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
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Recruitment Status
ENROLLING_BY_INVITATION
Total Enrollment
10 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-01-04
Study Completion Date
2025-06-30
Brief Summary
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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. 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. 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.
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. 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. 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.
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Detailed Description
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Freezing of gait (FOG) is a devastating motor phenomenon which may occur in patients with Parkinson's Disease (PD) and other neurodegenerative disorders. It is characterized by episodes during which patients cannot generate effective forward stepping movements in the absence of motor deficits.
FOG leads to reduced mobility, loss of independence, social embarrassment, and caregiver stress. While most motor features of PD respond robustly to dopaminergic agents and deep brain stimulation (DBS), there are currently no effective treatments for FOG.
Indirect evidence from case reports of PD patients undergoing spinal cord stimulation (SCS) for neuropathic pain, has consistently described a positive effect of SCS on FOG. In addition, two recent reports demonstrated that thoracic SCS improved locomotion and FOG in patients with advanced PD. The promising role of SCS for the treatment of FOG in PD has encouraged us to assemble a multi-disciplinary team for the systematic investigation of the motor effects of SCS on FOG, locomotion and other parkinsonian features.
Patients with PD may be able to undergo SCS implantation through experimental protocols such as study H-49023 (NCT03526991) at BCM. We seek to understand the long-term effects of SCS in PD in patients who have participated in H-49023 at BCM.
The current study will use similar assessments as were used in H-49023. Patients will undergo assessments and questionnaires to help identify which setting and parameters produce the best results for the patient. These questionnaires will asses if the patient fell at home and if any non-motor symptoms arise.
FOG leads to reduced mobility, loss of independence, social embarrassment, and caregiver stress. While most motor features of PD respond robustly to dopaminergic agents and deep brain stimulation (DBS), there are currently no effective treatments for FOG.
Indirect evidence from case reports of PD patients undergoing spinal cord stimulation (SCS) for neuropathic pain, has consistently described a positive effect of SCS on FOG. In addition, two recent reports demonstrated that thoracic SCS improved locomotion and FOG in patients with advanced PD. The promising role of SCS for the treatment of FOG in PD has encouraged us to assemble a multi-disciplinary team for the systematic investigation of the motor effects of SCS on FOG, locomotion and other parkinsonian features.
Patients with PD may be able to undergo SCS implantation through experimental protocols such as study H-49023 (NCT03526991) at BCM. We seek to understand the long-term effects of SCS in PD in patients who have participated in H-49023 at BCM.
The current study will use similar assessments as were used in H-49023. Patients will undergo assessments and questionnaires to help identify which setting and parameters produce the best results for the patient. These questionnaires will asses if the patient fell at home and if any non-motor symptoms arise.
Conditions
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Parkinson Disease
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Interventions
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Spinal Cord Stimulator (SCS)
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.
Intervention Type
DEVICE
Other Intervention Names
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Proclaim™ Implantable Pulse Generator with leads
Eligibility Criteria
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Inclusion Criteria
* Ability to sign inform consent
* Underwent SCS implantation as part of participation in H-49023
* Underwent SCS implantation as part of participation in H-49023
Exclusion Criteria
* Severe dementia Inability to participate in motor or cognitive assessments assessments
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Nora Vanegas
OTHER
Sponsor Role
lead
Responsible Party
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Nora Vanegas
Associate Professors of Neurology
Responsibility Role
SPONSOR_INVESTIGATOR
Locations
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Baylor College of Medicine
Houston, Texas, United States
Site Status
Countries
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United States
References
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Other Identifiers
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H-54417
Identifier Type: -
Identifier Source: org_study_id
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