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Spinal Cord sTimulation thEraPy for Parkinson's Disease Patients With Gait Problems (STEP-PD)

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ClinicalTrials.gov Identifier: NCT05110053
Recruitment Status : Recruiting
First Posted : November 5, 2021
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Gait difficulties are common in Parkinson's disease (PD) and cause significant disability. No treatment is available for these symptoms. Spinal Cord Stimulation (SCS) has been found to improve gait, including freezing of gait, in a small number of PD patients. The mechanism of action is unclear and some patients are nonresponders.

With this double-blind placebo-controlled proof of concept and feasibility imaging study, we aim to shed light on the mechanism of action of SCS and collect data to inform development of a scientifically sound clinical trial protocol. We also hope to identify imaging biomarkers at baseline that could be predictive of a favourable or a negative outcome of SCS and improve patient selection. Patients will be assessed with clinical rating scales and gait evaluations at baseline and 6 and 12 months after SCS. They will also receive serial 18F-FDG and ([18F]FEOBV) PET scans to assess the effects of SCS on cortical/subcortical activity and brain cholinergic function


Condition or disease Intervention/treatment Phase
Parkinson Disease Gait Disorders, Neurologic Fall Injury Device: Spinal Cord Stimulator Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded, placebo-controlled intervention study with six month voluntary, active extension.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Following surgery with implantation of Spinal cord stimulator (SCS), participants will be randomized to either active or placebo stimulation. The patient will have no knowledge of group, as the stimulation protocol is designed to be subperceptional. Further, the primary investigators and outcome assessors will be blinded to group assignment. Imaging analysis will likewise be blinded to group assignment.
Primary Purpose: Treatment
Official Title: Spinal Cord sTimulation thEraPy for Parkinson's Disease Patients With Gait Problems
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active
All patients will receive surgery with implantation of a SCS device. Patients randomized to the active arm, will receive active stimulation. However, for the purposes of this study, the stimulation paradigm and intensity is designed to be below perceptional thresholds so as to assure appropriate blinding. Blinding will continue for 6 months, followed by a 6 month voluntary open-phase, active extension.
Device: Spinal Cord Stimulator

Spinal Cord stimulation is a recognized treatment of chronic neuropathic pain. The procedure of implantation is the same in this study. Surgery is done in local anaesthesia. A small electrode is placed in the epidural space corresponding approximately at the Th8-Th10 level.

An impulsegenerator, connected to the electrode, is placed in the subcutaneus fat in the gluteal region.


Placebo Comparator: Placebo
All patients will receive surgery with implantation of a SCS device. Patients randomized to the placebo-arm of the trial will have the device switched of or set to a stimulation intensity of zero. Blinding will continue for 6 months, followed by a 6 month voluntary open-phase, active extension.
Device: Spinal Cord Stimulator

Spinal Cord stimulation is a recognized treatment of chronic neuropathic pain. The procedure of implantation is the same in this study. Surgery is done in local anaesthesia. A small electrode is placed in the epidural space corresponding approximately at the Th8-Th10 level.

An impulsegenerator, connected to the electrode, is placed in the subcutaneus fat in the gluteal region.





Primary Outcome Measures :
  1. Clinical improvement of gait as measured by TUG in s [ Time Frame: Follow-up at 6 and 12 months ]
    Objective changes in gait function as assessed by timed up and go test (TUG), measured in seconds

  2. Clinical improvement of balance as measured by BBS [ Time Frame: Follow-up at 6 and 12 months ]
    Objective changes in gait function as assessed by Berg Balance Scale, scored 0-56, higher scores being better

  3. Clinical improvement of gait [ Time Frame: Follow-up at 6 and 12 months ]
    Objective changes in gait function as assessed by 20 meter walking w obstacles, measured in seconds

  4. Changes in resting metabolic networks assessed with 18-FDG PET/CT [ Time Frame: Follow-up at 6 and 12 months ]

    18-FDG is a tracer characterizing glucose metabolism. Quantification of 18F-FDG PET scans will be performed. Analysis of PET scans will be performed using both a region of interest (ROI) approach sampling hypothesized areas and exploratory Statistical Parametric Mapping (SPM). For each subject, ROIs will be defined on the individual CT and copied onto co-registered PET images. ROIs will include putamen, caudate nuclei, ventral striatum, thalamus, red nucleus, amygdala, hypothalamus, locus coeruleus, median raphe and the ventral tegmental area. SPM will allow automated interrogation of parametric images across the whole brain volume at a voxel level to localize significant differences in tracer uptake without a priori selection of target regions.

