MedDataX Logo

Spinal Cord Stimulation Therapy for Freezing of Gait in Parkinson's Syndrome Patients

NCT ID: NCT04683861

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-08

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Freezing of Gait

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

spinal cord stimulation freezing of gait Parkinson's disease Parkinsonism-Plus syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Spinal cord stimulation therapy

Spinal cord stimulation at the thoracic levels ranging from T10 to T12.

Group Type EXPERIMENTAL

Spinal cord stimulation

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spinal cord stimulation

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. aged between 40 and 76 years
2. patients with advanced Parkinson's disease, or multiple system atrophy with predominant parkinsonism or progressive supranuclear palsy (PSP)
3. 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.
4. 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.

Exclusion Criteria

1. 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
2. surgical or medical contraindications to spinal cord stimulation surgery(e.g. uncontrolled hypertension, advanced coronary artery disease).
Minimum Eligible Age

40 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

zhangyuqing

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

zhangyuqing

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yuqung Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Capital Medical University of Xuanwu Hospital

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jiping Li, MD

Role: CONTACT

Phone: 8610-83198899-8630

Email: [email protected]

Shanshan Mei, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jiping Li, MD

Role: primary

Shanshan Mei, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20201203

Identifier Type: -

Identifier Source: org_study_id