Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2026-02-28 @ 9:25 PM
Study NCT ID:
NCT02896361
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2016-09-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Burst Optimized Stimulation Study
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Burst Optimized Stimulation Study
Status:
COMPLETED
Status Verified Date:
2019-05
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:
BOSS
Brief Summary:
This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.
Detailed Description:
This is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms.
Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.
Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.
Study Oversight
Has Oversight DMC:
False
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?: