Parkinson Disease Clinical Trial
— STEP-PDOfficial title:
Spinal Cord sTimulation thEraPy for Parkinson's Disease Patients With Gait Problems
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
Status | Recruiting |
Enrollment | 12 |
Est. completion date | February 1, 2024 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical improvement of gait as measured by TUG in s | Objective changes in gait function as assessed by timed up and go test (TUG), measured in seconds | Follow-up at 6 and 12 months | |
Primary | Clinical improvement of balance as measured by BBS | Objective changes in gait function as assessed by Berg Balance Scale, scored 0-56, higher scores being better | Follow-up at 6 and 12 months | |
Primary | Clinical improvement of gait | Objective changes in gait function as assessed by 20 meter walking w obstacles, measured in seconds | Follow-up at 6 and 12 months | |
Primary | Changes in resting metabolic networks assessed with 18-FDG PET/CT | 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. |
Follow-up at 6 and 12 months | |
Primary | Changes in brain cholinergic function | ([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. |
Follow-up at 6 and 12 months | |
Primary | Improvement in home based gait ability | Objective changes in gait function at home using biometric data, collected by the patients themselves using a waist-worn triaxial accelerometer | Follow-up at 6 and 12 months | |
Secondary | subjective changes in quality of life per SF-36 | Subjective changes in symptom severity and improvements in quality of life as measured by Short Form-36 | Follow-up at 6 and 12 months | |
Secondary | subjective changes in parkinsons specific quality of life | Subjective changes in symptom severity and improvements in quality of life as measured by Parkinsons Disease Quality of Life questionnaire (PDQ-39) | Follow-up at 6 and 12 months | |
Secondary | subjective changes in gait function | Subjective changes in symptom severity and improvements in quality of life as measured by Acitivities-specific Balance Confidence scale (ABC) | Follow-up at 6 and 12 months | |
Secondary | subjective changes in occurence of freezing | Subjective changes in symptom severity and improvements in quality of life as measured by the Freezing of Gait Questionnaire (FOGQ) | Follow-up at 6 and 12 months | |
Secondary | Overall Changes in PD severity | Overall changes in symptoms of PD, assessed by the Movement Disorder Society Unified Parkinsons Disease Rating Scale (MDS-UPDRS) | Follow-up at 6 and 12 months | |
Secondary | Changes in cognitive function as assessed by moca | Assessed by MoCA | Follow-up at 6 and 12 months |
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