Intermittent vs. Continuous Dorsal Root Ganglion Stimulation

NCT04727216 | Active Not Recruiting FDA Device

• 1 other identifier: Intermittent DRG-S Dosing
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Intractable; Pain, Chronic

Keywords

Dorsal Root Ganglion Stimulation; Intermittent Stimulation Dosing

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

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

Secondary Outcomes (4)

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

  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

  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

  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

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

Other Outcomes (1)

• Stimulation Program Peference

  6 week follow up visit after completing all 3 stimulation programs

Study Arms (3)

Continuous DRG-S Dosing

ACTIVE COMPARATOR

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

Device: Dorsal Root Ganglion Stimulation (DRG-S)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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

Dorsal Root Ganglion Stimulation (DRG-S) DEVICE

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

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

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spine and Pain Institute of New York: lead

Study Sites (1)

Spine and Pain Institute NY

New York, New York, 10065, United States

Location

Related Publications (10)

• 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.

  PMID: 28030470 BACKGROUND

• 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.

  PMID: 27150431 BACKGROUND

• 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.

  PMID: 33236811 BACKGROUND

• 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.

  PMID: 33227827 BACKGROUND

• 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.

  PMID: 31152179 BACKGROUND

• 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.

  PMID: 23421796 BACKGROUND

• 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.

  PMID: 27989460 BACKGROUND

• 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.

  PMID: 31524325 BACKGROUND

• 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.

  PMID: 30456795 BACKGROUND

• 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.

  PMID: 32202044 BACKGROUND

MeSH Terms

Conditions

Pain, Intractable; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: March 23, 2021
• Primary Completion: August 1, 2021
• Study Completion: September 15, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)