LONG TERM EFFECTS OF SPINAL CORD STIMULATION

NCT06272955 | Enrolling By Invitation FDA Device

• 1 other identifier: H-54417
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not always improve FOG. Since many traditional therapies have failed for the treatment of FOG, researchers have proposed the use of newer treatments. Recent research in animal models and clinical human data using Spinal Cord Stimulation (SCS) has produced promising results, specifically showing improvement in FOG with the use of SCS in patients with PD. The purpose of this study is to explore the long-term motor and non-motor effects of SCS in PD patients after completing participation on H-49023. The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD.

1. 1.Assess the long-term safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients.
2. 2.Allowing patients to choose between the two SCS programming paradigms based on their motor, nonmotor and quality of life measures in PD patients with freezing of gait.

Conditions

Parkinson Disease

Keywords

Spinal cord stimulation; Locomotion; Freezing of Gait

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Incidence of Adverse Events as assessed by Adverse Event reporting.

  12-months

Secondary Outcomes (11)

• New Freezing of Gait Questionnaire (NFOG-Q) score

  12month follow up period

• Gait and Falls Questionnaire (GFQ)

  12month follow up period

• MDS-UPDRS score

  12month follow up period

• Timed Up and Go test (TUG)

  12month follow up period

• Timed 10-meter walk (T10MW)

  12month follow up period

Interventions

Spinal Cord Stimulator (SCS) DEVICE

Patients are already implanted with device from the H-49023 study. The SCS implantation technique consists of inserting epidural leads-containing multiple stimulating electrodes (8). Two leads will be implanted percutaneously into the epidural space. The implantable pulse generator (IPG) is a neurostimulation system designed to deliver low-intensity electrical impulses. The system is intended to be used with leads and extensions that are compatible with the system. This neurostimulation system is indicated (FDA approved) as an aid in the management of chronic, intractable pain of the trunk and/or limbs. The intended use in this study is considered experimental.

Also known as: Proclaim™ Implantable Pulse Generator with leads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were enrolled in H-49023 Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease, will be given the option to enroll in this study.

You may qualify if:

• Ability to sign inform consent
• Underwent SCS implantation as part of participation in H-49023

You may not qualify if:

• Severe dementia Inability to participate in motor or cognitive assessments assessments

Sponsors & Collaborators

• Nora Vanegas: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77005, United States

Location

Related Publications (41)

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MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professors of Neurology

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: January 4, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)