Status unknownNCT04727216Updated Sep 22, 2021

Intermittent vs. Continuous Dorsal Root Ganglion Stimulation

An interventional study of Dorsal Root Ganglion Stimulation (DRG-S) in Pain, Intractable and Pain, Chronic, sponsored by Spine and Pain Institute of New York. Status unknown at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-22.

Sponsored by Spine and Pain Institute of New York · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 15
Allocation: Randomized
Ages: 21 Years to 75 Years
Sex: All

Study 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

Read the 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.

Conditions studied

Pain, Intractable
Pain, Chronic

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Keywords

Dorsal Root Ganglion Stimulation
Intermittent Stimulation Dosing

Who can participate

Ages eligible: 21 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 15 participants (actual)

Study arms

Active comparator
Continuous DRG-S Dosing
2 week stimulation program using continuous DRG-S dosing at standard stimulation parameters
Device: Dorsal Root Ganglion Stimulation (DRG-S)
Experimental
1 minute on: 1 minute off Intermittent DRG-S Dosing
2 week stimulation program using 1 minute on: 1 minute off intermittent DRG-S dosing at standard stimulation parameters
Device: Dorsal Root Ganglion Stimulation (DRG-S)
Experimental
1 minute on: 2 minutes off Intermittent DRG-S Dosing
2 week stimulation program using 1 minute on: 2 minutes off intermittent DRG-S dosing at standard stimulation parameters
Device: Dorsal Root Ganglion Stimulation (DRG-S)

Interventions

DeviceDorsal Root Ganglion Stimulation (DRG-S)
Dorsal Root Ganglion stimulation will be delivered with continuous dosing and 2 different ON/OFF periods to compare effects for each patient.

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Other outcomes

Stimulation Program Peference
Percentage of patients preferring each stimulation program
Time frame: 6 week follow up visit after completing all 3 stimulation programs

Study locations

1 site

Spine and Pain Institute NY
New York, New York 10065, United States

References and documents

Publications

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. PubMed 28030470 ↗
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. PubMed 27150431 ↗
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. PubMed 33236811 ↗
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. PubMed 33227827 ↗
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. PubMed 31152179 ↗
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. PubMed 23421796 ↗
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. PubMed 27989460 ↗
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. PubMed 31524325 ↗
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. PubMed 30456795 ↗
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. PubMed 32202044 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT04727216
Lead sponsor: Spine and Pain Institute of New York
Responsible party: Kenneth Chapman (Principle Investigator, Spine and Pain Institute of New York) — Principal investigator
First posted: Jan 27, 2021
Start date: Mar 23, 2021
Primary completion: Aug 1, 2021
Completion: Sep 15, 2021 (estimated)
Last update: Sep 22, 2021

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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