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

NCT03285113 | Completed Results

• 1 other identifier: CTC1601
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Failed Back Surgery Syndrome; Complex Regional Pain Syndrome (CRPS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Pain Measured by Visual Analog Scale (VAS)

  4 days

• Incidence of Paresthesia

  2 days

• Change in Pain Medication Consumption

  5 days

Study Arms (1)

Ultrahigh Frequency Stimulation

EXPERIMENTAL

Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.

Device: GiMer Medical MN 1000 External Stimulator

Interventions

GiMer Medical MN 1000 External Stimulator DEVICE

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.

Ultrahigh Frequency Stimulation

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≧20 and ≦75
• 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.
• Has failed to achieve adequate pain relief from prior pharmacologic treatments.
• In the judgement of the investigator, the subject is an appropriate candidate for the trial procedure
• The subject is willing and able to comply with the procedure and requirements of this trial.
• The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.

You may not qualify if:

• 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.
• Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by Investigator examination.
• 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).
• Has had corticosteroid therapy at an intended site of stimulation within the past 30 days.
• Pain medication(s) dosages(s) are not stable for at least 30 days.
• Has previously failed spinal cord stimulation therapy.
• 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.
• Has pain only within a cervical or thoracic distribution.
• Have a current diagnosis of cancer with active symptoms
• Have a known terminal illness with life expectancy less than one year
• Have a systematic or local infection
• Currently has an indwelling device that may pose an increased risk of infection.
• Be pregnant or breast feeding
• Have a medical history of drug or alcohol addiction within the past 2 years.
• Participation in any investigational study in the last 30 days or current enrollment in any trial.

Sponsors & Collaborators

• GiMer Medical: lead
• China Medical University Hospital: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: Dr. Yeong-Ray Wen (Department of Anaesthesia)
• Organization: China Medical University Hospital (in Taiwan)

yray.wen@gmail.com

+886 4 2205-2121

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 15, 2017
• Study Start: March 3, 2017
• Primary Completion: February 5, 2018
• Study Completion: February 5, 2018
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2020-12

Locations

TW (1)