Ultra Low Frequency Spinal Cord Stimulation for Chronic Low Back Pain

NCT05837234 | Active Not Recruiting DMC FDA Device

• 1 other identifier: PMH-003
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

Brief Summary

The Presidio Medical Ultra Low Frequency (ULF™) Spinal Cord Stimulation (SCS) System is intended to provide pain relief to participants who have been clinically diagnosed with chronic low back pain with or without leg pain.

Conditions

Chronic Pain; Chronic Low-back Pain

Keywords

Neuromodulation; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• Back pain responder rate at 3 months as assessed using a visual analog scale (VAS)

  A responder is defined as a participant that achieved at least 50% reduction in back pain at the follow-up compared to baseline. Responder rate is defined as the percentage of participants that were responders.

  3 months

Secondary Outcomes (18)

• Change in back pain VAS at 3 months

  3 months

• Change in back pain VAS at 6 months

  6 months

• Change in back pain VAS at 12 months

  12 months

• Change in leg pain VAS at 3 months

  3 months

• Change in leg pain VAS at 6 months

  6 months

Study Arms (1)

ULF SCS

EXPERIMENTAL

Participants with chronic low back pain that is refractory to conservative care will undergo temporary trial stimulation with the ULF SCS system. Those receiving at least 50% pain relief of their chronic back pain will be eligible for a permanent device implant and followed for 24 months.

Device: ULF SCS

Interventions

ULF SCS DEVICE

Ultra low frequency spinal cord stimulation

ULF SCS

Eligibility Criteria

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

You may qualify if:

• Diagnosed with chronic low back pain with/without leg pain (VAS ≥60mm for back pain for the past week), which has been refractory to conservative therapy for a minimum of 3 months.
• Be on no or stable pain medications, as determined by the investigator, for at least 28 days prior to the screening visit.
• Is currently considered medically stable as judged by investigator.
• Able to operate the SCS device (e.g., using remote control) and charge the device appropriately.
• Determined to be a good surgical candidate by the investigator.
• Willing to sign the Human Research Ethics Committee (HREC) approved informed consent and deemed capable of complying with the requirements of the study protocol.
• Willing to stay on stable medications until implantable pulse generator (IPG) activation (i.e., from IPG implant to IPG activation, except for usual postoperative medications required following IPG insertion).
• Able to comply with study requirements and attend all scheduled visits.
• Eighteen (18) years of age or older.
• Literate, able to speak English and able to complete questionnaires independently.

You may not qualify if:

• Diagnosis of active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance, intervention and/or ability to evaluate treatment outcome as assessed by a clinical psychologist or psychiatrist in a psychological assessment performed at Baseline.
• Chronic pain in any area other than back or legs, such that it precludes subject's ability to assess their pain for the primary indication of chronic low back pain as determined by Investigator.
• Previous experience with implantable neuromodulation devices (e.g., spinal cord stimulation, peripheral nerve stimulation, dorsal root ganglion stimulation).
• Opioid usage with average total daily morphine equivalent dose (MED) of \>60 mg.
• A known need for an MRI or surgery within a 2-week period of the screening visit through the end of the study.
• Female candidates of childbearing potential that are pregnant (confirmed by positive urine/blood pregnancy test) or plan to get pregnant during the duration of the study.
• Subject is participating in another interventional clinical trial.

Sponsors & Collaborators

• Presidio Medical, Inc: lead

Study Sites (3)

Genesis Research Services Pty Ltd

Newcastle, New South Wales, Australia

Location

CerCare Pty Ltd

Wayville, South Australia, Australia

Location

Monash House Research Centre

Clayton, Victoria, 3168, Australia

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Willem Volschenk, MBCHB

  Genesis Research Services

  PRINCIPAL INVESTIGATOR

• Mattew Green, BMBS

  CerCare

  PRINCIPAL INVESTIGATOR

• Paul Verrills, MBBS

  Monash House Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: May 9, 2023
• Primary Completion: May 19, 2025
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)