    The primary end points are the between-group differences in striatal and extrastriatal tracer uptake/binding.


  5. Changes in brain cholinergic function [ Time Frame: Follow-up at 6 and 12 months ]

    ([18F]FEOBV) PET is an in vivo marker of the brain vesicular acetylcholine transporter (VAChT) and provides information of the integrity of the brain cholinergic neurotransmitter system. Quantification of 18FEOBV scans will be performed. Analysis of PET scans will be performed using both a region of interest (ROI) approach sampling hypothesized areas and exploratory Statistical Parametric Mapping (SPM). For each subject, ROIs will be defined on the individual CT and copied onto co-registered PET images. ROIs will include putamen, caudate nuclei, ventral striatum, thalamus, red nucleus, amygdala, hypothalamus, locus coeruleus, median raphe and the ventral tegmental area. SPM will allow automated interrogation of parametric images across the whole brain volume at a voxel level to localize significant differences in tracer uptake without a priori selection of target regions.

    The primary end points are the between-group differences in striatal and extrastriatal tracer uptake/binding.


  6. Improvement in home based gait ability [ Time Frame: Follow-up at 6 and 12 months ]
    Objective changes in gait function at home using biometric data, collected by the patients themselves using a waist-worn triaxial accelerometer


Secondary Outcome Measures :
  1. subjective changes in quality of life per SF-36 [ Time Frame: Follow-up at 6 and 12 months ]
    Subjective changes in symptom severity and improvements in quality of life as measured by Short Form-36

  2. subjective changes in parkinsons specific quality of life [ Time Frame: Follow-up at 6 and 12 months ]
    Subjective changes in symptom severity and improvements in quality of life as measured by Parkinsons Disease Quality of Life questionnaire (PDQ-39)

  3. subjective changes in gait function [ Time Frame: Follow-up at 6 and 12 months ]
    Subjective changes in symptom severity and improvements in quality of life as measured by Acitivities-specific Balance Confidence scale (ABC)

  4. subjective changes in occurence of freezing [ Time Frame: Follow-up at 6 and 12 months ]
    Subjective changes in symptom severity and improvements in quality of life as measured by the Freezing of Gait Questionnaire (FOGQ)

  5. Overall Changes in PD severity [ Time Frame: Follow-up at 6 and 12 months ]
    Overall changes in symptoms of PD, assessed by the Movement Disorder Society Unified Parkinsons Disease Rating Scale (MDS-UPDRS)

  6. Changes in cognitive function as assessed by moca [ Time Frame: Follow-up at 6 and 12 months ]
    Assessed by MoCA



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Idiopathic PD diagnosed by a movement disorders neurologist
  2. Presence of gait functional impairment despite optimal medical management
  3. Able to walk independently without an aid for a minimum of two minutes without rest
  4. Absence of secondary causes of gait problems
  5. Able to understand study requirements - able to provide consent
  6. Above 50 years of age

Exclusion Criteria:

  1. The presence of another significant neurological/psychiatric disorder or significant disease
  2. Spinal anatomical abnormalities precluding SCS surgery
  3. History of stroke or structural lesions on CT that could interfere with image analysis.
  4. History of chronic pain and severe degenerative spine disease with or without chronic pain
  5. History of drug addiction or dependency
  6. Previous DBS surgery for PD
  7. Pregnancy or breast-feeding.

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): NCT05110053


Contacts
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Contact: Nicola Pavese, MD, PhD, FRCP, FEAN +45 784 61610 npavese@clin.au.dk
Contact: Victor S. Hvingelby, MD +4530220446 au340287@clin.au.dk

Locations
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Denmark
Aarhus University Recruiting
Aarhus, Denmark, 8200
Contact: Helene Nørrelund    +4593508486    hwn@au.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Nicola Pavese, MD, PhD, FRCP, FEAN University of Aarhus
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT05110053    
Other Study ID Numbers: STEP-PD-449
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: As a significant amount of imaging data will be collected over the course of this trial, this data may be made available upon request based upon the relevance and scientific merit of the request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Upon request
Access Criteria: Based on relevant request to a principal investigator

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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.: Yes
Additional relevant MeSH terms:
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Parkinson Disease
Nervous System Diseases
Gait Disorders, Neurologic
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Neurologic Manifestations