PET Patterns, Biomarkers and Outcome in Burst SCS Treated FBSS Patients

NCT03419312 | Unknown DMC

• 1 other identifier: IRB 2017/110/1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

FBSS; Pain, Intractable; Low Back Pain; Radicular; Neuropathic, Lumbar, Lumbosacral

Keywords

Spinal Cord Stimulation; Burst Spinal Cord Stimulation; SCS

Outcome Measures

Primary Outcomes (1)

• 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.

  PET is performed at study day 0 (baseline), day 14 and day 35.

Secondary Outcomes (10)

• Semiquantitative assessment of protein levels associated with inflammation.

  Measured at day 0 (baseline), day 14, day 21 and day 35.

• Back and leg pain

  Measured at visit day 0 (baseline), day 14 and day 35.

• General pain

  Measured at day 0 (baseline), day 14 and day 35.

• Pain inference

  Measured at day 0 (baseline), day 14 and day 35.

• Disability

  Measured at day 0 (baseline), day 14 and day 35.

Study Arms (2)

Study sequence A

EXPERIMENTAL

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

Study sequence B

EXPERIMENTAL

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

Interventions

Proclaim™ Elite 5: Burst - Washout - Sham DEVICE

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

Study sequence A

Proclaim™ Elite 5: Sham - Washout - Burst DEVICE

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

Study sequence B

Eligibility Criteria

• Age: 18 Years - 59 Years
• Gender Eligibility Details: 6 female and 6 male subjects will be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Occurrence of chronic pain in the lumbosacral region, as well as unilateral or bilateral leg pain.
• Prior lumbar surgery in medical history.
• Diagnosed with neuropathic pain in the lower extremities and graded as probable neuropathic pain or definite neuropathic pain according International Association for the Study of Pain (IASP) criteria.
• Patient report largely unchanged pain condition last 6 months.
• Patient has undergone a 7 day SCS trial with epidural burst stimulation with the following results:
• At least 75% coverage of the painful area of tonic stimulation before start of burst trial stimulation.
• At least 50% reduction in pain intensity, measured via BPI, item 5 from baseline of trial to end of trial period.
• The patient is ≥ 18 years of age and \< 60 years of age.
• The patient must willingly participate in all parts of the study, as well as having the ability to complete the entire study plan.
• Patient must certify that he / she understands the study plan, as well as voluntarily sign informed consent to participate in the study.
• Must be able to sit still for a minimum of 45 minutes and be able to follow restrictions related to the PET survey.

You may not qualify if:

• The patient has other current pain conditions than back and leg pain after back surgery.
• The patient is treated with opioids exceeding 80 milligrams of Morphine per day or is considered at risk for development of problematic opioid use.
• The patient suffers from an untreated depression or anxiety.
• The patient can not complete the study plan.
• The patient is unable to read or write Swedish.
• The patient is currently participates in another clinical trial.
• A history of previous PET scan or other substantial radiation dose in the last 5 years.
• The patients is suffering from claustrophobia.
• Ongoing pregnancy or planned pregnancy during study time.
• The patient has contraindications for arterial catheterization.
• The patient is previously treated with spinal cord stimulation.

Sponsors & Collaborators

• Uppsala University: lead
• Linkoeping University: collaborator
• Boston Children's Hospital: collaborator

Study Sites (1)

Uppsala University Hospital, Uppsala University, Dept. of Surgical Sciences and Dept. of Medicinal Chemistry, Div. of Molecular Imaging.

Uppsala, 75185, Sweden

Location

Related Publications (1)

• O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

  PMID: 34854473 DERIVED

MeSH Terms

Conditions

Pain, Intractable; Low Back Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Rolf Karlsten, MD, PhD

  rolf.karlsten@akademiska.se

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The stimulation periods with sham stimulation and burst are blinded to all included in the study except SCS nurse 1 who program and reset IPG during study phase 2. Sham stimulation is achieved by switching of the stimulation equipment in connection with programming prior to the start of the current stimulation period. The programming procedure is identical before burst and sham stimulation periods.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomized to 1 of 2 different treatment sequences: Sequence A: Active burst stimulation followed by sham stimulation. Sequence B: Sham stimulation followed by burst stimulation. Sham and burst stimulation are separated by 7 days washout.

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: February 1, 2018
• Study Start: February 11, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

SE (1)