An interventional study of GiMer Medical MN 1000 External Stimulator in Pain, Chronic, Pain, Back and Pain, Radiating, sponsored by GiMer Medical. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-10-13.
Sponsored by GiMer Medical · Not applicable, Interventional, and Treatment
Among 23 studies in Chronic Pain with a site in Taiwan — 3 open to participants now, 4 under way, none of them phase 3. Chronic Pain · Taiwan.
Among the 23 studies in Chronic Pain with a site in Taiwan, this one is the 20th largest by enrollment of the 20 interventional ones that give a count, is the only one that started in 2018, is one of 14 with no phase, and was the 5th registered.
3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.
Browse Chronic Pain studies →3 of the 23 studies in Chronic Pain with a site in Taiwan are open now. Recruiting first, the newest first:
Shin Kong Wu Ho-Su Memorial Hospital · Sites in Taiwan
Ages 18–80
Taipei Medical University Hospital · Sites in Taiwan
Ages 20+
Taipei Medical University · Sites in Taiwan
Ages 45–80
A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →
Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.
This study: 20 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 3 · Phase 4 1
First in 2010; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 60 across 2,387 interventional studies indexed under Chronic Pain.
Median enrollment 67 across the 20 interventional studies, 42 across the 3 observational. Of the 12 that completed or were terminated, 3 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 23 have an industry lead sponsor. The 10 most frequent:
GiMer Medical is the lead sponsor of 4 studies on the registry; none are open to participants now.
GiMer Medical has 2 studies filed under Chronic Pain — fewer than ten, so there is no comparison to draw.
1 of the studies in Chronic Pain with a site in Taiwan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07800676Taipei Medical UniversityA+HA Premium Oral Hyaluronic Acid Drink Functional Evaluation Trial for Delaying Joint Pain | 2027-01-31 |
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Among the 23 studies in Chronic Pain with a site in Taiwan, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 14 days
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
Time frame: 14 days
The Brief Pain Inventory (BPI)
The change from baseline in functionality using the BPI evaluations
Time frame: 14 days
Incidence of Stimulation-induced Paresthesia
To determine the presence or absence of stimulation-induced paresthesia.
Time frame: 14 days
Pain Relief Medication Consumption
Amount of pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline
Time frame: 14 days
Oswestry Low Back Pain Disability Questionnaire (ODI)
The change from baseline in functionality using the ODI evaluations
Time frame: 14 days
| Milestone | Ultrahigh Frequency (500 KHz) Stimulation |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
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.
| score on a scale | Ultrahigh Frequency (500 KHz) Stimulation |
|---|---|
| Change in Visual Analog Score From Baseline to Day 14 | -5.1 ± 2.3 |
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
| events | Ultrahigh Frequency (500 KHz) Stimulation |
|---|---|
| Record Incidence of Adverse Events | 16 |
The change from baseline in functionality using the BPI evaluations
Results for this outcome have not been posted.
To determine the presence or absence of stimulation-induced paresthesia.
Results for this outcome have not been posted.
Amount of pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline
Results for this outcome have not been posted.
The change from baseline in functionality using the ODI evaluations
Results for this outcome have not been posted.
Collected over 14 days from baseline. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ultrahigh Frequency (500 KHz) Stimulation | 0/10 (0%) | 0/10 (0%) | 9/10 (90%) |
| Event | Ultrahigh Frequency (500 KHz) Stimulation |
|---|---|
| Incision site painInjury, poisoning and procedural complications | 7/10 |
| weaknessMusculoskeletal and connective tissue disorders | 3/10 |
| painMusculoskeletal and connective tissue disorders | 2/10 |
| headacheNervous system disorders | 1/10 |
| ConstipationGastrointestinal disorders | 1/10 |
| InsomniaPsychiatric disorders | 1/10 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 1/10 |
| Age, Continuous(years) | Ultrahigh Frequency (500 KHz) Stimulation |
|---|---|
| Mean | 43.5 (24.9 to 65.9) |
| Sex: Female, Male(Participants) | Ultrahigh Frequency (500 KHz) Stimulation |
|---|---|
| Female | 5 |
| Male | 5 |
| Race and Ethnicity Not Collected(Participants) | Ultrahigh Frequency (500 KHz) Stimulation |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in Oct 2018, 6 months.
Results were first posted in Oct 2021, 2 years 11 months after primary completion.
Of 83 industry-sponsored interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's 6 months is below that.
Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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GiMer Medical