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

Primary Purpose

Pain, Chronic, Pain, Back, Pain, Radiating

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

GiMer Medical MN 1000 External Stimulator

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Have an average pain score >5 by Visual Analogue Scale (VAS) on inclusion.
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.

Exclusion Criteria:

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.

Sites / Locations

China Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrahigh Frequency (500 KHz) Stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

The Brief Pain Inventory (BPI)

The change from baseline in functionality using the BPI evaluations

Incidence of Stimulation-induced Paresthesia

To determine the presence or absence of stimulation-induced paresthesia.

Pain Relief Medication Consumption

Amount of pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline

Oswestry Low Back Pain Disability Questionnaire (ODI)

The change from baseline in functionality using the ODI evaluations

Full Information

NCT ID

NCT03543085

First Posted

May 18, 2018

Last Updated

September 16, 2021

Sponsor

GiMer Medical

Collaborators

China Medical University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03543085

Brief Title

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

Official Title

A Single-arm, Open Label, Single Center, Prospective Study of Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

April 12, 2018 (Actual)

Primary Completion Date

October 23, 2018 (Actual)

Study Completion Date

October 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GiMer Medical

Collaborators

China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Detailed Description

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. The trial length is 14 days. Patients will be given ultrahigh frequency pulse stimulation, up to 3 times in every 24 hours, and VAS will be obtained at least once a day. Compared to previous study conducted last year, patient can now have two lead implant sites for different pain locations. The electrode implantation site will be epidural space instead of Dorsal Root Ganglion (DRG).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Chronic, Pain, Back, Pain, Radiating

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrahigh Frequency (500 KHz) Stimulation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

GiMer Medical MN 1000 External Stimulator

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Visual Analog Score From Baseline to Day 14

Description

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.

Time Frame

14 days

Title

Record Incidence of Adverse Events

Description

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

Time Frame

14 days

Secondary Outcome Measure Information:

Title

The Brief Pain Inventory (BPI)

Description

The change from baseline in functionality using the BPI evaluations

Time Frame

14 days

Title

Incidence of Stimulation-induced Paresthesia

Description

To determine the presence or absence of stimulation-induced paresthesia.

Time Frame

14 days

Title

Pain Relief Medication Consumption

Description

Amount of pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline

Time Frame

14 days

Title

Oswestry Low Back Pain Disability Questionnaire (ODI)

Description

The change from baseline in functionality using the ODI evaluations

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Have an average pain score >5 by Visual Analogue Scale (VAS) on inclusion. 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

China Medical University Hospital

City

Taichung

Country

Taiwan

12. IPD Sharing Statement

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

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