Trial Outcomes & Findings for A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain (NCT NCT03285113)

Results Overview

Number of Participants with Adverse Events and Serious Adverse Events

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

5 days

Results posted on

2021-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	Ultrahigh Frequency Stimulation Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. GiMer 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.
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Ultrahigh Frequency Stimulation Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. GiMer 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.
Overall Study Unable to implant leads	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrahigh Frequency Stimulation n=10 Participants Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. GiMer 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.
Age, Continuous	53.5 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Number of Participants with Adverse Events and Serious Adverse Events

Outcome measures

Outcome measures
Measure	Ultrahigh Frequency Stimulation n=10 Participants Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. GiMer 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.
Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE)	5 Participants

SECONDARY outcome

Timeframe: 4 days

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.

Outcome measures

Outcome measures
Measure	Ultrahigh Frequency Stimulation n=8 Participants Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. GiMer 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.
Change in Pain Measured by Visual Analog Scale (VAS)	-2.7 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 2 days

If patients feel tingling during stimulation?

Outcome measures

Outcome measures
Measure	Ultrahigh Frequency Stimulation n=8 Participants Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. GiMer 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.
Incidence of Paresthesia	0 Participants

SECONDARY outcome

Timeframe: 5 days

Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline

Outcome measures

Outcome measures
Measure	Ultrahigh Frequency Stimulation n=10 Participants Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. GiMer 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.
Change in Pain Medication Consumption	3 Participants

Adverse Events

Ultrahigh Frequency Stimulation

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ultrahigh Frequency Stimulation n=10 participants at risk Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. GiMer 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.
Injury, poisoning and procedural complications Incision site pain	30.0% 3/10 • Number of events 3 • Trial duration (4 days)
Injury, poisoning and procedural complications procedural headache	10.0% 1/10 • Number of events 1 • Trial duration (4 days)
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1 • Trial duration (4 days)
Skin and subcutaneous tissue disorders Pruritus	10.0% 1/10 • Number of events 1 • Trial duration (4 days)
Investigations Increase blood pressure	10.0% 1/10 • Number of events 1 • Trial duration (4 days)
Nervous system disorders Dizziness	10.0% 1/10 • Number of events 1 • Trial duration (4 days)

Additional Information

Dr. Yeong-Ray Wen (Department of Anaesthesia)

China Medical University Hospital (in Taiwan)

Phone: +886 4 2205-2121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place