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

Failed Back Surgery Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03285113
• Other study ID #: CTC1601
• Status: Completed
• Phase: N/A
• Start date: March 3, 2017
• Est. completion date: February 5, 2018

Study information

• Verified date: December 2020
• Source: GiMer Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 5, 2018
• Est. primary completion date: February 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome (CRPS)
• Complex Regional Pain Syndromes
• Failed Back Surgery Syndrome
• Reflex Sympathetic Dystrophy
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
GiMer Medical	China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE)	Number of Participants with Adverse Events and Serious Adverse Events	5 days
Secondary	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.	4 days
Secondary	Incidence of Paresthesia	If patients feel tingling during stimulation?	2 days
Secondary	Change in Pain Medication Consumption	Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline	5 days