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Intermittent vs. Continuous Dorsal Root Ganglion Stimulation

Primary Purpose

Pain, Intractable, Pain, Chronic

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dorsal Root Ganglion Stimulation (DRG-S)

About this trial

This is an interventional treatment trial for Pain, Intractable focused on measuring Dorsal Root Ganglion Stimulation, Intermittent Stimulation Dosing

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is able to provide informed consent to participate in the study;
Subject is 21 years of age or older;
Subject has been treated with DRG-S permanent implant device (Abbott, Plano, TX, USA) for a minimum of 3 months with sustained pain relief >50% for chronic intractable pain;
Subject's DRG-S parameters have remained unchanged for at least 30 days prior to the beginning of the study

Exclusion Criteria:

Subject had a recent change in pain medication regimen resulting in increase in Morphine Milligram Equivalent dosing within 60 days prior to the beginning of the study
Subject received an additional pain interventional procedure within 60 days prior to the beginning of the study

Sites / Locations

Spine and Pain Institute NY

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Continuous DRG-S Dosing

1 minute on: 1 minute off Intermittent DRG-S Dosing

1 minute on: 2 minutes off Intermittent DRG-S Dosing

Arm Description

2 week stimulation program using continuous DRG-S dosing at standard stimulation parameters

2 week stimulation program using 1 minute on: 1 minute off intermittent DRG-S dosing at standard stimulation parameters

2 week stimulation program using 1 minute on: 2 minutes off intermittent DRG-S dosing at standard stimulation parameters

Outcomes

Primary Outcome Measures

Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:1 Intermittent Dosing

Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)

Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:2 Intermittent Dosing

Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)

Secondary Outcome Measures

Change in Quality of Life Between Continuous and 1:1 Intermittent Dosing

Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)

Change in Quality of Life Between Continuous and 1:2 Intermittent Dosing

Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)

Change in Disability Index Between Continuous and 1:1 Intermittent Dosing

Questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

Change in Disability Index Between Continuous and 1:2 Intermittent Dosing

Questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

Full Information

NCT ID

NCT04727216

First Posted

January 22, 2021

Last Updated

September 21, 2021

Sponsor

Spine and Pain Institute of New York

1. Study Identification

Unique Protocol Identification Number

NCT04727216

Brief Title

Intermittent vs. Continuous Dorsal Root Ganglion Stimulation

Official Title

Intermittent Dorsal Root Ganglion Stimulation Dosing Comparison to Standard Continuous Dosing in Treating Chronic Pain

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 23, 2021 (Actual)

Primary Completion Date

August 1, 2021 (Actual)

Study Completion Date

September 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Spine and Pain Institute of New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate and compare the therapeutic efficacy of intermittent Dorsal Root Ganglion Stimulation (DRG-S) to standard continuous stimulation in patients with chronic intractable pain

Detailed Description

Intermittent Dorsal Root Ganglion Stimulation (DRG-S) dosing consists of preprogrammed cycles during which stimulation is delivered with standard DRG-S parameters alternated with periods during which no stimulation is being delivered. In this study the investigators propose to evaluate therapeutic efficacy of Intermittent DRG-S at 1 minute on: 1 minute off and 1 minute on: 2 minute off dosing in comparison to standard continuous DRG-S dosing and determine if there is noninferiority between the intermittent and continuous paradigms in chronic pain patients with permanent DRG-S implants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Intractable, Pain, Chronic

Keywords

Dorsal Root Ganglion Stimulation, Intermittent Stimulation Dosing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Subjects will undergo 3 sequential 2-week dosing stimulation programs [1.) continuous, 2.) 1 minute on: 1 minute off, and 3.) 1 minute on: 2 minutes] in randomized order and double blinded fashion for a total of 6 consecutive weeks.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Participants will be blinded to which stimulation program they are receiving during each 2 week cycle. The Investigator who is also the care provider will be blinded to both the stimulation they are receiving and the sequential order they are given in. The outcomes assessor will be blinded to the sequential order of the stimulation programs each participant receives.

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuous DRG-S Dosing

Arm Type

Active Comparator

Arm Description

2 week stimulation program using continuous DRG-S dosing at standard stimulation parameters

Arm Title

1 minute on: 1 minute off Intermittent DRG-S Dosing

Arm Type

Experimental

Arm Description

2 week stimulation program using 1 minute on: 1 minute off intermittent DRG-S dosing at standard stimulation parameters

Arm Title

1 minute on: 2 minutes off Intermittent DRG-S Dosing

Arm Type

Experimental

Arm Description

2 week stimulation program using 1 minute on: 2 minutes off intermittent DRG-S dosing at standard stimulation parameters

Intervention Type

Device

Intervention Name(s)

Dorsal Root Ganglion Stimulation (DRG-S)

Intervention Description

Dorsal Root Ganglion stimulation will be delivered with continuous dosing and 2 different ON/OFF periods to compare effects for each patient.

