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

Primary Purpose

Parkinson Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Spinal Cord Stimulator (SCS)

About this trial

This is an interventional device feasibility trial for Parkinson Disease focused on measuring Freezing of Gait, Locomotion, Spinal cord stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Columbia UniversityRecruiting
Baylor College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Spinal Cord Stimulation (SCS) Tonic stimulation

Spinal Cord Stimulation (SCS) Burst stimulation

Arm Description

Tonic stimulation

Burst stimulation.

Outcomes

Primary Outcome Measures

Safety and Tolerability

Incidence of Adverse Events as assessed by Adverse Event reporting.

Secondary Outcome Measures

Change in New Freezing of Gait Questionnaire (NFOG-Q) score

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.

10-meter walk

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.

Montreal Cognitive Assessment (MoCA),

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.

Change in MDS-UPDRS score

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.

Non-Motor Symptoms Scale (NMSS)

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.

Parkinson's Disease Questionnaire (PDQ39)

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.

Full Information

NCT ID

NCT03526991

First Posted

May 4, 2018

Last Updated

May 8, 2023

Sponsor

Nora Vanegas

1. Study Identification

Unique Protocol Identification Number

NCT03526991

Brief Title

Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease.

Acronym

SCS for FOG

Official Title

Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nora Vanegas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Freezing of Gait, Locomotion, Spinal cord stimulation

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

A total of 10 patients with a diagnosis of Parkinson's disease and treatment refractory freezing of gait will be recruited in this study.

Masking

Participant

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Spinal Cord Stimulation (SCS) Tonic stimulation

Arm Type

Experimental

Arm Description

Tonic stimulation

Arm Title

Spinal Cord Stimulation (SCS) Burst stimulation

Arm Type

Experimental

Arm Description

Burst stimulation.

Intervention Type

Device

Intervention Name(s)

Spinal Cord Stimulator (SCS)

Other Intervention Name(s)

Proclaim™ Implantable Pulse Generator with leads

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety and Tolerability

Description

Incidence of Adverse Events as assessed by Adverse Event reporting.

Time Frame

12-months

Secondary Outcome Measure Information:

Title

Change in New Freezing of Gait Questionnaire (NFOG-Q) score

Description

Time Frame

Baseline (pre-surgery), and over a 12month follow up period

Title

10-meter walk

Description

Time Frame

Baseline (pre-surgery), and over a 12-month follow up period

Title

Montreal Cognitive Assessment (MoCA),

Description

Time Frame

Baseline (pre-surgery), and over a 12month follow up period

Title

Change in MDS-UPDRS score

Description

Time Frame

Baseline (pre-surgery), and over a 12month follow up period

Title

Non-Motor Symptoms Scale (NMSS)

Description

Time Frame

Baseline (pre-surgery), and over a 12month follow up period

Title

Parkinson's Disease Questionnaire (PDQ39)

Description

Time Frame

Baseline (pre-surgery), and over a 12month follow up period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nora Vanegas, MD

Phone

713-798-2273

Nora.VanegasArroyave@bcm.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Rory Mahabir

Phone

713-798-5989

rory.mahabir@bcm.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nora Vanegas, MD

Organizational Affiliation

Baylor College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Natasha D Desai

nd2528@cumc.columbia.edu

First Name & Middle Initial & Last Name & Degree

Kimberly Kwei, MD

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77005

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nora Vanegas

u235844@bcm.edu

First Name & Middle Initial & Last Name & Degree

Rory Mahabir

rory.mahabir@bcm.edu

12. IPD Sharing Statement

Plan to Share IPD

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Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease.

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