Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359561
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-11
First Post:
2024-02-27
Brief Title:
Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord Stimulation CL-SCS Therapy in Patients With Cervical Lead Placement
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational prospective data collection is designed to evaluate the effectiveness and stimulation coverage of closed-loop spinal cord stimulation CL-SCS therapy in patients with cervical lead placement
Detailed Description:
Title Assessment of effectiveness and stimulation coverage of closed-loop spinal cord stimulation CL-SCS therapy in patients with cervical lead placement
Device used in the study The Saluda Medical EvokeTM Closed-Loop Spinal Cord Stimulator CL-SCS System Evoke System The CE marked Evoke System will be used within its licensed use and manuals The Evoke System measures and records spinal cord SC activation resulting from stimulation via evoked compound action potentials ECAPs The Evoke System can be programmed to provide ECAP-controlled closed-loop SCS or open-loop fixed-output traditional SCS ECAPs may be measured and recorded in either stimulation mode
Indication for use The Evoke SCS System is indicated as an aid in the management of chronic intractable pain of the trunk andor limbs and will be used within its licensed indication during this study
Rational This observational prospective data collection is designed to evaluate the effectiveness and stimulation coverage of closed-loop spinal cord stimulation CL-SCS therapy in patients with cervical lead placement
Study design An observational prospective multi-center single-arm study Study population Up to 40 subjects eligible for SCS trial and permanent implant with a minimum of pain intensity of 510 on NRS at baseline will be enrolled
Objectives
Evaluate stimulation coverage in pain area and other parts of the body sensation awareness and quality and pain relief using a 0-10 numeric rating score NRS in patient implanted with one or two leads at cervical level receiving closed-loop spinal cord stimulator CL-SCS therapy
Assessment of holistic outcomes measure quality of life in seven health domains physical function fatigue pain interference depressive symptoms anxiety ability to participate in social roles and activities and sleep disturbance assessed by the PROMIS-29 questionnaire
Evaluate medication intake patient satisfaction and patient global impression of change PGIC
Assessment of device data and programming parameters
Neurophysiological measurements neuronal activation conduction velocity and posture change assessment
Inclusion criteria
Subject is deemed a suitable candidate for SCS trail and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System
Subject is 18 years old
Subject is not pregnant or nursing
Subject is willing and capable of giving informed consent Exclusion criteria
Subject currently has an active implantable device including pacemakers spinal cord stimulator or intrathecal drug delivery system
Subject is incapable of understanding or responding to the study questionnaires
Subject is incapable of understanding or operating the patient programmer handset
Burden and Risk
There will be no additional burden associated with participation in the study The data will be collected during the standard of care visits Data collection required by the study protocol will add no additional time to standard clinical appointments as the data will be downloaded from the clinical interface or entered directly into the database
The benefits of this study could enable improved treatment of chronic trunk andor limb pain with the closed loop system and cervical lead placement
Device used in the study The Saluda Medical EvokeTM Closed-Loop Spinal Cord Stimulator CL-SCS System Evoke System The CE marked Evoke System will be used within its licensed use and manuals The Evoke System measures and records spinal cord SC activation resulting from stimulation via evoked compound action potentials ECAPs The Evoke System can be programmed to provide ECAP-controlled closed-loop SCS or open-loop fixed-output traditional SCS ECAPs may be measured and recorded in either stimulation mode
Indication for use The Evoke SCS System is indicated as an aid in the management of chronic intractable pain of the trunk andor limbs and will be used within its licensed indication during this study
Rational This observational prospective data collection is designed to evaluate the effectiveness and stimulation coverage of closed-loop spinal cord stimulation CL-SCS therapy in patients with cervical lead placement
Study design An observational prospective multi-center single-arm study Study population Up to 40 subjects eligible for SCS trial and permanent implant with a minimum of pain intensity of 510 on NRS at baseline will be enrolled
Objectives
Evaluate stimulation coverage in pain area and other parts of the body sensation awareness and quality and pain relief using a 0-10 numeric rating score NRS in patient implanted with one or two leads at cervical level receiving closed-loop spinal cord stimulator CL-SCS therapy
Assessment of holistic outcomes measure quality of life in seven health domains physical function fatigue pain interference depressive symptoms anxiety ability to participate in social roles and activities and sleep disturbance assessed by the PROMIS-29 questionnaire
Evaluate medication intake patient satisfaction and patient global impression of change PGIC
Assessment of device data and programming parameters
Neurophysiological measurements neuronal activation conduction velocity and posture change assessment
Inclusion criteria
Subject is deemed a suitable candidate for SCS trail and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System
Subject is 18 years old
Subject is not pregnant or nursing
Subject is willing and capable of giving informed consent Exclusion criteria
Subject currently has an active implantable device including pacemakers spinal cord stimulator or intrathecal drug delivery system
Subject is incapable of understanding or responding to the study questionnaires
Subject is incapable of understanding or operating the patient programmer handset
Burden and Risk
There will be no additional burden associated with participation in the study The data will be collected during the standard of care visits Data collection required by the study protocol will add no additional time to standard clinical appointments as the data will be downloaded from the clinical interface or entered directly into the database
The benefits of this study could enable improved treatment of chronic trunk andor limb pain with the closed loop system and cervical lead placement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None