Clinical Trials Logo
  1. Home
  2. Chronic Pain
  3. NCT04662905
  4. Details
NCT04662905 Clinical Trial

Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain

Chronic Pain Clinical Trial

— Freshwater  

Official title:
A Prospective, Multicentre, Single-arm Feasibility Study Examining Novel Treatment Delivery of the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04662905
Other study ID # CLIN-PCL-007873
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2020
Est. completion date January 1, 2027

Study information
Verified date December 2023
Source Saluda Medical Pty Ltd
Contact Director, Clinical Affairs
Phone 16512084223
Email angela.leitner@saludamedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled closed loop SCS through the incorporation of new software and/or hardware features for patients with the Evoke System.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date January 1, 2027
Est. primary completion date January 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 1. Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication. - 2. Subject is willing and capable of giving informed consent and able to comply with study-related requirements. Exclusion Criteria: N/A

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Evoke Spinal Cord Stimulation (SCS) System
ECAP-controlled, closed-loop SCS

Locations
Country Name City State
Australia Interventus Pain Specialists Auchenflower Queensland
Australia Sydney Pain Specialists Bella Vista New South Wales
Australia Axxon Pain Medicine Brisbane Queensland
Australia Genesis Research Services Broadmeadow New South Wales
Australia Northern Integrated Pain Management Charlestown New South Wales
Australia Monash Clinical Research Clayton Victoria
Australia PainCare Perth Cottesloe Western Australia
Australia QPAIN Fortitude Valley Queensland
Australia Frankston Pain Management Frankston Victoria
Australia ACT Pain Centre Garran Australian Capital Territory
Australia Pain Matrix Geelong Victoria
Australia Australian Medical Research Hurstville New South Wales
Australia Inner West Pain Centre Newtown New South Wales
Australia Sunshine Coast Clinical Research Noosa Heads Queensland
Australia Paul Frank Medical Services Peregian Beach Queensland
Australia Melbourne Pain Specialists Richmond Victoria
Australia Pain Specialists Australia Richmond Victoria
Australia Royal North Shore Hospital Saint Leonards New South Wales
Australia Northern Pain Centre St Leonards New South Wales
Australia Women's Health & Research Institute of Australia Sydney New South Wales
Australia Sydney Pain Research Centre Pty Ltd Wahroonga New South Wales
Australia CerCare Pty Ltd Wayville South Australia

Sponsors (1)
Lead Sponsor Collaborator
Saluda Medical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System Through study completion, up to 2 years
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