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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03285113
Recruitment Status : Completed
First Posted : September 15, 2017
Results First Posted : January 22, 2021
Last Update Posted : January 22, 2021
China Medical University Hospital
Information provided by (Responsible Party):
GiMer Medical

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.

Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Complex Regional Pain Syndrome (CRPS) Device: GiMer Medical MN 1000 External Stimulator Not Applicable

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.

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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 Pilot Study to Confirm the Safety of Dorsal Root Ganglia (DRG) and Ultrahigh Frequency Spinal Cord Stimulator in Patients With Chronic Lower Limb Pain
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : February 5, 2018
Actual Study Completion Date : February 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: Ultrahigh Frequency Stimulation
Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.
Device: GiMer Medical MN 1000 External Stimulator
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 Measures :
  1. Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE) [ Time Frame: 5 days ]
    Number of Participants with Adverse Events and Serious Adverse Events

Secondary Outcome Measures :
  1. Change in Pain Measured by Visual Analog Scale (VAS) [ Time Frame: 4 days ]
    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.

  2. Incidence of Paresthesia [ Time Frame: 2 days ]
    If patients feel tingling during stimulation?

  3. Change in Pain Medication Consumption [ Time Frame: 5 days ]
    Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age ≧20 and ≦75
  2. 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.
  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 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 escalating or changing pain condition within the past 30 days as evidenced by Investigator examination.
  3. 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).
  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.
  6. Has previously failed spinal cord stimulation therapy.
  7. 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.
  8. Has pain only within a cervical or thoracic distribution.
  9. Have a current diagnosis of cancer with active symptoms
  10. Have a known terminal illness with life expectancy less than one year
  11. Have a systematic or local infection
  12. Currently has an indwelling device that may pose an increased risk of infection.
  13. Be pregnant or breast feeding
  14. Have a medical history of drug or alcohol addiction within the past 2 years.
  15. Participation in any investigational study in the last 30 days or current enrollment in any trial.
  16. Be currently involved in an injury claim law suit or medically related litigation, including workers compensation.
  17. Be a prisoner.

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 identifier (NCT number): NCT03285113

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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  [PDF] February 13, 2017
No Statistical Analysis Plan (SAP) exists for this study.

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Responsible Party: GiMer Medical Identifier: NCT03285113    
Other Study ID Numbers: CTC1601
First Posted: September 15, 2017    Key Record Dates
Results First Posted: January 22, 2021
Last Update Posted: January 22, 2021
Last Verified: December 2020

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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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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Failed Back Surgery Syndrome
Pathologic Processes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Postoperative Complications
Back Pain
Neurologic Manifestations