An interventional study of Proclaim™ Elite 5: Burst - Washout - Sham and Proclaim™ Elite 5: Sham - Washout - Burst in FBSS, Pain, Intractable and Low Back Pain, sponsored by Uppsala University. Status unknown at 1 site in Sweden. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2020-04-08.
Sponsored by Uppsala University · Not applicable, Interventional, and Basic science
The primary aim of this study is to investigate cerebral mechanisms of burst stimulation in Failed Back Surgery Syndrome (FBSS) patients treated with Burst Spinal Cord Stimulation (SCS) for chronic back and leg pain. This study is a single center, prospective, blinded, randomized crossover trial with two 14 days treatment periods and two treatment arms (burst before sham stimulation or sham before burst stimulation).
Background and rationale:
Tonic spinal cord stimulation for chronic primarily neuropathic pain har been used for over 50 years. Tonic stimulation in frequencies from 20 to 70 Hz produces analgesia and paresthesia in the targeted area.
Burst stimulation, a novel spinal cord stimulation pattern, is an intermittent high frequency parenthesis-free therapy. This stimulation pattern consist of 5 spikes with an inter-spike frequency of 500 Hz, delivered at 40 Hz.
Clinical effectiveness and noninferiority of Burst stimulation has been proved. A few studies suggest that Burst stimulation induce different activities in cerebral pathways, compared with tonic stimulation. Patient reported attention to pain assessed by the pain vigilance and awareness questionnaire (PVAQ) seems to differ between burst and tonic spinal cord stimulation. This trial is designed to investigate cerebral mechanisms of burst stimulation, using PET O15-water measured blood flow and tissue perfusion as a proxy for cerebral activity.
Key events in study implementation:
Study phase 1
Study phase 2:
90 studies on the registry are indexed under Pain, Intractable; 16 are open to participants now.
This study's planned enrollment of 12 is below the median of 60 across 64 interventional studies indexed under Pain, Intractable.
Browse Pain, Intractable studies →Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient has undergone a 7 day SCS trial with epidural burst stimulation with the following results:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proclaim™ Elite 5: Burst - Washout - Sham 1. 14 days of burst stimulation. 2. 7 days washout. 3. 14 days of sham stimulation.
Device: Proclaim™ Elite 5: Burst - Washout - Sham
Proclaim™ Elite 5: Sham - Washout - Burst 1. 14 days of sham stimulation. 2. 7 days washout. 3. 14 days of burst stimulation.
Device: Proclaim™ Elite 5: Sham - Washout - Burst
All implanted hardware manufactured by S:t Jude Medical/Abbot: Implantable Pulse Generator (IPG): Proclaim™ Elite 5 IPG, model 3660. Electrode: Octrode percutaneous lead, 60 cm, model 3161. Anchor: Long lead anchor, model 1106.
Also known as: Burst DR, Spinal Cord Stimulation
All implanted hardware manufactured by S:t Jude Medical/Abbot: Implantable Pulse Generator (IPG): Proclaim™ Elite 5 IPG, model 3660. Electrode: Octrode percutaneous lead, 60 cm, model 3161. Anchor: Long lead anchor, model 1106.
Also known as: Burst DR, Spinal Cord Stimulation
Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET)
35 Volume of Interest (VOI) will be applied to each PET scan using the PVElab software. Cerebral blood flow (CBF) and perfusable tissue fraction (PTF) will be calculated for each VOI at each scan. Same tests will be done at voxel level with the Statistical Parameter Mapping Software (SPM12), to identify areas with changed CBF or PTF that do not correspond to VOI in the template.
Time frame: PET is performed at study day 0 (baseline), day 14 and day 35.
Semiquantitative assessment of protein levels associated with inflammation.
Level of normalized protein expression (NPX) in plasma, assessed by a multiplex proximity extension assay panel (Olink Bioscience, Uppsala, Sweden).
Time frame: Measured at day 0 (baseline), day 14, day 21 and day 35.
Back and leg pain
Measured using a 100mm Visual Analog Scale (VAS) for back and leg pain, respectively. Scale range: 0 mm indicates no pain (minimum), 100 mm indicates worst imaginable pain (maximum).
Time frame: Measured at visit day 0 (baseline), day 14 and day 35.
General pain
General pain measured by Brief Pain Inventory (BPI) item 3, 4, 5 and 6
Time frame: Measured at day 0 (baseline), day 14 and day 35.
Pain inference
Measured by BPI item 9A-9G
Time frame: Measured at day 0 (baseline), day 14 and day 35.
Disability
Disability measured by Oswestry Disability Index (ODI).
Time frame: Measured at day 0 (baseline), day 14 and day 35.
Pain Catastrophizing
Measured by Pain Catastrophizing Scale (PCS).
Time frame: Measured at day 0 (baseline), day 14 and day 35.
Pain Vigilance and Awareness
Measured by the Pain Vigilance and Awareness Questionnaire (PVAQ).
Time frame: Measured at day 0 (baseline), day 14 and day 35.
Global Impression of Change
Impression of change in health status assessed by the inventory Patient Global Impression of Change (PGIC).
Time frame: Measured at day 14 and day 35.
Depression
Symptoms of depression is assessed by the inventory Patient Health Questionnaire (PHQ-9).
Time frame: Measured at day 0 (baseline), day 14 and day 35.
Anxiety
Symptoms of anxiety is assessed by the inventory Generalized Anxiety Disorder Screener (GAD-7).
Time frame: Measured at day 0 (baseline), day 14 and day 35.
Plan to share: Undecided
Started Feb 2018 (actual). Primary completion is estimated for Jun 2021, 40 months after the start.
Of 26 interventional studies with no phase under Pain, Intractable, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 34. This study's planned 40 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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