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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Active trigeminal nerve stimulation
Kingston Health Sciences Centre
Kingston, Ontario, Canada
RECRUITINGIncidence of treatment-emergent adverse events
Monitor participants for treatment-emergent adverse events and serious adverse events.
Time frame: Throughout the study, 8 weeks
Incidence of treatment-emergent side effects measured with the NSEC
Monitor participants for minor treatment-emergent side effects measured with the Neurostimulation Side-Effect Checklist (NSEC). NSEC is a list of 31 possible side effects from neurostimulation or from antidepressants. Each item is rated from 0 (absent) to 3 (severe).
Time frame: Baseline visit, 4-week visit and 8-week visit.
Response to treatment defined by CGI-I score below 3
Response to treatment, which will be defined as a score of 1 or 2 on the Clinical Global Impression - Improvement (CGI-I) scale. CGI-I is a clinician administered one-item clinical scale rated from 1 (very much improved) to 7 (very much worse). Not assessed would confer score 0.
Time frame: 4-week visit and 8-week visit.
Remission defined by CGI-S score below 3
Remission will be defined as a score of 1 or 2 on the Clinical Global Impression - Severity (CGI-S) scale. CGI-S is a clinician administered one-item clinical scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Not assessed would confer score 0.
Time frame: 4-week visit and 8-week visit.
Change in anxiety severity measured by CGI-S
Changes in scores for CGI-S by comparing the scores in each visit. CGI-S is a clinician administered one-item clinical scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Not assessed would confer score 0.
Time frame: Baseline visit, 4-week visit and 8-week visit.
Change of anxiety symptoms measured with GAD-7
Changes in scores for Generalized Anxiety Disorder 7-item scale (GAD-7) by comparing the scores in each visit. GAD-7 is a self-rated 7-item scale, each item is rated from 0 (not at all) to 3 (nearly every day).
Time frame: Baseline visit, 4-week visit and 8-week visit.
Change of anxiety symptoms measured with PSWQ
Changes in scores for Penn State Worry Questionnaire (PSWQ) by comparing the scores in each visit. PSWQ is a self-rated 16-item scale, each item is rated from 1 (not at all typical of me) to 5 (very typical of me).
Time frame: Baseline visit, 4-week visit and 8-week visit.
Change of anxiety symptoms measured with BAI
Changes in scores for Beck Anxiety Inventory (BAI) by comparing the scores in each visit. BAI is a self-rated 21-item scale, each item is rated from 0 (not at all) to 3 (severely - it bothered me a lot).
Time frame: Baseline visit, 4-week visit and 8-week visit.
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