- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03543085
Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain
September 16, 2021 updated by: GiMer Medical
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taichung, Taiwan
- China Medical University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≧20 and ≦75
- 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.
- Have an average pain score >5 by Visual Analogue Scale (VAS) on inclusion.
- 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 Institutional Review Board (IRB) requirements.
Exclusion Criteria:
- 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 unstable pain condition within the past 30 days as interviewed by Investigator.
- 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).
- 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 at investigator's discretion.
- 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.
- 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, which may increase study risk.
- 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.
- Be currently involved in an injury claim law suit or medically related litigation, including workers compensation.
- Be a prisoner.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Visual Analog Score From Baseline to Day 14
Time Frame: 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.
|
14 days
|
Record Incidence of Adverse Events
Time Frame: 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
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Brief Pain Inventory (BPI)
Time Frame: 14 days
|
The change from baseline in functionality using the BPI evaluations
|
14 days
|
Incidence of Stimulation-induced Paresthesia
Time Frame: 14 days
|
To determine the presence or absence of stimulation-induced paresthesia.
|
14 days
|
Pain Relief Medication Consumption
Time Frame: 14 days
|
Amount of pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline
|
14 days
|
Oswestry Low Back Pain Disability Questionnaire (ODI)
Time Frame: 14 days
|
The change from baseline in functionality using the ODI evaluations
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2018
Primary Completion (Actual)
October 23, 2018
Study Completion (Actual)
October 23, 2018
Study Registration Dates
First Submitted
May 18, 2018
First Submitted That Met QC Criteria
May 18, 2018
First Posted (Actual)
June 1, 2018
Study Record Updates
Last Update Posted (Actual)
October 13, 2021
Last Update Submitted That Met QC Criteria
September 16, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT1710001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain, Radiating
-
Jaseng Medical FoundationRecruitingRadiating Pain in the Upper ExtremityKorea, Republic of
-
OrthoCarolina Research Institute, Inc.Charlotte Surgery Center an affiate of SCASuspendedPain, RadiatingUnited States
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedCervical Pain | Neuropathic Pain | Radiating PainJapan
-
Karolinska University HospitalLinkoeping UniversityCompletedCervical Pain | Pain, RadiatingSweden
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
Marmara UniversityCompletedPain, Radiating | Cervical Radiculopathy | Pain, NeckTurkey
-
The Cleveland ClinicCompletedLow Back Pain | Radiating PainUnited States
-
KM Clinical Research GroupTerminatedPain, Radiating | Pain, Chronic | Pain Syndrome | Pain, BackUnited States
-
Jaseng Medical FoundationRecruitingSciatica | Paresthesia | Radiating Pain | DysesthesiaKorea, Republic of
-
Texas Back InstituteOrthofix Inc.; Innovative Spinal Technologies, Inc.CompletedRadiating Leg Pain | Disc ProtrusionUnited States
Clinical Trials on GiMer Medical MN 1000 External Stimulator
-
GiMer MedicalChina Medical University HospitalCompletedFailed Back Surgery Syndrome | Complex Regional Pain Syndrome (CRPS)Taiwan