Failed Back Surgery SyndromeNCT03285113
A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain
A study testing GiMer Medical MN 1000 External Stimulator in people with Failed Back Surgery Syndrome and Complex Regional Pain Syndrome (CRPS), run by GiMer Medical at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Failed Back Surgery Syndrome, Complex Regional Pain Syndrome (CRPS)
- 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
- 3 Mar 2017to 5 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 informed consent, and has signed their written informed consent in accordance with 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 escalating or changing pain condition within the past 30 days as evidenced by Investigator examination.
- 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).
- 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.
- Has previously failed spinal cord stimulation therapy.
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- 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 life expectancy 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 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 Pilot Study to Confirm the Safety of Dorsal Root Ganglia (DRG) and Ultrahigh Frequency Spinal Cord Stimulator in Patients With Chronic Lower Limb Pain
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.
- Being tested
- GiMer Medical MN 1000 External Stimulator
- Medical subject headings
- Failed Back Surgery Syndrome, Complex Regional Pain Syndromes
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrahigh Frequency Stimulation | Experimental | Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. 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.
Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE)
Number of Participants with Adverse Events and Serious Adverse Events
Measured: 5 days
Secondary outcomes (3)
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.
Measured: 4 days
Incidence of Paresthesia
If patients feel tingling during stimulation?
Measured: 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
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start3 Mar 2017
- Primary completion5 Feb 2018
- Study completion5 Feb 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 Failed Back Surgery SyndromeStudies 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
- NCT03285113
- Sponsor's protocol ID
- CTC1601
- Status last verified
- Dec 2020
- First submitted
- 14 Sep 2017
- Last updated
- 22 Jan 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 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03285113
- Acronym / sponsor ID
- CTC1601
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GiMer MedicalIndustry (pharma, biotech, devices)
- Collaborators
- China Medical University Hospital
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Posted 22 Jan 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 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.
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.
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 Stimulation | Experimental | Device: GiMer Medical MN 1000 External StimulatorPatients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 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 escalating or changing pain condition within the past 30 days as evidenced by Investigator examination.
- 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).
- 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.
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 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. | Device | Ultrahigh Frequency Stimulation |
Primary outcome
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
3 secondary outcomes
Change in Pain Measured by Visual Analog Scale (VAS)
Time frame: 4 days
Incidence of Paresthesia
Time frame: 2 days
Change in Pain Medication Consumption
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 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 Failed Back Surgery Syndrome and Complex Regional Pain Syndrome (CRPS), 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 17 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 22 Jan 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 22 Jan 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?
Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE) (time frame: 5 days). 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 22 Jan 2021.