Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain

• Sponsor: GiMer Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03543085
• Collaborator: China Medical University Hospital (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.4
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Chronic; Pain, Back; Pain, Radiating	Device: GiMer Medical MN 1000 External Stimulator	N/A

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

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 12, 2018
• Actual Primary Completion Date: Oct 23, 2018
• Actual Study Completion Date: Oct 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Change in Visual Analog Score From Baseline to Day 14 [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.

2. Record Incidence of Adverse Events [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

Secondary Outcome Measures

1. The Brief Pain Inventory (BPI) [14 days]

   The change from baseline in functionality using the BPI evaluations

2. Incidence of Stimulation-induced Paresthesia [14 days]

   To determine the presence or absence of stimulation-induced paresthesia.

3. Pain Relief Medication Consumption [14 days]

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

4. Oswestry Low Back Pain Disability Questionnaire (ODI) [14 days]

   The change from baseline in functionality using the ODI evaluations

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≧20 and ≦75

2. 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.

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 Institutional Review Board (IRB) requirements.

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 unstable pain condition within the past 30 days as interviewed by Investigator.

3. 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).

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 at investigator's discretion.

6. 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.

7. Have a current diagnosis of cancer with active symptoms.

8. Have a known terminal illness with life expectancy less than one year.

9. Have a systematic or local infection, which may increase study risk.

10. Currently has an indwelling device that may pose an increased risk of infection.

11. Be pregnant or breast feeding.

12. Have a medical history of drug or alcohol addiction within the past 2 years.

13. Participation in any investigational study in the last 30 days or current enrollment in any trial.

14. Be currently involved in an injury claim law suit or medically related litigation, including workers compensation.

15. Be a prisoner.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China Medical University Hospital	Taichung		Taiwan

Sponsors and Collaborators

• GiMer Medical
• China Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 5, 2018

More Information

Publications

None provided.

• Responsible Party: GiMer Medical
• ClinicalTrials.gov Identifier: NCT03543085
• Other Study ID Numbers: PT1710001
• First Posted: Jun 1, 2018
• Last Update Posted: Oct 13, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Back Pain; Chronic Pain; Pain

Study Results

Participant Flow

Arm/Group Title	Ultrahigh Frequency (500 KHz) Stimulation
Arm/Group Description	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.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Ultrahigh Frequency (500 KHz) Stimulation
Arm/Group Description	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 Participants	10
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	43.5
Sex: Female, Male (Count of Participants)
Female	5 50%
Male	5 50%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Change in Visual Analog Score From Baseline to Day 14
Description	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.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrahigh Frequency (500 KHz) Stimulation
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Deviation) [score on a scale]	-5.1 (2.3)

2. Primary Outcome

Title	Record Incidence of Adverse Events
Description	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
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrahigh Frequency (500 KHz) Stimulation
Arm/Group Description	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.
Measure Participants	10
Number [events]	16

3. Secondary Outcome

Title	The Brief Pain Inventory (BPI)
Description	The change from baseline in functionality using the BPI evaluations
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Incidence of Stimulation-induced Paresthesia
Description	To determine the presence or absence of stimulation-induced paresthesia.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Pain Relief Medication Consumption
Description	Amount of pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Oswestry Low Back Pain Disability Questionnaire (ODI)
Description	The change from baseline in functionality using the ODI evaluations
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	14 days from baseline
Arm/Group Title	Ultrahigh Frequency (500 KHz) Stimulation
Arm/Group Description	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.
All Cause Mortality
	Ultrahigh Frequency (500 KHz) Stimulation
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Ultrahigh Frequency (500 KHz) Stimulation
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Ultrahigh Frequency (500 KHz) Stimulation
	Affected / at Risk (%)	# Events
Total	9/10 (90%)
Gastrointestinal disorders
Constipation	1/10 (10%)	1
Injury, poisoning and procedural complications
Incision site pain	7/10 (70%)	7
Musculoskeletal and connective tissue disorders
weakness	3/10 (30%)	3
pain	2/10 (20%)	2
Nervous system disorders
headache	1/10 (10%)	1
Psychiatric disorders
Insomnia	1/10 (10%)	1
Skin and subcutaneous tissue disorders
Dermatitis contact	1/10 (10%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.