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

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ClinicalTrials.gov Identifier: NCT03526991
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Nora Vanegas, Baylor College of Medicine

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.

  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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Spinal Cord Stimulator (SCS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Single (Participant)
Primary Purpose: Device Feasibility
Official Title: Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease.
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Proclaim™ Implantable Pulse Generator with leads




Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 12-months ]
    Incidence of Adverse Events as assessed by Adverse Event reporting.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526991


Contacts
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Contact: Nora Vanegas, MD 713-798-2273 Nora.VanegasArroyave@bcm.edu
Contact: Rory Mahabir 713-798-5989 rory.mahabir@bcm.edu

Locations
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United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Natasha D Desai       nd2528@cumc.columbia.edu   
Sub-Investigator: Kimberly Kwei, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77005
Contact: Nora Vanegas       u235844@bcm.edu   
Contact: Rory Mahabir       rory.mahabir@bcm.edu   
Sponsors and Collaborators
Nora Vanegas
Investigators
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Principal Investigator: Nora Vanegas, MD Baylor College of Medicine
Publications:
Giladi N, Kao R, Fahn S. Freezing Phenomenon , the Fifth Cardinal Sign of Parkinsonism Freezing Phenomenon in Patients with Parkinsonian Syndromes. 2016;(January). doi:10.1007/978-1-4615-5337-3.
Soltani F, Lalkhen A. Improvement of Parkinsonian Symptoms With Spinal Cord Stimulation: Consequence or Coincidence? J Neurol Neurosurg Psychiatry. 2013;84(11):e2.74-e2. doi:10.1136/jnnp-2013-306573.165.
Isao TA and. The 70th Annual Meeting Special Topics - Part I : Validation and Prospects for Neuromodulation Spinal Cord Stimulation for the Treatment of Abnormal Posture and Gait Disorder in Patients With Parkinson â€TM s Disease. Neurol Med
Weise D, Winkler D, Meixensberger J, Classen J. Effects of spinal cord stimulation in a patient with Parkinson's disease and chronic back pain. J Neurol. 2010;257:S217.

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Responsible Party: Nora Vanegas, Assistant Professor of Neurology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03526991    
Other Study ID Numbers: H-49023
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Nora Vanegas, Baylor College of Medicine:
Freezing of Gait
Locomotion
Spinal cord stimulation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases