Clinical trial NCT06278909: Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study
Official title: Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a traditional feasibility study, which evaluates preliminary safety and effectiveness information. It does not meet the definition of a "device feasibility" study.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) criteria for generalized anxiety disorder.
* Subjects on a stable dose of an selective serotonin reuptake inhibitor (SSRI) or serotonin and noradrenaline reuptake inhibitor (SNRI) for at least 8 weeks.
* Treatment-resistant - treatment resistance will be defined as lack of response to at least two drugs, from two different classes of drugs considered first-line or second-line for GAD. Only trials lasting at least 8 weeks, and with at least the minimum effective dose of the given medication will be considered failed trials.

Exclusion Criteria:

* Moderate to severe major depressive disorder
* Moderate to high suicidality
* Diagnosis of obsessive compulsive disorder (OCD), PTSD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities and dementia or other neurological diseases including trigeminal neuralgia
* Pregnant or breastfeeding women
* Participants who are experiencing seizures
* Implanted vagal nerve stimulation (VNS) or other electrical devices
* Participants who are already undergoing transcutaneous electrical nerve stimulation
* Consumption of cannabis, any cannabis by-products, illicit drugs, or alcohol above 3 drinks per week
* Consumption of natural health products that may affect anxiety or depression symptoms

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: Throughout the study, 8 weeks
measure: Incidence of treatment-emergent side effects measured with the NSEC
timeFrame: Baseline visit, 4-week visit and 8-week visit.
measure: Response to treatment defined by CGI-I score below 3
timeFrame: 4-week visit and 8-week visit.
Secondary outcomes:
measure: Remission defined by CGI-S score below 3
timeFrame: 4-week visit and 8-week visit.
measure: Change in anxiety severity measured by CGI-S
timeFrame: Baseline visit, 4-week visit and 8-week visit.
measure: Change of anxiety symptoms measured with GAD-7
timeFrame: Baseline visit, 4-week visit and 8-week visit.
measure: Change of anxiety symptoms measured with PSWQ
timeFrame: Baseline visit, 4-week visit and 8-week visit.
measure: Change of anxiety symptoms measured with BAI
timeFrame: Baseline visit, 4-week visit and 8-week visit.
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Department of Psychiatry, Queen's University
name: Rafael Freire, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.