CClinicalTrials.gg
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

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
20 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Failed Back Surgery Syndrome
  • Complex Regional Pain Syndrome (CRPS)
03

Who can participate

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

Inclusion criteria

  1. Age ≧20 and ≦75
  2. 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.
  3. Have an average pain score >5 by Visual Analogue Scale (VAS) on inclusion.
  4. Has failed to achieve adequate pain relief from prior pharmacologic treatments.
  5. In the judgement of the investigator, the subject is an appropriate candidate for the trial procedure
  6. The subject is willing and able to comply with the procedure and requirements of this trial.
  7. The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by Investigator examination.
  3. 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).
  4. Has had corticosteroid therapy at an intended site of stimulation within the past 30 days.
  5. Pain medication(s) dosages(s) are not stable for at least 30 days.
  6. Has previously failed spinal cord stimulation therapy.
  7. 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.
  8. Has pain only within a cervical or thoracic distribution.
  9. Have a current diagnosis of cancer with active symptoms
  10. Have a known terminal illness with life expectancy less than one year
  11. Have a systematic or local infection
  12. Currently has an indwelling device that may pose an increased risk of infection.
  13. Be pregnant or breast feeding
  14. Have a medical history of drug or alcohol addiction within the past 2 years.
  15. Participation in any investigational study in the last 30 days or current enrollment in any trial.
  16. Be currently involved in an injury claim law suit or medically related litigation, including workers compensation.
  17. Be a prisoner.
04

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.

05

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. Incidence of Paresthesia

    If patients feel tingling during stimulation?

    Time frame: 2 days

  3. 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

06

Results

Posted Jan 22, 2021

Participant flow

Participant flow — Overall Study
MilestoneUltrahigh Frequency Stimulation
Started10
Completed8
Not completed2
Withdrew: Unable to implant leads2

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)
ParticipantsUltrahigh 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 scaleUltrahigh 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
ParticipantsUltrahigh Frequency Stimulation
Incidence of Paresthesia0
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
ParticipantsUltrahigh Frequency Stimulation
Change in Pain Medication Consumption3

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Ultrahigh Frequency Stimulation0/10 (0%)0/10 (0%)5/10 (50%)
Most frequent other events
Most frequent other events
EventUltrahigh Frequency Stimulation
Incision site painInjury, poisoning and procedural complications3/10
procedural headacheInjury, poisoning and procedural complications1/10
NauseaGastrointestinal disorders1/10
PruritusSkin and subcutaneous tissue disorders1/10
Increase blood pressureInvestigations1/10
DizzinessNervous system disorders1/10

Baseline characteristics

Age, Continuous
Age, Continuous(years)Ultrahigh Frequency Stimulation
Mean53.5 ± 15.5
Sex: Female, Male
Sex: Female, Male(Participants)Ultrahigh Frequency Stimulation
Female4
Male6
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Ultrahigh Frequency Stimulation
American Indian or Alaska Native0
Asian10
Native Hawaiian or Other Pacific Islander0
Black or African American0
White0
More than one race0
Unknown or Not Reported0
07

Study locations

1 site
  • China Medical University Hospital
    Taichung, Taiwan
08

References and documents

Study documents

  • Study protocol · Feb 13, 2017

Documents are hosted by the registry — open the source record to download them.

09

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 ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion