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

• Sponsor: GiMer Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03285113
• Collaborator: China Medical University Hospital (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 11.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Failed Back Surgery Syndrome; Complex Regional Pain Syndrome (CRPS)	Device: GiMer Medical MN 1000 External Stimulator	N/A

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

• 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 Pilot Study to Confirm the Safety of Dorsal Root Ganglia (DRG) and Ultrahigh Frequency Spinal Cord Stimulator in Patients With Chronic Lower Limb Pain
• Actual Study Start Date: Mar 3, 2017
• Actual Primary Completion Date: Feb 5, 2018
• Actual Study Completion Date: Feb 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
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; 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.

Outcome Measures

Primary Outcome Measures

1. Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE) [5 days]

   Number of Participants with Adverse Events and Serious Adverse Events

Secondary Outcome Measures

1. Change in Pain Measured by Visual Analog Scale (VAS) [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.

2. Incidence of Paresthesia [2 days]

   If patients feel tingling during stimulation?

3. Change in Pain Medication Consumption [5 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: 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:

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.

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 - Feb 13, 2017

More Information

Publications

None provided.

• Responsible Party: GiMer Medical
• ClinicalTrials.gov Identifier: NCT03285113
• Other Study ID Numbers: CTC1601
• First Posted: Sep 15, 2017
• Last Update Posted: Jan 22, 2021
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Failed Back Surgery Syndrome

Study Results

Participant Flow

Arm/Group Title	Ultrahigh Frequency Stimulation
Arm/Group Description	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.
Period Title: Overall Study
STARTED	10
COMPLETED	8
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Ultrahigh Frequency Stimulation
Arm/Group Description	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 Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.5 (15.5)
Sex: Female, Male (Count of Participants)
Female	4 40%
Male	6 60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	10 100%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE)
Description	Number of Participants with Adverse Events and Serious Adverse Events
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrahigh Frequency Stimulation
Arm/Group Description	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.
Measure Participants	10
Count of Participants [Participants]	5 50%

2. Secondary Outcome

Title	Change in Pain Measured by Visual Analog Scale (VAS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrahigh Frequency Stimulation
Arm/Group Description	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.
Measure Participants	8
Mean (Standard Deviation) [units on a scale]	-2.7 (2.1)

3. Secondary Outcome

Title	Incidence of Paresthesia
Description	If patients feel tingling during stimulation?
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrahigh Frequency Stimulation
Arm/Group Description	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.
Measure Participants	8
Count of Participants [Participants]	0 0%

4. Secondary Outcome

Title	Change in Pain Medication Consumption
Description	Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrahigh Frequency Stimulation
Arm/Group Description	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.
Measure Participants	10
Count of Participants [Participants]	3 30%

Adverse Events

Time Frame	Trial duration (4 days)
Arm/Group Title	Ultrahigh Frequency Stimulation
Arm/Group Description	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.
All Cause Mortality
	Ultrahigh Frequency Stimulation
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Ultrahigh Frequency Stimulation
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Ultrahigh Frequency Stimulation
	Affected / at Risk (%)	# Events
Total	5/10 (50%)
Gastrointestinal disorders
Nausea	1/10 (10%)	1
Injury, poisoning and procedural complications
Incision site pain	3/10 (30%)	3
procedural headache	1/10 (10%)	1
Investigations
Increase blood pressure	1/10 (10%)	1
Nervous system disorders
Dizziness	1/10 (10%)	1
Skin and subcutaneous tissue disorders
Pruritus	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.