Primary Outcome Measure Information:

Title

Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:1 Intermittent Dosing

Description

Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)

Time Frame

After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing

Title

Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:2 Intermittent Dosing

Description

Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)

Time Frame

After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing

Secondary Outcome Measure Information:

Title

Change in Quality of Life Between Continuous and 1:1 Intermittent Dosing

Description

Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)

Time Frame

After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing

Title

Change in Quality of Life Between Continuous and 1:2 Intermittent Dosing

Description

Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)

Time Frame

After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing

Title

Change in Disability Index Between Continuous and 1:1 Intermittent Dosing

Description

Questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

Time Frame

After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing

Title

Change in Disability Index Between Continuous and 1:2 Intermittent Dosing

Description

Questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

Time Frame

After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing

Other Pre-specified Outcome Measures:

Title

Stimulation Program Peference

Description

Percentage of patients preferring each stimulation program

Time Frame

6 week follow up visit after completing all 3 stimulation programs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is able to provide informed consent to participate in the study; Subject is 21 years of age or older; Subject has been treated with DRG-S permanent implant device (Abbott, Plano, TX, USA) for a minimum of 3 months with sustained pain relief >50% for chronic intractable pain; Subject's DRG-S parameters have remained unchanged for at least 30 days prior to the beginning of the study Exclusion Criteria: Subject had a recent change in pain medication regimen resulting in increase in Morphine Milligram Equivalent dosing within 60 days prior to the beginning of the study Subject received an additional pain interventional procedure within 60 days prior to the beginning of the study

Facility Information:

Facility Name

Spine and Pain Institute NY

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28030470

Citation

Deer TR, Levy RM, Kramer J, Poree L, Amirdelfan K, Grigsby E, Staats P, Burton AW, Burgher AH, Obray J, Scowcroft J, Golovac S, Kapural L, Paicius R, Kim C, Pope J, Yearwood T, Samuel S, McRoberts WP, Cassim H, Netherton M, Miller N, Schaufele M, Tavel E, Davis T, Davis K, Johnson L, Mekhail N. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. 2017 Apr;158(4):669-681. doi: 10.1097/j.pain.0000000000000814.

Results Reference

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PubMed Identifier

27150431

Citation

Miller JP, Eldabe S, Buchser E, Johanek LM, Guan Y, Linderoth B. Parameters of Spinal Cord Stimulation and Their Role in Electrical Charge Delivery: A Review. Neuromodulation. 2016 Jun;19(4):373-84. doi: 10.1111/ner.12438. Epub 2016 May 6.

Results Reference

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PubMed Identifier

33236811

Citation

Chapman KB, Yousef TA, Foster A, D Stanton-Hicks M, van Helmond N. Mechanisms for the Clinical Utility of Low-Frequency Stimulation in Neuromodulation of the Dorsal Root Ganglion. Neuromodulation. 2021 Jun;24(4):738-745. doi: 10.1111/ner.13323. Epub 2020 Nov 25.

Results Reference

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PubMed Identifier

33227827

Citation

Chapman KB, Yousef TA, Vissers KC, van Helmond N, D Stanton-Hicks M. Very Low Frequencies Maintain Pain Relief From Dorsal Root Ganglion Stimulation: An Evaluation of Dorsal Root Ganglion Neurostimulation Frequency Tapering. Neuromodulation. 2021 Jun;24(4):746-752. doi: 10.1111/ner.13322. Epub 2020 Nov 23.

Results Reference

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PubMed Identifier

31152179

Citation

Esposito MF, Malayil R, Hanes M, Deer T. Unique Characteristics of the Dorsal Root Ganglion as a Target for Neuromodulation. Pain Med. 2019 Jun 1;20(Suppl 1):S23-S30. doi: 10.1093/pm/pnz012.

Results Reference

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PubMed Identifier

23421796

Citation

Koopmeiners AS, Mueller S, Kramer J, Hogan QH. Effect of electrical field stimulation on dorsal root ganglion neuronal function. Neuromodulation. 2013 Jul-Aug;16(4):304-11; discussion 310-1. doi: 10.1111/ner.12028. Epub 2013 Feb 19.

Results Reference

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PubMed Identifier

27989460

Citation

Arcourt A, Gorham L, Dhandapani R, Prato V, Taberner FJ, Wende H, Gangadharan V, Birchmeier C, Heppenstall PA, Lechner SG. Touch Receptor-Derived Sensory Information Alleviates Acute Pain Signaling and Fine-Tunes Nociceptive Reflex Coordination. Neuron. 2017 Jan 4;93(1):179-193. doi: 10.1016/j.neuron.2016.11.027. Epub 2016 Dec 15.

Results Reference

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PubMed Identifier

31524325

Citation

Koetsier E, Franken G, Debets J, van Kuijk SMJ, Linderoth B, Joosten EA, Maino P. Dorsal Root Ganglion Stimulation in Experimental Painful Diabetic Polyneuropathy: Delayed Wash-Out of Pain Relief After Low-Frequency (1Hz) Stimulation. Neuromodulation. 2020 Feb;23(2):177-184. doi: 10.1111/ner.13048. Epub 2019 Sep 16.

Results Reference

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PubMed Identifier

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Citation

Vesper J, Slotty P, Schu S, Poeggel-Kraemer K, Littges H, Van Looy P, Agnesi F, Venkatesan L, Van Havenbergh T. Burst SCS Microdosing Is as Efficacious as Standard Burst SCS in Treating Chronic Back and Leg Pain: Results From a Randomized Controlled Trial. Neuromodulation. 2019 Feb;22(2):190-193. doi: 10.1111/ner.12883. Epub 2018 Nov 19.

Results Reference

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PubMed Identifier

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Citation

Deer TR, Patterson DG, Baksh J, Pope JE, Mehta P, Raza A, Agnesi F, Chakravarthy KV. Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation. Neuromodulation. 2021 Apr;24(3):566-573. doi: 10.1111/ner.13143. Epub 2020 Mar 23.

Results Reference

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Intermittent vs. Continuous Dorsal Root Ganglion Stimulation

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