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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).
Results from this study will inform a randomized controlled trial to be conducted in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Experimental | Trigeminal nerve stimulation will occur by placement of electrodes (1.25" silver electrodes Bio-Flex BF4, Biotens/Vermed, Buffalo, New York, USA) bilaterally on the V1 branches of the trigeminal nerve (CNV) located on the forehead. Current will be generated from the EMS 7500 stimulator (TENS Products, Inc., Granby, CO) (Class II medical device) and will be set to a level that is clearly perceptible by each patient (i.e. tingling sensation) but not uncomfortable or painful. Current level will be determined for each patient at baseline and will likely be between 4-6 milliampere (mA). Active stimulation will occur at 120 Hz with a 250 μs pulse width and with a duty cycle of 30 seconds on to 30 seconds off. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trigeminal Nerve Stimulation | Device | Active trigeminal nerve stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Monitor participants for treatment-emergent adverse events and serious adverse events. | 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). | 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. | 4-week visit and 8-week visit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-week visit and 8-week visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Deng | Contact | +1 613-548-7839 | yan.deng@queensu.ca | |
| Rafael Freire, MD PhD | Contact | +1 613-548-7839 | rafael.freire@queensu.ca |
| Name | Affiliation | Role |
|---|---|---|
| Rafael Freire, MD PhD | Department of Psychiatry, Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston Health Sciences Centre | Recruiting | Kingston | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26818103 | Background | Cook IA, Abrams M, Leuchter AF. Trigeminal Nerve Stimulation for Comorbid Posttraumatic Stress Disorder and Major Depressive Disorder. Neuromodulation. 2016 Apr;19(3):299-305. doi: 10.1111/ner.12399. Epub 2016 Jan 28. | |
| 23773978 | Background | Cook IA, Schrader LM, Degiorgio CM, Miller PR, Maremont ER, Leuchter AF. Trigeminal nerve stimulation in major depressive disorder: acute outcomes in an open pilot study. Epilepsy Behav. 2013 Aug;28(2):221-6. doi: 10.1016/j.yebeh.2013.05.008. Epub 2013 Jun 14. |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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This is a traditional feasibility study, which evaluates preliminary safety and effectiveness information. It does not meet the definition of a "device feasibility" study.
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| 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. | 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). | 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). | 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). | Baseline visit, 4-week visit and 8-week visit. |
| 32002936 | Background | Freire RC, Cabrera-Abreu C, Milev R. Neurostimulation in Anxiety Disorders, Post-traumatic Stress Disorder, and Obsessive-Compulsive Disorder. Adv Exp Med Biol. 2020;1191:331-346. doi: 10.1007/978-981-32-9705-0_18. |
| 25650095 | Background | Trevizol AP, Shiozawa P, Sato IA, Calfat EL, Alberto RL, Cook IA, Medeiros HH, Cordeiro Q. Trigeminal Nerve Stimulation (TNS) for Generalized Anxiety Disorder: A Case Study. Brain Stimul. 2015 May-Jun;8(3):659-60. doi: 10.1016/j.brs.2014.12.009. Epub 2014 Dec 31. No abstract available. |