search
Back to results

Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

Primary Purpose

Chronic Pain, Pain, Neuropathic, Neuropathic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Cord Stimulator
Spinal Cord Stimulator
Sponsored by
Ashwin Viswanathan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, Spinal Cord Stimulation, Spinal cord, Neuropathy

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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 >6 on the Numerical Rating Scale collected with a 7-day pain diary related to pain of the trunk 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. No new pain medication will be added 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 Exclusion Criteria: Patient exhibits catastrophization based on physician evaluation (e.g., average overall daily pain intensity of 10 on a 0-10 numerical rating 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

Sites / Locations

  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Time Invariant Pulse(TIP) Stimulation

Time Variant Pulse (TVP) Stimulation

Arm Description

The control arm for this study will be the Time Invariant Pulse stimulation which is used in standard of care Spinal Cord Stimulation therapy. TIP tonic stimulation is delivered with fixed amplitude, pulse width, and frequency parameters.

The time variant pulse (TVP) stimulation will serve as the experimental arm for this study. There are two ways of delivering TVP stimulation to the spinal cord. TVP stimulation can either vary in intensity or it can vary rate, referred to as intensity-modulated TVP or rate-modulated TVP, respectively.

Outcomes

Primary Outcome Measures

Change in Patient responder rate
The primary endpoint for this trial will be a comparison of the percentage of patients achieving at least a 50% reduction in pain during the TIP stimulation block with the percentage of patients achieving at least a 50% reduction in pain during either TVP stimulation block.

Secondary Outcome Measures

Full Information

First Posted
July 7, 2023
Last Updated
August 16, 2023
Sponsor
Ashwin Viswanathan
Collaborators
Boston Scientific Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT05968664
Brief Title
Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation
Official Title
Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ashwin Viswanathan
Collaborators
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The researchers will conduct a traditional exploratory feasibility study using an investigational device to compare the clinical outcomes using time varying pulse (TVP) waveforms against time-invariant pulse (TIP) waveforms using both paresthesia and paresthesia-free SCS therapies. The therapy longevity of TVPs and TIPS will also be evaluated by tracking therapy efficacy through a long-term follow-up phase, using multiple pain assessments and at-home digital data collection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Pain, Neuropathic, Neuropathic Pain
Keywords
Chronic pain, Spinal Cord Stimulation, Spinal cord, Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time Invariant Pulse(TIP) Stimulation
Arm Type
Active Comparator
Arm Description
The control arm for this study will be the Time Invariant Pulse stimulation which is used in standard of care Spinal Cord Stimulation therapy. TIP tonic stimulation is delivered with fixed amplitude, pulse width, and frequency parameters.
Arm Title
Time Variant Pulse (TVP) Stimulation
Arm Type
Experimental
Arm Description
The time variant pulse (TVP) stimulation will serve as the experimental arm for this study. There are two ways of delivering TVP stimulation to the spinal cord. TVP stimulation can either vary in intensity or it can vary rate, referred to as intensity-modulated TVP or rate-modulated TVP, respectively.
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulator
Intervention Description
Spinal Cord Stimulator modified to deliver Time Variant Pulse (TVP) stimulation.
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulator
Intervention Description
Spinal Cord Stimulator to deliver standard of care Time Invariant Pulse (TIP) stimulation.
Primary Outcome Measure Information:
Title
Change in Patient responder rate
Description
The primary endpoint for this trial will be a comparison of the percentage of patients achieving at least a 50% reduction in pain during the TIP stimulation block with the percentage of patients achieving at least a 50% reduction in pain during either TVP stimulation block.
Time Frame
Patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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 >6 on the Numerical Rating Scale collected with a 7-day pain diary related to pain of the trunk 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. No new pain medication will be added 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 Exclusion Criteria: Patient exhibits catastrophization based on physician evaluation (e.g., average overall daily pain intensity of 10 on a 0-10 numerical rating 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashwin Viswanathan, MD
Phone
7132138181
Email
ashwinv@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Luke Jan Gelvoligaya, MA
Phone
7137987245
Email
lukejan.gelvoligaya@bcm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashwin Viswanathan, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aswhin Viswanathan, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

We'll reach out to this number within 24 hrs