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A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain

Primary Purpose

Failed Back Surgery Syndrome, Complex Regional Pain Syndrome (CRPS)

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 Failed Back Surgery Syndrome

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age ≧20 and ≦75
Have a symptom of complex regional pain syndrome (CRPS), failed back surgery syndrome (FBSS), lower limb pain with or without lower back pain with a diagnosis related to spinal lesion and 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 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 escalating or changing pain condition within the past 30 days as evidenced by Investigator examination.
Be on anticoagulant medication with 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.
Has previously failed spinal cord stimulation therapy.
Currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy.
Has pain only within a cervical or thoracic distribution.
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
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 Stimulation

Arm Description

Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.

Outcomes

Primary Outcome Measures

Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE)

Number of Participants with Adverse Events and Serious Adverse Events

Secondary Outcome Measures

Change in Pain Measured by Visual Analog Scale (VAS)

VAS: 0 (no pain) to 10 (max pain). Change in pain as a result of ultrahigh frequency DRG stimulation, as measured by VAS score compare to baseline VAS.

Incidence of Paresthesia

If patients feel tingling during stimulation?

Change in Pain Medication Consumption

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

Full Information

NCT ID

NCT03285113

First Posted

September 14, 2017

Last Updated

December 29, 2020

Sponsor

GiMer Medical

Collaborators

China Medical University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03285113

Brief Title

A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain

Official Title

A Single-arm, Open Label, Single Center Pilot Study to Confirm the Safety of Dorsal Root Ganglia (DRG) and Ultrahigh Frequency Spinal Cord Stimulator in Patients With Chronic Lower Limb Pain

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

March 3, 2017 (Actual)

Primary Completion Date

February 5, 2018 (Actual)

Study Completion Date

February 5, 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

This study is a prospective, single-arm, open label, single center pilot study to confirm the safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The actual trial length is 5 days. Pts will be given ultrahigh frequency pulse stimulation, and VAS will be obtained after 3-4 hours of each stimulation.

Detailed Description

This study is a prospective, single-arm, open label, single center pilot study to confirm the safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The actual trial length is 5 days. An initial eligibility screening within Day -14. Pt admitted to hospital on Day 1. The lead implantation is conducted on Day 2, and the 1st treatment starts after anesthesia recovery (Day 2 T1). If VAS >4 at 4 hours after the 1st treatment, the 2nd treatment will be conducted. VAS will be acquired 4 hours after the 2nd treatment. On Day 3, physical examination and vital signs will be collected. If VAS >4, the 3rd treatment will be provided. One hour after the 3rd treatment, the device will be removed and an X-ray will be taken. Three hours after the removal, VAS will be collected and then the patient will be discharged. VAS will be estimated by phone call on Day 4, and the patient will return to OPD for follow up examination on Day 5. The trial is completed on Day 5 visit.

6. Conditions and Keywords

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

Failed Back Surgery Syndrome, Complex Regional Pain Syndrome (CRPS)

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 Stimulation

Arm Type

Experimental

Arm Description

Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.

Intervention Type

Device

Intervention Name(s)

GiMer Medical MN 1000 External Stimulator

Intervention Description

Trial stimulator to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead around DRG, 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

Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE)

Description

Number of Participants with Adverse Events and Serious Adverse Events

Time Frame

5 days

Secondary Outcome Measure Information:

Title

Change in Pain Measured by Visual Analog Scale (VAS)

Description

VAS: 0 (no pain) to 10 (max pain). Change in pain as a result of ultrahigh frequency DRG stimulation, as measured by VAS score compare to baseline VAS.

Time Frame

4 days

Title

Incidence of Paresthesia

Description

If patients feel tingling during stimulation?

Time Frame

2 days

Title

Change in Pain Medication Consumption

Description

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

Time Frame

5 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 complex regional pain syndrome (CRPS), failed back surgery syndrome (FBSS), lower limb pain with or without lower back pain with a diagnosis related to spinal lesion and 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 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 escalating or changing pain condition within the past 30 days as evidenced by Investigator examination. Be on anticoagulant medication with 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. Has previously failed spinal cord stimulation therapy. Currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy. Has pain only within a cervical or thoracic distribution. 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 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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A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain

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