Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain

NCT03543085 | Completed Results

• 1 other identifier: PT1710001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-arm, open label, single center to confirm the effectiveness and safety of an ultra-high frequency (500 KHz) spinal cord stimulation in patients with chronic back pain or lower limb pain.

Conditions

Pain, Chronic; Pain, Back; Pain, Radiating

Outcome Measures

Primary Outcomes (2)

• Change in Visual Analog Score From Baseline to Day 14

  To assess the analgesic effectiveness of ultra-high frequency spinal cord stimulation, as measured by Visual Analogue Scale (VAS, score min 0 no pain to max 10 worst pain) compared to baseline.

  14 days

• Record Incidence of Adverse Events

  To evaluate safety of ultra-high frequency spinal cord stimulation by identifying the incidence rate of adverse events (AEs) and serious adverse events (SAEs) during the trial

  14 days

Secondary Outcomes (4)

• The Brief Pain Inventory (BPI)

  14 days

• Incidence of Stimulation-induced Paresthesia

  14 days

• Pain Relief Medication Consumption

  14 days

• Oswestry Low Back Pain Disability Questionnaire (ODI)

  14 days

Study Arms (1)

Ultrahigh Frequency (500 KHz) Stimulation

EXPERIMENTAL

This study is a prospective, single-arm, open label, single center to confirm the effectiveness and safety of an ultrahigh frequency spinal cord stimulation in patients with chronic back pain or lower limb pain.

Device: GiMer Medical MN 1000 External Stimulator

Interventions

GiMer Medical MN 1000 External Stimulator DEVICE

Trial stimulator (GiMer Medical Model 1000 External Stimulator) to generate pulsed ultrahigh frequency (\>200KHz) electrical stimulation, delivered via lead in epidural space, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.

Ultrahigh Frequency (500 KHz) Stimulation

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≧20 and ≦75
• Have a symptom of back or lower limb pain with a diagnosis related to spinal lesion, herniated disc, nerve injury, stenosis, failed back surgery syndrome (FBSS), complex regional pain syndrome (CRPS) or ischemic lower limb pain and have pain history of \>6 months.
• Has failed to achieve adequate pain relief from prior pharmacologic treatments.
• In the judgement of the investigator, the subject is an appropriate candidate for the trial procedure.
• The subject is willing and able to comply with the procedure and requirements of this trial.
• The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with Institutional Review Board (IRB) requirements.

You may not qualify if:

• Have evidence of a mental or psychological condition that affects pain perception and has difficulty/disability performing objective pain assessment, or have previously failed mental or psychological assessments administered by a psychiatrist that may be deemed to indicate the subject's lack of suitability for participation in this study.
• Subject has exhibited unstable pain condition within the past 30 days as interviewed by Investigator.
• Be on anticoagulant medication with International Normalized Ratio (INR) \>1.5 or platelet count less than 100,000/μL, peripheral vascular diseases (PVDs), visceral pain or uncontrolled Diabetes mellitus (DM).
• Has had corticosteroid therapy at an intended site of stimulation within the past 30 days.
• Pain medication(s) dosages(s) are not stable for at least 30 days at investigator's discretion.
• Currently has an active implantable device including International Classification of Diseases (ICD), pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy.
• Have a current diagnosis of cancer with active symptoms.
• Have a known terminal illness with life expectancy less than one year.
• Have a systematic or local infection, which may increase study risk.
• Currently has an indwelling device that may pose an increased risk of infection.
• Be pregnant or breast feeding.
• Have a medical history of drug or alcohol addiction within the past 2 years.
• Participation in any investigational study in the last 30 days or current enrollment in any trial.
• Be currently involved in an injury claim law suit or medically related litigation, including workers compensation.
• Be a prisoner.

Sponsors & Collaborators

• GiMer Medical: lead
• China Medical University Hospital: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Chronic Pain; Back Pain; Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Yeong-Ray Wen (Department of Anaesthesia)
• Organization: China Medical University Hospital (in Taiwan)

yray.wen@gmail.com

+886 4 2205-2121

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: May 18, 2018
• First Posted: June 1, 2018
• Study Start: April 12, 2018
• Primary Completion: October 23, 2018
• Study Completion: October 23, 2018
• Last Updated: October 13, 2021
• Results First Posted: October 13, 2021

Record last verified: 2021-09

Locations

TW (1)