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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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ClinicalTrials.gov Identifier: NCT03543085
Recruitment Status : Completed
First Posted : June 1, 2018
Results First Posted : October 13, 2021
Last Update Posted : October 13, 2021
Sponsor:
Collaborator:
China Medical University Hospital
Information provided by (Responsible Party):
GiMer Medical

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain, Chronic Pain, Back Pain, Radiating Device: GiMer Medical MN 1000 External Stimulator Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 12, 2018
Actual Primary Completion Date : October 23, 2018
Actual Study Completion Date : October 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ultrahigh Frequency (500 KHz) Stimulation
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Visual Analog Score From Baseline to Day 14 [ Time Frame: 14 days ]
    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.

  2. Record Incidence of Adverse Events [ Time Frame: 14 days ]
    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 :
  1. The Brief Pain Inventory (BPI) [ Time Frame: 14 days ]
    The change from baseline in functionality using the BPI evaluations

  2. Incidence of Stimulation-induced Paresthesia [ Time Frame: 14 days ]
    To determine the presence or absence of stimulation-induced paresthesia.

  3. Pain Relief Medication Consumption [ Time Frame: 14 days ]
    Amount of pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline

  4. Oswestry Low Back Pain Disability Questionnaire (ODI) [ Time Frame: 14 days ]
    The change from baseline in functionality using the ODI evaluations


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≧20 and ≦75
  2. 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.
  3. Have an average pain score >5 by Visual Analogue Scale (VAS) on inclusion.
  4. Has failed to achieve adequate pain relief from prior pharmacologic treatments.
  5. In the judgement of the investigator, the subject is an appropriate candidate for the trial procedure.
  6. The subject is willing and able to comply with the procedure and requirements of this trial.
  7. 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:

  1. 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.
  2. Subject has exhibited unstable pain condition within the past 30 days as interviewed by Investigator.
  3. 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).
  4. Has had corticosteroid therapy at an intended site of stimulation within the past 30 days.
  5. Pain medication(s) dosages(s) are not stable for at least 30 days at investigator's discretion.
  6. 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.
  7. Have a current diagnosis of cancer with active symptoms.
  8. Have a known terminal illness with life expectancy less than one year.
  9. Have a systematic or local infection, which may increase study risk.
  10. Currently has an indwelling device that may pose an increased risk of infection.
  11. Be pregnant or breast feeding.
  12. Have a medical history of drug or alcohol addiction within the past 2 years.
  13. Participation in any investigational study in the last 30 days or current enrollment in any trial.
  14. Be currently involved in an injury claim law suit or medically related litigation, including workers compensation.
  15. Be a prisoner.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543085


Locations
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Taiwan
China Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
GiMer Medical
China Medical University Hospital
  Study Documents (Full-Text)

Documents provided by GiMer Medical:
Study Protocol and Statistical Analysis Plan  [PDF] January 5, 2018

More Information
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Responsible Party: GiMer Medical
ClinicalTrials.gov Identifier: NCT03543085    
Other Study ID Numbers: PT1710001
First Posted: June 1, 2018    Key Record Dates
Results First Posted: October 13, 2021
Last Update Posted: October 13, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Chronic Pain
Pain
Neurologic Manifestations