Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease. (SCS for FOG)

March 13, 2024 updated by: Nora Vanegas

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 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 evaluate the effectiveness of spinal cord stimulation (SCS) for the management of freezing of gait (FOG) that does not respond to conventional treatments in subjects with Parkinson's disease (PD). The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD.

  1. Assess the safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients.
  2. Explore the effects of two SCS programming paradigms on motor, nonmotor and quality of life measures in PD patients with freezing of gait.

Study Overview

Status

Recruiting

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.

The current study integrates minimally invasive SCS and the use of robotic technology to determine objective gait parameters. The investigators propose a pilot study for the implantation of SCS to the spinal cord on PD patients with treatment-refractory FOG, including a longitudinal assessment of motor outcomes. Motors assessments will include: PAMSys and LEGSys to characterize gait, ActivePERS motion sensor to monitor ambulation parameters and overall activity at home, participants will also be given electronic tablets for the ActivePERS to collect real time information about falls.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Contact:
        • Sub-Investigator:
          • Kimberly Kwei, MD
    • Texas

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males and females between older than 18 years of age.
  • Able to provide informed consent
  • Diagnosed with idiopathic PD (meeting at least two of the three United Kingdom (UK) Brain Bank criteria for PD, specifically bradykinesia plus resting tremor or rigidity) whose major complaints is levodopa refractory FOG. Levodopa refractoriness will be defined as lack of subjective improvement on FOG episodes as reported by the patient.
  • Documented dopaminergic response
  • Optimized PD treatment including dopaminergic medications, and/or deep brain stimulation (DBS) therapy
  • Presence of at least two self-reported levodopa refractory episodes of FOG per day, not limited to start hesitation
  • At least one witnessed freezing event during the screening visit in the 'on' medication state (defined as 45 minutes after a regular dose of Levodopa for the subject being studied)

Exclusion Criteria:

Presence of any co-morbid psychiatric illness(es) that would interfere with the completion of the study or pose risk to the patient, as defined below:

  • Presence of psychosis
  • Depression BDI >14

  • Anxiety BAI >14

    • Presence of an active infection, uncontrolled diabetes mellitus, immunosuppression or other medical contraindications to undergoing SCS implantation
    • Patients who are currently on anticoagulation treatment or unable to hold off the anticoagulants (including Plavix, Aspirin, Warfarin, etc.) 7 days prior to the SCS procedure.
    • Moderate Cognitive Impairment defined by a MoCA < 23
    • Diagnosis of failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) or intractable low back pain and leg pain.
    • Women of childbearing potential will be excluded as from participation due to the limited safety data of thoracic SCS on the fetus.

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

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spinal Cord Stimulation (SCS) Tonic stimulation
Tonic stimulation
Device: Spinal Cord Stimulator (SCS)

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.

Other Names:
  • Proclaim™ Implantable Pulse Generator with leads
Experimental: Spinal Cord Stimulation (SCS) Burst stimulation
Burst stimulation.
Device: Spinal Cord Stimulator (SCS)

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.

Other Names:
  • Proclaim™ Implantable Pulse Generator with leads

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
Change in New Freezing of Gait Questionnaire (NFOG-Q) score
Time Frame: Baseline (pre-surgery), and over a 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.
Baseline (pre-surgery), and over a 12month follow up period
10-meter walk
Time Frame: Baseline (pre-surgery), and over a 12-month 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.
Baseline (pre-surgery), and over a 12-month follow up period
Montreal Cognitive Assessment (MoCA),
Time Frame: Baseline (pre-surgery), and over a 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.
Baseline (pre-surgery), and over a 12month follow up period
Change in MDS-UPDRS score
Time Frame: Baseline (pre-surgery), and over a 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.
Baseline (pre-surgery), and over a 12month follow up period
Non-Motor Symptoms Scale (NMSS)
Time Frame: Baseline (pre-surgery), and over a 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.
Baseline (pre-surgery), and over a 12month follow up period
Parkinson's Disease Questionnaire (PDQ39)
Time Frame: Baseline (pre-surgery), and over a 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.
Baseline (pre-surgery), and over a 12month follow up period

Collaborators and Investigators

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

Sponsor

Nora Vanegas

Investigators

  • Principal Investigator: Nora Vanegas, MD, Baylor College of Medicine

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)

August 1, 2021

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 16, 2018

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-49023

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

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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