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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03285113
Recruitment Status : Completed
First Posted : September 15, 2017
Results First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
China Medical University Hospital
Information provided by (Responsible Party):
GiMer Medical

Tracking Information
First Submitted Date  ICMJE September 14, 2017
First Posted Date  ICMJE September 15, 2017
Results First Submitted Date  ICMJE June 5, 2020
Results First Posted Date  ICMJE January 22, 2021
Last Update Posted Date January 22, 2021
Actual Study Start Date  ICMJE March 3, 2017
Actual Primary Completion Date February 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2020)
Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE) [ Time Frame: 5 days ]
Number of Participants with Adverse Events and Serious Adverse Events
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
Safety of ultrahigh frequency treatment: Adverse event (AE) and serious AE (SAE) incidence rates during the trial [ Time Frame: 5 days ]
Adverse event (AE) and serious AE (SAE) incidence rates during the trial
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2020)
  • Change in Pain Measured by Visual Analog Scale (VAS) [ Time Frame: 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.
  • Incidence of Paresthesia [ Time Frame: 2 days ]
    If patients feel tingling during stimulation?
  • Change in Pain Medication Consumption [ Time Frame: 5 days ]
    Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • Change in pain reduction measured by VAS score [ Time Frame: 4 days ]
    Change in pain reduction as a result of ultrahigh frequency DRG stimulation, as measured by VAS score compare to baseline.
  • Incidence of Paresthesia [ Time Frame: 2 days ]
    If patients feel tingling during stimulation?
  • Change in pain medication consumption [ Time Frame: 5 days ]
    Change in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Failed Back Surgery Syndrome
  • Complex Regional Pain Syndrome (CRPS)
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Ultrahigh Frequency Stimulation
Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.
Intervention: Device: GiMer Medical MN 1000 External Stimulator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 5, 2018
Actual Primary Completion Date February 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03285113
Other Study ID Numbers  ICMJE CTC1601
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GiMer Medical
Study Sponsor  ICMJE GiMer Medical
Collaborators  ICMJE China Medical University Hospital
Investigators  ICMJE Not Provided
PRS Account GiMer Medical
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP