Comparison of Continuous and Burst High Frequency Spinal Cord Stimulation Paradigms

NCT04709757 | Withdrawn

• 1 other identifier: 20121301
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Spinal cord stimulation (SCS) delivered at 10kHz frequency (HF10 Therapy) has demonstrated superiority to traditional SCS for leg and back pain. Intermittent dosing (ID) refers to the cycling of stimulation, in which there is a designated time period of stimulation being active (ON) and inactive (OFF). Previous studies have demonstrated the safe and effective use of intermittent dosing. However, there still remains a paucity of clinical data on the use of intermittent dosing and which doses (i.e. on/off cycle time periods) are most effective. Furthermore, no previous studies have utilized HF10 therapy when evaluating intermittent dosing. Patients with chronic back and/or leg pain who have undergone permanent spinal cord stimulator implantation delivered by the Nevro Omnia Neurostimulation System and who are reporting decreased efficacy of continuous HF10 therapy will be randomized into one of two treatments: 1) Intermittent Dosing therapy at 30 seconds ON, 90 seconds OFF 2)Intermittent Dosing therapy at 30 seconds ON, 360 seconds OFF. After randomization, each consented subject will present to clinic at which time will first be seen by a team of investigators, sub-investigators, and/or study staff. After evaluation and collection of baseline data, a clinical specialist for the Nevro Omnia Neurostimulation system will program the subject's SCS system according to the treatment group to which they have been randomized, under direct physician supervision Patient's will be seen and evaluated prior to randomization, and thereafter at 2, 4 and 6 weeks. At the 6-week time period, patients will be crossed over to the other study arm and thereafter evaluated at 2, 4 and 6 weeks. As our primary endpoint, we hypothesize that ID HF10 therapy will provide non-inferior pain relief as measured by VAS scores when compared to continuous HF10 therapy. Other endpoints include: charging frequency, EQ-5D scores of wellbeing; PROMIS score for physical function, pain interference, sleep disturbance, and emotional distress; chronic pain acceptance questionnaire 8 (CPAQ-8), patient satisfaction scores, and patient global impression of change

Conditions

Chronic Low-back Pain; CRPS; Peripheral Neuropathy

Keywords

Chronic pain; Spinal cord stimulation; CRPS

Outcome Measures

Primary Outcomes (1)

• NRS pain scores

  Subject's Numeric Rating Scale (NRS) score for pain being treated by spinal cord 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 3 months

Secondary Outcomes (15)

• Patient Satisfaction with Treatment Score

  Up to 3 months

• CPAQ-8

  Up to 3 months

• Current mode of stimulation

  Up to 3 months

• Stimulator settings- frequency

  Up to 3 months

• Stimulator settings- amplitude

  Up to 3 months

Study Arms (2)

Intermittent Dosing HF10 30/90

ACTIVE COMPARATOR

Stimulation delivered at 30 seconds ON and 120 seconds OFF through patient's existing spinal cord stimulator.

Device: Intermittent Dosing HF10 30/90

Intermittent Dosing HF10 30/360

ACTIVE COMPARATOR

Stimulation delivered at 30 seconds ON and 360 seconds OFF through patient's existing spinal cord stimulator.

Device: Intermittent Dosing HF10 30/360

Interventions

Intermittent Dosing HF10 30/90 DEVICE

10kHz frequency spinal cord stimulation delivered at 30 seconds ON and 120 seconds OFF

Intermittent Dosing HF10 30/90

Intermittent Dosing HF10 30/360 DEVICE

10kHz frequency spinal cord stimulation delivered at 30 seconds ON and 360 seconds OFF

Intermittent Dosing HF10 30/360

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 90
• year or more use of continuous HF10 therapy as delivered a permanently implanted Nevro Omnia Neurostimulation System for chronic back and/or leg pain
• Some level of decreasing pain relief from their SCS system (see fig. 3)
• 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:

• Previous intermittent dosing usage and/or failure
• Cervical SCS system
• Other concurrent neuromodulation system in place
• Current daily morphine milligram equivalent usage 90mg or higher

Sponsors & Collaborators

• Rush University Medical Center: lead

Related Publications (10)

• 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

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert J McCarthy, PharmD

  Rush University Medical Center

  STUDY DIRECTOR

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 assigned.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized to receive 1) Intermittent Dosing Therapy 30 seconds ON 90 seconds OFF or 2) Intermittent Dosing Therapy 30 seconds ON and 360 seconds OFF Patients will be seen and evaluated prior to randomization, and thereafter at 2, 4 and 6 weeks. At the 6-week time period, patients will be crossed over to the other study arm and thereafter evaluated at 2, 4 and 6 weeks.

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 14, 2021
• Study Start: August 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share