LONG TERM EFFECTS OF SPINAL CORD STIMULATION (SCS for FOG OL)

February 15, 2024 updated by: Nora Vanegas

LONG TERM EFFECTS OF SPINAL CORD STIMULATION IN PATIENTS WITH PARKINSON'S DISEASE OPEN LABEL EXTENSION TO H-49023

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77005
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: 12-months
Incidence of Adverse Events as assessed by Adverse Event reporting.
12-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New Freezing of Gait Questionnaire (NFOG-Q) score
Time Frame: 12month follow up period
The New Freezing of Gait Questionnaire (NFOG-Q) is a clinician-administered tool that aims to assess both the clinical aspects of FOG as well as its subsequent impairments on quality of life. The task ratings and scales are calculated into a summed NFOG-Q score. The scale is scored from 0-28. A score of 0 means least severe. A score of 28 means the most severe.
12month follow up period
Gait and Falls Questionnaire (GFQ)
Time Frame: 12month follow up period
The Gait and Falls Questionnaire (GFQ) is a clinician-administered tool that aims to assess the specific time when the person experiences freezing of Gait as well as how often they fall. The task ratings and scales are calculated into a summed GFQ score. The scale is scored from 0-64. A score of 0 means least severe. A score of 64 means the most severe.
12month follow up period
MDS-UPDRS score
Time Frame: 12month follow up period
The Movement Disorder Society (MDS) published a revision of the unified Parkinson's disease rating scale, known as the MDS-UPDRS. The Part III: Motor Examination portion of the scale assesses the motor signs of PD and is completed by the examiner. The measure is scored between 0-76 with 0 have the most abnormal motor signs and 76 having normal motor signs.
12month follow up period
Timed Up and Go test (TUG)
Time Frame: 12month follow up period
The Timed Up and Go test measures gait velocity. The Timed Up and Go test is measured in the length of time duration taken to complete. A lower duration means a higher gait speed. A high duration means a lower gain speed.
12month follow up period
Timed 10-meter walk (T10MW)
Time Frame: 12month follow up period
The 10-meter walk measures gait velocity. The 10-meter walk is measured in the length of time duration taken to complete. A lower duration means a higher gait speed. A high duration means a lower gain speed.
12month follow up period
Mini-Mental State Examination (MMSE)
Time Frame: 12month follow up period
This is a test of cognitive function used to screen and track cognitive changes over time. The MMSE is scored between 0 - 30 which 0 meaning there is an abnormal amount of cognitive function and 30 meaning there is a normal amount of cognitive function.
12month follow up period
Montreal Cognitive Assessment Scale (MoCA)
Time Frame: 12month follow up period
This is a test of cognitive function used to screen and track cognitive changes over time. The MoCA is scored between 0 - 30 which 0 meaning there is an abnormal amount of cognitive function and 30 meaning there is a normal amount of cognitive function.
12month follow up period
Beck Depression Inventory (BDI-2)
Time Frame: 12month follow up period
The Beck Depression Inventory (BDI-2) is a 21-item, self-report rating inventory that measures characteristic, attitudes, and symptoms of depression during the past 2 weeks. The score range is 0-63. A total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
12month follow up period
Beck Anxiety Inventory (BAI)
Time Frame: 12month follow up period
The BAI is a 21 self-reported items questionnaire that assess the intensity of physical and cognitive anxiety symptoms during the past week. The score range is 0-63. A total score of 0-7 is considered minimal range, 8-15 is mild, 16-25 is moderate, and 26-63 is severe.
12month follow up period
Parkinson's Disease Questionnaire - 39 (PDQ39)
Time Frame: 12month follow up period
The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life. The measure is scored between 0 - 100 with 0 meaning no health problems and 100 meaning more health problems.
12month follow up period
Non-Motor Symptoms Scale (NMSS)
Time Frame: 12month follow up period
Symptoms assessed over the last month. Each symptom scored with respect to: Severity: 0 = None, 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient. The measure is scored between 0 - 360, with 0 meaning there are no non-motor symptoms and 360 meaning there are non-motor symptoms.
12month follow up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nora Vanegas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Estimated)

February 22, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-54417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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