Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06229470
Other study ID # D103977
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 8, 2024
Est. completion date February 28, 2027

Study information

Verified date May 2024
Source Saluda Medical Pty Ltd
Contact Angela Leitner, MS
Phone 651-208-4223
Email angela.leitner@saludamedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date February 28, 2027
Est. primary completion date February 28, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject is planning to have a temporary trial with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and/or intractable low back pain and leg pain. - Leg pain score = 6 cm (Visual Analog Scale [VAS]). - Back pain score = 6 cm (VAS). - Subject is able to speak, read, and/or understand English, willing and capable of giving informed consent, and able to comply with study-related requirements, procedures, and visits. - Subject is not pregnant and not <18 years of age. Exclusion Criteria: - N/A

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Evoke Spinal Cord Stimulation (SCS) System
A spinal cord stimulation (SCS) system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.

Locations

Country Name City State
United States Spanish Hills Interventional Pain Specialists Camarillo California
United States Goodman Campbell Brain and Spine Carmel Indiana
United States Garden State Pain and Orthopedics Clifton New Jersey
United States Pohlman Pain Associates Delray Beach Florida
United States Metro Anesthesia & Pain Management Des Moines Iowa
United States Spine and Joint Institute Glen Burnie Maryland
United States Tricity Research Center, LLC Grand Island Nebraska
United States Carolinas Center for Advanced Management of Pain Greenville South Carolina
United States Advanced Pain Institute Hammond Louisiana
United States Horizon Clinical Research Jasper Georgia
United States Pain Consultants of San Diego La Mesa California
United States Lakeside Spine and Pain Lake Havasu City Arizona
United States Restorative Pain Institute Louisville Kentucky
United States Premier Pain Treatment Institute Loveland Ohio
United States Reno Tahoe Pain Associates Reno Nevada
United States Pain Clinic of Michigan Rochester Hills Michigan
United States Rockford Pain Center Rockford Illinois
United States Pacific Research Institute Santa Rosa California
United States Precision Spine Care Tyler Texas
United States Victoria Pain and Rehabilitation Center Victoria Texas
United States Boomerang Healthcare Walnut Creek California
United States Seaside Clinical Research Institute Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Saluda Medical Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System physiological parameter to be measured = Evoked Compound Action Potentials (ECAPs); measurement tool = Evoke SCS System through 6-months post-implant
Secondary Change in Visual Analogue Scale (VAS) Pain Visual Analogue Scale (VAS) to rate pain intensity (0mm [no pain] to 100mm [worst pain imaginable]) through 6-months post-implant
Secondary Change in PROMIS-29+2 PROMIS-29 Profile and 2 PROMIS Cognitive Function Abilities items. The PROMIS-29 is a 29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity. through 6-months post-implant
Secondary Change in PROMIS-10 Global Health 10-item instrument that assesses Physical Health and Mental Health through 6-months post-implant
See also
  Status Clinical Trial Phase
Completed NCT01659073 - Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation N/A
Recruiting NCT05914311 - Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration N/A
Recruiting NCT05422456 - The Turkish Version of Functional Disability Inventory
Enrolling by invitation NCT05422443 - The Turkish Version of Pain Coping Questionnaire
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04385030 - Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury N/A
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05103319 - Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
Completed NCT03687762 - Back on Track to Healthy Living Study N/A
Completed NCT04171336 - Animal-assisted Therapy for Children and Adolescents With Chronic Pain N/A
Completed NCT03179475 - Targin® for Chronic Pain Management in Patients With Spinal Cord Injury Phase 4
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Recruiting NCT06060028 - The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain N/A
Recruiting NCT06204627 - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Terminated NCT03538444 - Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder N/A
Not yet recruiting NCT05812703 - Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain