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

NCT04683861 | Unknown

• 1 other identifier: 20201203
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 and Parkinsonism-Plus syndrome.

Conditions

Freezing of Gait

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  twelve months after surgery.

Secondary Outcomes (3)

• change in PD-related quality of life(PDQ-39)

  twelve months after surgery.

• change in motor examination( Movement Disorders Society's revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III)

  twelve months after surgery.

• Clinical Global Impression-Global Improvement (CGI-GI)

  twelve months after surgery.

Study Arms (1)

Spinal cord stimulation therapy

EXPERIMENTAL

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

Procedure: Spinal cord stimulation

Interventions

Spinal cord stimulation 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.

Spinal cord stimulation therapy

Eligibility Criteria

• Age: 40 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• zhangyuqing: lead

Study Sites (1)

Capital Medical University of Xuanwu Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Yuqung Zhang, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiping Li, MD

CONTACT

8610-83198899-8630; yhljp89@163.com

Shanshan Mei, MD

CONTACT

sophy33@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 24, 2020
• Study Start: December 8, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)