Clinical Trial of MED HF10™ Spinal Cord Stimulation for the Treatment of Chronic Pain
NCT06897280 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-03-26
Summary
This is a single-center, prospective, non-randomized exploratory study in subjects with chronic, intractable back pain and/or leg pain per the center's routine practice. The primary endpoint is the distribution of responders by 'lowest preferred pulse dose (PD)' setting, where a subject is a responder to the lowest PD setting they preferred prior to entering the Observational period. The study is performed in patients who already have Nevro SCS devices implanted.
Conditions
- Chronic, Intractable Back Pain And/or Leg Pain
Interventions
- DEVICE
-
SCS Device Program Setting
A Pulse Dose setting specifies a brief duration of stimulation 'on' and stimulation 'off' durations, applied in a continuously cycled manner
Sponsors & Collaborators
-
Nevro Corp
lead INDUSTRY
Principal Investigators
-
Mayank Gupta, MD · Neuroscience Research Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-16
- Primary Completion
- 2024-11-16
- Completion
- 2026-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study
NCT06121232 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Lumbar Injectrode Feasibility Evaluation
NCT06206356 ·Status: COMPLETED ·Phase: PHASE1
-
BurstDR™ micrOdosing stimuLation in De-novo Patients
NCT03350256 ·Status: COMPLETED ·Phase: NA
-
Mechanisms of Stimulation for Pain Alleviation
NCT06741579 ·Status: RECRUITING ·Phase: PHASE3
-
Effect of Spinal Cord Stimulation (SCS) on Insulin Secretion in Humans
NCT05794776 ·Status: WITHDRAWN ·Phase: NA
-
Burst Spinal Cord Stimulation for Neuropathic Pain.
NCT03733886 ·Status: COMPLETED ·Phase: NA
-
Medtronic Inceptiv™ Closed-Loop DTM Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy
NCT07209514 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Burst Optimized Stimulation Study
NCT02896361 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy
NCT07250828 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
A Clinical Trial to Investigate Efficacy and Safety of NT 201 Injections Compared With Placebo Injections in Participants Aged 18 Years and Older With Chronic Nerve Pain After Shingles or Nerve Injury
NCT06091020 ·Status: COMPLETED ·Phase: PHASE2
-
A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain
NCT05630196 ·Status: COMPLETED ·Phase: PHASE2
-
(2R,6R)-Hydroxynorketamine for the Treatment of Neuropathic Pain
NCT05864053 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Stimgenics Open-Label, Post Market Study
NCT03606187 ·Status: COMPLETED ·Phase: NA
-
Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain
NCT02729480 ·Status: COMPLETED ·Phase: NA
-
Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy
NCT04678895 ·Status: RECRUITING ·Phase: PHASE2
-
Compounded Pain Creams and Patient Perception
NCT02024802 ·Status: WITHDRAWN
-
Clinical Study of a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain (COMFORT 2)
NCT05870124 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain
NCT03658018 ·Status: WITHDRAWN ·Phase: NA
-
Long-term Effect of Motor Cortex Stimulation in Patients Suffering From Chronic Neuropathic Pain
NCT03189823 ·Status: COMPLETED
-
Validation of Pre-clinical Nano-Based Analgesics in Cells From Human Dorsal Root Ganglia
NCT04533919 ·Status: WITHDRAWN
-
Retrospective PNS Study
NCT06832449 ·Status: ACTIVE_NOT_RECRUITING
-
A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05).
NCT05620576 ·Status: COMPLETED ·Phase: PHASE2
-
Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy
NCT01564069 ·Status: COMPLETED
-
Evaluate the Safety and Efficacy of a Peripheral Nerve Stimulation
NCT05827848 ·Status: RECRUITING ·Phase: NA
-
Comparative Study in Patients With Refractory Chronic Lower Limb Neuropathic Pain and/or Back Neuropathic Pain.
NCT04852107 ·Status: TERMINATED ·Phase: NA