Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy

NCT04909138 | Recruiting FDA Device

• 1 other identifier: 21051403
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to evaluate the use of intermittent dosing as an alternative paradigm for patients with DRG stimulation in place for at least 1 year and minimum 50% pain relief in the targeted area. Patients will be prospectively randomized to one of two stimulation paradigms both of which involve intermittent dosing at 30 seconds ON and 90 seconds OFF. Group 1 will have their frequency set at 20 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation). Group 2 will have their frequency set at 5 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation) This study will be performed in a crossover fashion, meaning patients will be changed to the alternate dosing regimen at the 13-week time period. Patients will be seen and evaluated prior to randomization and reprogramming, and thereafter evaluated at 4, 8, and 12-weeks. At the 12-week time period, patients will begin a 1-week washout period of continuous stimulation. At the 13-week time period, patients will be evaluated, crossed over to the other study arm and thereafter evaluated at 17, 21, and 25-weeks.

Conditions

CRPS (Complex Regional Pain Syndromes); Radiculopathy; Peripheral Neuropathy

Keywords

Chronic Pain; Dorsal Root Ganglion Stimulation

Outcome Measures

Primary Outcomes (1)

• NRS pain scores

  Subject's Numeric Rating Scale (NRS) score for pain being treated by DRG simulation for up to 3 months of designated treatment on a 22 point scale from 0-10 in 0.5 increments with 0 being no pain to 10 being the worse imaginable pain.

  Up to 6 months

Secondary Outcomes (15)

• Patient Satisfaction with Treatment Score

  Up to 6 months

• CPAQ-8

  Up to 6 months

• Current mode of stimulation

  Up to 6 months

• Stimulator settings- frequency

  Up to 6 months

• Stimulator settings- amplitude

  Up to 6 months

Study Arms (2)

DRG stimulation therapy at 20 Hz and 30 seconds ON, 90 seconds OFF

ACTIVE COMPARATOR

DRG stimulation therapy at 20 Hz (30 seconds ON, 90 seconds OFF)

Device: DRG stimulation 20 Hz 30/90

DRG stimulation therapy at 5 Hz and 30 seconds ON, 90 seconds OFF

ACTIVE COMPARATOR

DRG stimulation therapy at 5 Hz (30 seconds ON, 90 seconds OFF)

Device: DRG stimulation 5 Hz 30/90

Interventions

DRG stimulation 20 Hz 30/90 DEVICE

Stimulation delivered at 20 Hz and 30 seconds ON, 90 seconds OFF

DRG stimulation therapy at 20 Hz and 30 seconds ON, 90 seconds OFF

DRG stimulation 5 Hz 30/90 DEVICE

Stimulation delivered at 5 Hz and 30 seconds ON, 90 seconds OFF

DRG stimulation therapy at 5 Hz and 30 seconds ON, 90 seconds OFF

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 99
• year or more use of continuous DRG therapy as delivered a permanently implanted Abbott PROCLAIM XR Dorsal Root Ganglion Neurostimulator System for chronic back and/or leg pain
• Endorse at least 50% pain relief in the targeted area over the last year
• Must have been seen for routine follow-up within last 4 months
• Must have been reprogrammed in standard fashion at least once prior to randomization
• Willing and able to complete protocol requirements, including:
• Complete health questionnaires and pain scales as specified in the protocol
• Sign the study-specific informed consent form
• Complete follow-ups at the designated time periods

You may not qualify if:

• Significant lead migration, as determined by clinician
• Other concurrent neuromodulation system in place
• Corticosteroid injection in previous 30 days prior to enrollment
• Intermittent dosing and/or failure within last 6m
• Changing or unstable pain medications within 30 days

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (11)

• Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Brown LL, Yearwood TL, Bundschu R, Burton AW, Yang T, Benyamin R, Burgher AH. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015 Oct;123(4):851-60. doi: 10.1097/ALN.0000000000000774.

  PMID: 26218762 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

• Deer T, Slavin KV, Amirdelfan K, North RB, Burton AW, Yearwood TL, Tavel E, Staats P, Falowski S, Pope J, Justiz R, Fabi AY, Taghva A, Paicius R, Houden T, Wilson D. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. doi: 10.1111/ner.12698. Epub 2017 Sep 29.

  PMID: 28961366 BACKGROUND

• Alo KM, Redko V, Charnov J. Four Year Follow-up of Dual Electrode Spinal Cord Stimulation for Chronic Pain. Neuromodulation. 2002 Apr;5(2):79-88. doi: 10.1046/j.1525-1403.2002.02017.x.

  PMID: 22151846 BACKGROUND

• Turner JA, Loeser JD, Deyo RA, Sanders SB. Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications. Pain. 2004 Mar;108(1-2):137-47. doi: 10.1016/j.pain.2003.12.016.

  PMID: 15109517 BACKGROUND

• Hayek SM, Veizi E, Hanes M. Treatment-Limiting Complications of Percutaneous Spinal Cord Stimulator Implants: A Review of Eight Years of Experience From an Academic Center Database. Neuromodulation. 2015 Oct;18(7):603-8; discussion 608-9. doi: 10.1111/ner.12312. Epub 2015 Jun 5.

  PMID: 26053499 BACKGROUND

• Pope JE, Deer TR, Falowski S, Provenzano D, Hanes M, Hayek SM, Amrani J, Carlson J, Skaribas I, Parchuri K, McRoberts WP, Bolash R, Haider N, Hamza M, Amirdelfan K, Graham S, Hunter C, Lee E, Li S, Yang M, Campos L, Costandi S, Levy R, Mekhail N. Multicenter Retrospective Study of Neurostimulation With Exit of Therapy by Explant. Neuromodulation. 2017 Aug;20(6):543-552. doi: 10.1111/ner.12634. Epub 2017 Jul 17.

  PMID: 28714533 BACKGROUND

• Van Buyten JP, Wille F, Smet I, Wensing C, Breel J, Karst E, Devos M, Poggel-Kramer K, Vesper J. Therapy-Related Explants After Spinal Cord Stimulation: Results of an International Retrospective Chart Review Study. Neuromodulation. 2017 Oct;20(7):642-649. doi: 10.1111/ner.12642. Epub 2017 Aug 18.

  PMID: 28834092 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

• Chao D, Zhang Z, Mecca CM, Hogan QH, Pan B. Analgesic dorsal root ganglionic field stimulation blocks conduction of afferent impulse trains selectively in nociceptive sensory afferents. Pain. 2020 Dec;161(12):2872-2886. doi: 10.1097/j.pain.0000000000001982.

  PMID: 32658148 BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Radiculopathy; Peripheral Nervous System Diseases; Chronic Pain

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert McCarthy, PharmD

  Rush University Medical Center

  STUDY DIRECTOR

Central Study Contacts

Sandeep Amin, MD

CONTACT

3129422966; sandeep_amin@rush.edu

Daniel Torrez, BS

CONTACT

312-942-2741; Daniel_Torrez@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know to which treatment they are randomized
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator- Anesthesia Department (Provider)

Model Details: Patients will be prospectively randomized to one of two stimulation paradigms both of which involve intermittent dosing at 30 seconds ON and 90 seconds OFF. Group 1 will have their frequency set at 20 Hz with amplitude set just below perception. Group 2 will have their frequency set at 5 Hz with amplitude set just below perception. This study will be performed in a crossover fashion with a washout period, meaning patients will receive one of the stimulation parameters at baseline, return to their pre-study stimulation settings at the 12-week time period and receive the alternate stimulation dosing regimen at the 13-week time period.

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: October 15, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)