Trial Outcomes & Findings for Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain (NCT NCT03543085)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

14 days

Results posted on

2021-10-13

Participant Flow

Participant milestones

Participant milestones
Measure	Ultrahigh Frequency (500 KHz) Stimulation 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. GiMer Medical MN 1000 External Stimulator: 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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrahigh Frequency (500 KHz) Stimulation n=10 Participants 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. GiMer Medical MN 1000 External Stimulator: 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.
Age, Continuous	43.5 years n=10 Participants
Sex: Female, Male Female	5 Participants n=10 Participants
Sex: Female, Male Male	5 Participants n=10 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ultrahigh Frequency (500 KHz) Stimulation n=10 Participants 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. GiMer Medical MN 1000 External Stimulator: 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.
Change in Visual Analog Score From Baseline to Day 14	-5.1 score on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Ultrahigh Frequency (500 KHz) Stimulation n=10 Participants 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. GiMer Medical MN 1000 External Stimulator: 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.
Record Incidence of Adverse Events	16 events

SECONDARY outcome

Timeframe: 14 days

Other adverse events

Other adverse events
Measure	Ultrahigh Frequency (500 KHz) Stimulation n=10 participants at risk 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. GiMer Medical MN 1000 External Stimulator: 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.
Injury, poisoning and procedural complications Incision site pain	70.0% 7/10 • Number of events 7 • 14 days from baseline
Nervous system disorders headache	10.0% 1/10 • Number of events 1 • 14 days from baseline
Gastrointestinal disorders Constipation	10.0% 1/10 • Number of events 1 • 14 days from baseline
Musculoskeletal and connective tissue disorders weakness	30.0% 3/10 • Number of events 3 • 14 days from baseline
Musculoskeletal and connective tissue disorders pain	20.0% 2/10 • Number of events 2 • 14 days from baseline
Psychiatric disorders Insomnia	10.0% 1/10 • Number of events 1 • 14 days from baseline
Skin and subcutaneous tissue disorders Dermatitis contact	10.0% 1/10 • Number of events 1 • 14 days from baseline

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