Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-03 @ 7:16 AM
Study NCT ID:
NCT01962558
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2013-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus
Sponsor:
MicroTransponder Inc.
Organization:
Study Overview
Official Title:
A Blinded Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus vs. VNS With Unpaired Tones
Status:
COMPLETED
Status Verified Date:
2018-03
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:
Assess the safety and efficacy of VNS paired with tones for tinnitus using a randomized, controlled, parallel study design.
Detailed Description:
Patients who have moderate to severe tinnitus, at least one year post diagnosis, may enroll. All patients will be implanted and randomized to one of two groups:
* a group receiving VNS paired with tones and;
* a group that receives VNS and tones, but with different settings.
After device use training, therapy is delivered at home by the patient for 6 weeks. Patients have eight baseline audiometric assessments along with two questionnaire assessments, an assessment after recovery before treatment starts, and tinnitus assessments every two weeks during therapy through the 6 week randomized portion of the study. After the randomized portion, all patients receive VNS paired with tones. Patients will continue to return for quarterly visits and tinnitus assessments through the first year after implant, regardless of their therapy status. Interested patients can continue to receive longer-term treatment after the first year. A goal of up to 30 patients enrolled and implanted across four sites is planned for this study.
* a group receiving VNS paired with tones and;
* a group that receives VNS and tones, but with different settings.
After device use training, therapy is delivered at home by the patient for 6 weeks. Patients have eight baseline audiometric assessments along with two questionnaire assessments, an assessment after recovery before treatment starts, and tinnitus assessments every two weeks during therapy through the 6 week randomized portion of the study. After the randomized portion, all patients receive VNS paired with tones. Patients will continue to return for quarterly visits and tinnitus assessments through the first year after implant, regardless of their therapy status. Interested patients can continue to receive longer-term treatment after the first year. A goal of up to 30 patients enrolled and implanted across four sites is planned for this study.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2U44DC010084-04 | NIH | None | https://reporter.nih.gov/quic… | View |