Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351111
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-11
First Post:
2024-03-05
Brief Title:
Vagus Nerve Stimulation VNS in Spinal Cord Injury SCI Adaptive Follow-On Study
Sponsor:
Redacted
Organization:
Redacted
Study Overview
Official Title:
Vagus Nerve Stimulation VNS in Spinal Cord Injury SCI Adaptive Follow-On Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
True
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCI-AFOS
Brief Summary:
This study is an open label extension of the SCI EFS clinical trial NCT04288245 that developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury The objectives of this study are to provide continued safety assessment for the investigational ReStore system and to gain further estimate of the effect of Vagus Nerve Stimulation VNS with rehabilitative exercises in three different tracks - upper limb UL lower limb LL and bladder control BC for participants with chronic SCI Spinal Cord Injury
Detailed Description:
A prospective multi-center non-randomized open label extension of the SCI EFS trial NCT04288245 participants implanted with the investigational ReStore Device for VNS Therapy Following the completion of Phase 2 of the SCI EFS study participants can enroll to one of the three tracks Under each track participants will undergo up to 36 sessions of rehabilitative exercises self-paced by participants with targeted completion of 3 sessions per week Evaluations will be administered at the beginning and end of each track additional progress checks may be conducted as required by the staff to monitor participant progress Upon completion of a paradigm participants can choose to re-enroll in the same or a different track Adverse events will be documented and assessed throughout the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None