Pain, ChronicNCT03543085
Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain
A study testing GiMer Medical MN 1000 External Stimulator in people with Pain, Chronic and Pain, Back, run by GiMer Medical at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pain, Chronic, Pain, Back, Pain, Radiating
- What is being tested?
- GiMer Medical MN 1000 External Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Apr 2018to 23 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≧20 and ≦75
- 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.
- 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 informed consent, and has signed their written informed consent in accordance with Institutional Review Board (IRB) requirements.
Who cannot join
- 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 unstable pain condition within the past 30 days as interviewed by Investigator.
- 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).
- Has had corticosteroid 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 at investigator's discretion.
- 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.
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- Have a current diagnosis of cancer with active symptoms.
- Have a known terminal illness with life expectancy less than one year.
- Have a systematic or local infection, which may increase study risk.
- 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 investigational 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Pain, Chronic, Pain, Back, Pain, Radiating
- Being tested
- GiMer Medical MN 1000 External Stimulator
- Medical subject headings
- Chronic Pain, Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GiMer Medical MN 1000 External StimulatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrahigh Frequency (500 KHz) Stimulation | Experimental | 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. Receives: Device: GiMer Medical MN 1000 External Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 14 days
Secondary outcomes (4)
The Brief Pain Inventory (BPI)
The change from baseline in functionality using the BPI evaluations
Measured: 14 days
Incidence of Stimulation-induced Paresthesia
To determine the presence or absence of stimulation-induced paresthesia.
Measured: 14 days
Pain Relief Medication Consumption
Amount of pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline
Measured: 14 days
Oswestry Low Back Pain Disability Questionnaire (ODI)
The change from baseline in functionality using the ODI evaluations
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start12 Apr 2018
- Primary completion23 Oct 2018
- Study completion23 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- GiMer Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- China Medical University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543085
- Sponsor's protocol ID
- PT1710001
- Status last verified
- Sep 2021
- First submitted
- 18 May 2018
- Last updated
- 13 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03543085
- Acronym / sponsor ID
- PT1710001
- Conditions
- Pain, Chronic, Pain, Back, Pain, Radiating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GiMer MedicalIndustry (pharma, biotech, devices)
- Collaborators
- China Medical University Hospital
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Posted 13 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrahigh Frequency (500 KHz) Stimulation | Experimental | Device: GiMer Medical MN 1000 External StimulatorThis 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≧20 and ≦75
- 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.
- 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.
Key exclusion criteria (15 listed)
- 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 unstable pain condition within the past 30 days as interviewed by Investigator.
- 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).
- Has had corticosteroid 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 at investigator's discretion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GiMer Medical MN 1000 External StimulatorTrial 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. | Device | Ultrahigh Frequency (500 KHz) Stimulation |
Primary outcome
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.
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
4 secondary outcomes
The Brief Pain Inventory (BPI)
Time frame: 14 days
Incidence of Stimulation-induced Paresthesia
Time frame: 14 days
Pain Relief Medication Consumption
Time frame: 14 days
Oswestry Low Back Pain Disability Questionnaire (ODI)
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GiMer Medical MN 1000 External Stimulator in people with Pain, Chronic and Pain, Back, run by GiMer Medical at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Score From Baseline to Day 14 (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.