Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278909
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-02-09
Brief Title:
Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder a Feasibility Study
Sponsor:
Dr Rafael Freire
Organization:
Queens University
Study Overview
Official Title:
Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder a Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This is a feasibility study for trigeminal nerve stimulation TNS in patients with treatment-resistant generalized anxiety disorder TR-GAD Ten participants will receive TNS for 8 weeks as an augmentation strategy to pharmacological treatment for generalized anxiety disorder GAD
The primary objective is to ascertain if TNS is a safe and well-tolerated treatment for patients with TR-GAD
The secondary objective will be to monitor changes in GAD symptom severity throughout the study
Results from this study will inform a randomized controlled trial to be conducted in the future
The primary objective is to ascertain if TNS is a safe and well-tolerated treatment for patients with TR-GAD
The secondary objective will be to monitor changes in GAD symptom severity throughout the study
Results from this study will inform a randomized controlled trial to be conducted in the future
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?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None