (AdaptiveStim® 39, 565; Medtronic, USA) will be implanted into the epidural space at the thoracic levels ranging from T10 to T12.
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord stimulation therapy | Experimental | Spinal cord stimulation at the thoracic levels ranging from T10 to T12. Receives: Procedure: Spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in severity of freezing of gait
demonstrate statistically significant improvement in score of "New Freezing of Gait Questionnaire (NFOGQ)" from baseline to 12 months
Measured: twelve months after surgery
change in the score of "Gait and Fall Questionnaire (GFQ)"
demonstrate statistically significant improvement in score of GFQ from baseline to 12 months
Measured: twelve months after surgery.
Secondary outcomes (3)
change in PD-related quality of life(PDQ-39)
demonstrate statistically significant improvement in PD-related quality of life(PDQ-39) from baseline to 12 months
Measured: twelve months after surgery.
change in motor examination( Movement Disorders Society's revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III)
demonstrate the change in motor score (MDS-UPDRS III) from baseline( Off medication) to 12 months (On stimulation/Off medication)
Measured: twelve months after surgery.
Clinical Global Impression-Global Improvement (CGI-GI)
to evaluate effectiveness on the basis of the physician's assessment, as well as on the basis of the patients'self-reported satisfaction. It is rated on a 7-point scale, range from 1(very much improved) through to 7 (very much worse)
Measured: twelve months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start8 Dec 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Freezing of GaitStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- zhangyuqing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, zhangyuqing, Xuanwu Hospital, Beijing
- Investigators
- Yuqung Zhang, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683861
- Sponsor's protocol ID
- 20201203
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation Therapy for Freezing of Gait in Patients With Advanced Parkinson's Disease and Parkinsonism-Plus Syndrome
- ClinicalTrials.gov ID
- NCT04683861
- Acronym / sponsor ID
- 20201203
- Conditions
- Freezing of Gait
- Keywords
- spinal cord stimulation, freezing of gait, Parkinson's disease, Parkinsonism-Plus syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- zhangyuqingUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Dec 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.
Spinal cord stimulation may be a new therapeutic approach for freezing of gait. It's a multi-center, prospective, open label clinical study with a 12 months follow-up period, to investigate the therapeutic effect and safety of spinal cord stimulation for freezing of gait in patients with advanced Parkinson's disease and Parkinsonism-Plus syndrome.
Detailed description
Benefits of dopaminergic therapy and deep brain stimulation are limited for freezing of gait in Parkinson's syndrome. Spinal cord stimulation is a well-established therapy for the treatment of chronic neuropathic pain. Recently, some pilot studies demonstrated the safety and significant therapeutic effect of Spinal cord stimulation in freezing of gait patients suffering from various movement disorders, such as Parkinson's disease, primary progressive freezing of gait, and multiple system atrophy with predominant Parkinsonism. Spinal cord stimulation may be a new therapeutic approach for freezing of gait. However, evidence from larger numbers of subjects is still lacking, especially little is known about its efficacy for gait and posture dysfunction in Parkinsonism-Plus syndrome patients. The objective of this study is to investigate the therapeutic effect and safety of spinal cord stimulation for freezing of gait in patients with advanced Parkinson's disease and Parkinsonism-Plus syndrome.
It's a multi-center, prospective, open label clinical study with a 12 months follow-up period. The intended study population is individuals suffering from advanced Parkinson's disease, multiple system atrophy with predominant parkinsonism or progressive supranuclear palsy. Each participant will complete an enrollment/screening/baseline visit, a spinal cord stimulation implant and activation visit, and a minimum of two follow-up visits, including visit at 3 months and the final study visit at 12months. The participants will proceed to implantation after satisfying implant inclusion and exclusion criteria. Paddle-shaped Spinal cord stimulation electrode with 16 contacts (AdaptiveStim® 39, 565; Medtronic, Minneapolis, USA) will be implanted into the epidural space at the thoracic levels ranging from T10 to T12. Electrode position will be verified by X-ray. The stimulators will be turned on within 1 month after electrode implantation surgery. The stimulation parameters could vary freely, but medications will be kept constant during the study period. At the end of month 12, participants will enter the long-term follow-up in which medications and stimulation parameters could vary freely.
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 therapy | Experimental | Procedure: Spinal cord stimulationSpinal cord stimulation at the thoracic levels ranging from T10 to T12. |
Who may qualify
- Ages
- 40 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged between 40 and 76 years
- patients with advanced Parkinson's disease, or multiple system atrophy with predominant parkinsonism or progressive supranuclear palsy (PSP)
- with significant freezing of gait ( Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale III item 11≥2), and the gait dysfunction treatable by medication but not adequately controlled with medications.
- Understand potential risk/benefit, consent to the study, study procedures, and agree to complete the study follow-up visits and comply with the study protocol requirements.
Key exclusion criteria (2 listed)
- cognitive impairment ( MMSE≤24), depression (HAMD>24),acute psychosis, active alcohol or drug abuse, terminal illness, and any major medical or psychological histories, diagnoses, conditions, or comorbidities that would interfere with participation in the study per the investigatior's medical judgment
- surgical or medical contraindications to spinal cord stimulation surgery(e.g. uncontrolled hypertension, advanced coronary artery disease).
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 stimulationPaddle-shaped Spinal cord stimulation electrode with 16 contacts (AdaptiveStim® 39, 565; Medtronic, USA) will be implanted into the epidural space at the thoracic levels ranging from T10 to T12. | Procedure or surgery | Spinal cord stimulation therapy |
Primary outcome
change in severity of freezing of gait
Time frame: twelve months after surgery
demonstrate statistically significant improvement in score of "New Freezing of Gait Questionnaire (NFOGQ)" from baseline to 12 months
change in the score of "Gait and Fall Questionnaire (GFQ)"
Time frame: twelve months after surgery.
demonstrate statistically significant improvement in score of GFQ from baseline to 12 months
3 secondary outcomes
change in PD-related quality of life(PDQ-39)
Time frame: twelve months after surgery.
change in motor examination( Movement Disorders Society's revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III)
Time frame: twelve months after surgery.
Clinical Global Impression-Global Improvement (CGI-GI)
Time frame: twelve months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Freezing of Gait
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Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
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Function-based Accelerated Stimulation Therapy (FAST-therapy) for Freezing of Gait (FOG) After Parkinson's Disease (PD)
Parkinson Disease
Active, not recruitingPhase 2
Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
Freezing of Gait, Parkinson Disease
RecruitingObservational study
Visuomotor Control in Parkinson Disease
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Recruiting
Correlation of STN-DBS Induced Visuospatial Changes and Freezing of Gait
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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.
Shanshan Mei, MD contact
Yuqung Zhang, MD principal investigator
Xuanwu Hospital, Beijing
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 Freezing of Gait, run by zhangyuqing 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 2 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: status not confirmed, as of the sponsor's last update on 24 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiping Li, MD (8610-83198899-8630, yhljp89@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in severity of freezing of gait (time frame: twelve months after surgery). The study lists 2 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 24 Dec 2020.