NCT04159753

Brief Summary

Researchers are evaluating if subjects who have already experienced tonic spinal cord stimulation would have a better pain relief status with burst spinal cord stimulation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2021

Completed
Last Updated

January 18, 2022

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

November 8, 2019

Last Update Submit

January 3, 2022

Conditions

Chronic Pain

Keywords

Spinal cord stimulator (SCS)

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

    Change in Pain scores using Numeric Rating Scale (1-10)

    Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends

  • Pain quality, intensity and localization

    Change in pain perception using Short-Form McGill Pain Questionnaire-2

    Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends

  • Pain perception

    Change in pain perception using the Pain Catastrophizing Scale self-reported survey

    Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends

Secondary Outcomes (4)

  • Depression

    Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends

  • Functioning

    Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends

  • Participant self-evaluation of Quality of Life

    Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends

  • Participant's impression of Quality of Life

    Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends

Study Arms (1)

Spinal Cord Stimulator

OTHER

Burst neurostimulation

Device: Spinal Cord Stimulator

Interventions

Spinal Cord StimulatorDEVICE

We will record patient's experience on the 30-Day FDA approved Burst Spinal Cord Stimulator Trial (BurstDR™, Abbott Saint Jude Medical).

Also known as: Neurostimulator
Spinal Cord Stimulator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females ≥18 years-old
  • Diagnosed with chronic pain
  • Have an already-implanted Eon Family IPG for a minimum period of 6 months
  • Are interested in trying burst technology by reprograming their IPG for 2-3 weeks according to the 30-Day Trial standard of care
  • Signed informed consent

You may not qualify if:

  • Subject's overall Beck Depression Inventory II Score is \>24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the screening visit; If subjects scores indicate suicidal thoughts, subject is going to be evaluated further if they will be subjects to Baker's act
  • Subject is currently receiving, applying or considering seeking disability payments, workers compensation, or is involved in disability litigation
  • Subject has an infusion pump or any other implantable neurostimulator device
  • Subjects with a separate, concurrent, clinically significant or disabling chronic pain problem that requires additional medical or surgical treatment
  • Subject's pain originates from peripheral vascular disease
  • Subject is immunocompromised
  • Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
  • Subject has history of cancer requiring active treatment in the last 6 months
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Chronic Pain

Interventions

Implantable Neurostimulators

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and Implants

Study Officials

  • Michael Osborne, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 12, 2019

Study Start

October 10, 2019

Primary Completion

April 14, 2021

Study Completion

April 14, 2021

Last Updated

January 18, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)