RECRUITING

Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

Conditions

Chronic Pain Pain, Neuropathic Neuropathic Pain Spinal Cord Stimulation Spinal cord Neuropathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS) using time varying stimulation patterns with pain outcomes achieved by current standard of care SCS.

Official Title

Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

Quick Facts

Study Start:2024-08-01

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05968664

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Ability to provide informed consent * Age ≥ 22 * Chronic pain of the trunk and/or limbs for at least 6 months * Baseline average daily overall pain score of \>60 (on a scale of 0-100mm) on the Visual Analog Scale related to pain of the back and/or limbs * Failed ≥3 medically supervised treatments (i.e. pain medications, physical therapy, facet joint/medial branch nerve blocks, acupuncture), and treatment with \>2 classes of medications * Stable pain-related medication regimen 4 weeks prior to the trial. Patients will be asked to not increase or add pain-related medication during the study period * No back surgery within 6 months prior to Screening * Consumed an average total daily morphine equivalent of ≤200 mg during the 30 days prior to Screening. * Baseline Oswestry Disability Index score ≥40 and ≤80 * Eligible candidate for SCS from a psychological and psychiatric standpoint as determined within 180 days prior to Baseline Visit, per site's routine screening process * Able to independently read and complete all questionnaires and assessments provided in English * Female candidates of child-bearing potential agree to use contraception during the study period * Deemed to be a good candidate for spinal cord stimulation by the PI, and a board certified pain management physician * Willing to cooperate with study requirements	* Patient exhibits catastrophization based on physician evaluation (e.g., average overall daily pain intensity of 100 on a 0-100mm visual analog scale, every day during the 7 days prior to Screening, based on patient recall * Pain originating from peripheral vascular disease * Active treatment for cancer in past 6 months * Involved in disability litigation * High surgical risk including documented history of allergic response to titanium or silicone, current systemic infection, or local infection in close proximity to anticipated surgical field * Body mass index ≥ 45 at Screening * Terminal illness with anticipated survival \< 12 months * Participant is immunocompromised * Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study * Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study * Previous spinal cord stimulation trial/implant or is already implanted with an active implantable device(s) (e.g. drug pump, implantable pulse generator) * A pregnant female or a female of childbearing potential planning to get pregnant during the course of the study * Plan to receive any massage or manipulation directly over the leads or by the anticipated location of the IPG or treatments that involve sudden jerking motions of the torso at any * Existing medical condition that is likely to require the use of diathermy * Any injury or medical/psychological condition that might be significantly exacerbated by the implant surgery or the presence of an implantable stimulator or otherwise compromise subject safety * Unable to operate the study devices including wrist-worn biosensor and mobile app * Documented history of substance abuse or dependency in the 6 months prior to baseline

Inclusion Criteria

Exclusion Criteria

* Ability to provide informed consent
* Age ≥ 22
* Chronic pain of the trunk and/or limbs for at least 6 months
* Baseline average daily overall pain score of \>60 (on a scale of 0-100mm) on the Visual Analog Scale related to pain of the back and/or limbs
* Failed ≥3 medically supervised treatments (i.e. pain medications, physical therapy, facet joint/medial branch nerve blocks, acupuncture), and treatment with \>2 classes of medications
* Stable pain-related medication regimen 4 weeks prior to the trial. Patients will be asked to not increase or add pain-related medication during the study period
* No back surgery within 6 months prior to Screening
* Consumed an average total daily morphine equivalent of ≤200 mg during the 30 days prior to Screening.
* Baseline Oswestry Disability Index score ≥40 and ≤80
* Eligible candidate for SCS from a psychological and psychiatric standpoint as determined within 180 days prior to Baseline Visit, per site's routine screening process
* Able to independently read and complete all questionnaires and assessments provided in English
* Female candidates of child-bearing potential agree to use contraception during the study period
* Deemed to be a good candidate for spinal cord stimulation by the PI, and a board certified pain management physician
* Willing to cooperate with study requirements

* Patient exhibits catastrophization based on physician evaluation (e.g., average overall daily pain intensity of 100 on a 0-100mm visual analog scale, every day during the 7 days prior to Screening, based on patient recall
* Pain originating from peripheral vascular disease
* Active treatment for cancer in past 6 months
* Involved in disability litigation
* High surgical risk including documented history of allergic response to titanium or silicone, current systemic infection, or local infection in close proximity to anticipated surgical field
* Body mass index ≥ 45 at Screening
* Terminal illness with anticipated survival \< 12 months
* Participant is immunocompromised
* Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
* Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
* Previous spinal cord stimulation trial/implant or is already implanted with an active implantable device(s) (e.g. drug pump, implantable pulse generator)
* A pregnant female or a female of childbearing potential planning to get pregnant during the course of the study
* Plan to receive any massage or manipulation directly over the leads or by the anticipated location of the IPG or treatments that involve sudden jerking motions of the torso at any
* Existing medical condition that is likely to require the use of diathermy
* Any injury or medical/psychological condition that might be significantly exacerbated by the implant surgery or the presence of an implantable stimulator or otherwise compromise subject safety
* Unable to operate the study devices including wrist-worn biosensor and mobile app
* Documented history of substance abuse or dependency in the 6 months prior to baseline

Contacts and Locations

Study Contact

Ashwin Viswanathan, MD

CONTACT

7132138181

ashwinv@bcm.edu

Luke Jan Gelvoligaya, MA

CONTACT

7137987245

lukejan.gelvoligaya@bcm.edu

Principal Investigator

Ashwin Viswanathan, MD

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Study Locations (Sites)

Baylor College of Medicine

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Ashwin Viswanathan

Ashwin Viswanathan, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01

Study Completion Date2028-01

Study Record Updates

Study Start Date2024-08-01

Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

Chronic pain
Spinal Cord Stimulation
Spinal cord
Neuropathy

Additional Relevant MeSH Terms

Chronic Pain
Pain, Neuropathic
Neuropathic Pain