An interventional study of GiMer Medical MN 1000 External Stimulator in Failed Back Surgery Syndrome and Complex Regional Pain Syndrome (CRPS), sponsored by GiMer Medical. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by GiMer Medical · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE)
Number of Participants with Adverse Events and Serious Adverse Events
Time frame: 5 days
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.
Time frame: 4 days
Incidence of Paresthesia
If patients feel tingling during stimulation?
Time frame: 2 days
Change in Pain Medication Consumption
Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline
Time frame: 5 days
| Milestone | Ultrahigh Frequency Stimulation |
|---|---|
| Started | 10 |
| Completed | 8 |
| Not completed | 2 |
| Withdrew: Unable to implant leads | 2 |
Number of Participants with Adverse Events and Serious Adverse Events
| Participants | Ultrahigh Frequency Stimulation |
|---|---|
| Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE) | 5 |
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.
| units on a scale | Ultrahigh Frequency Stimulation |
|---|---|
| Change in Pain Measured by Visual Analog Scale (VAS) | -2.7 ± 2.1 |
If patients feel tingling during stimulation?
| Participants | Ultrahigh Frequency Stimulation |
|---|---|
| Incidence of Paresthesia | 0 |
Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline
| Participants | Ultrahigh Frequency Stimulation |
|---|---|
| Change in Pain Medication Consumption | 3 |
Collected over Trial duration (4 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ultrahigh Frequency Stimulation | 0/10 (0%) | 0/10 (0%) | 5/10 (50%) |
| Event | Ultrahigh Frequency Stimulation |
|---|---|
| Incision site painInjury, poisoning and procedural complications | 3/10 |
| procedural headacheInjury, poisoning and procedural complications | 1/10 |
| NauseaGastrointestinal disorders | 1/10 |
| PruritusSkin and subcutaneous tissue disorders | 1/10 |
| Increase blood pressureInvestigations | 1/10 |
| DizzinessNervous system disorders | 1/10 |
| Age, Continuous(years) | Ultrahigh Frequency Stimulation |
|---|---|
| Mean | 53.5 ± 15.5 |
| Sex: Female, Male(Participants) | Ultrahigh Frequency Stimulation |
|---|---|
| Female | 4 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | Ultrahigh Frequency Stimulation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 10 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Complex Regional Pain Syndromes→
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