CompletedNCT03285113Updated Jan 22, 2021Results posted

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

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

From the registry’s dates

Registered 6 months after the study started (first participant enrolled Mar 2017, registered Sep 2017).

Phase: Not applicable
Study type: Interventional
Enrollment: 10
Allocation: Not applicable
Ages: 20 Years to 75 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Failed Back Surgery Syndrome
Complex Regional Pain Syndrome (CRPS)

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In context

Failed Back Surgery Syndrome

104 studies on the registry are indexed under Failed Back Surgery Syndrome; 17 are open to participants now.

This study's enrollment of 10 is below the median of 40 across 75 interventional studies indexed under Failed Back Surgery Syndrome.

Browse Failed Back Surgery Syndrome studies →

Lead sponsor

GiMer Medical is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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.

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 , and has signed their written informed consent in accordance with IRB requirements.

Exclusion criteria

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 >1.5 or count less than 100,000/μL, peripheral vascular diseases (PVDs), visceral pain or uncontrolled Diabetes mellitus (DM).
Has had 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 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 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.

Terms in these criteria, in plain language(6)

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.

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.

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.

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.

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.

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.

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 10 participants (actual)

Study arms

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

Interventions

DeviceGiMer 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.

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Results

Posted Jan 22, 2021

Participant flow

Participant flow — Overall Study
Milestone	Ultrahigh Frequency Stimulation
Started	10
Completed	8
Not completed	2
Withdrew: Unable to implant leads	2

Outcome measures

PrimarySafety 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
Reported as:: Count of participants · Participants

Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE)
Participants	Ultrahigh Frequency Stimulation
Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE)	5

SecondaryChange 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
Reported as:: Mean · units on a scale

Change in Pain Measured by Visual Analog Scale (VAS)
units on a scale	Ultrahigh Frequency Stimulation
Change in Pain Measured by Visual Analog Scale (VAS)	-2.7 ± 2.1

SecondaryIncidence of Paresthesia

If patients feel tingling during stimulation?

Time frame:: 2 days
Reported as:: Count of participants · Participants

Incidence of Paresthesia
Participants	Ultrahigh Frequency Stimulation
Incidence of Paresthesia	0

SecondaryChange 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
Reported as:: Count of participants · Participants

Change in Pain Medication Consumption
Participants	Ultrahigh Frequency Stimulation
Change in Pain Medication Consumption	3

Adverse events

Collected over Trial duration (4 days). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ultrahigh Frequency Stimulation	0/10 (0%)	0/10 (0%)	5/10 (50%)

Most frequent other events

Most frequent other events
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

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Ultrahigh Frequency Stimulation
Mean	53.5 ± 15.5

Sex: Female, Male
Sex: Female, Male(Participants)	Ultrahigh Frequency Stimulation
Female	4
Male	6

Race (NIH/OMB)
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

Study locations

1 site

China Medical University Hospital
Taichung, Taiwan

References and documents

Study documents

Study protocol ↗ · Feb 13, 2017

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2017 to primary completion in Feb 2018, 11 months.

Results were first posted in Jan 2021, 2 years 11 months after primary completion.

Of 38 interventional studies with no phase under Failed Back Surgery Syndrome, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 14, 2017
First posted: Sep 15, 2017
StartActual: Mar 3, 2017
Primary completionActual: Feb 5, 2018
CompletionActual: Feb 5, 2018
Results first posted: Jan 22, 2021
Last update: Jan 22, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03285113
Lead sponsor: GiMer Medical
Collaborators: China Medical University Hospital
Responsible party: Sponsor
First posted: Sep 15, 2017
Start date: Mar 3, 2017
Primary completion: Feb 5, 2018
Completion: Feb 5, 2018
Results posted: Jan 22, 2021
Last update: Jan 22, 2021

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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