Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-11 @ 2:48 PM
Study NCT ID:
NCT04909593
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2021-05-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial: The AIM Study
Status:
COMPLETED
Status Verified Date:
2024-12
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:
AIM
Brief Summary:
The purpose of the study is to assess the feasibility of using information extracted from physiologic signals to automatically adjust stimulation in patients undergoing Spinal Cord Stimulation (SCS).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: