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Recruiting NCT06278909

Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study

No phase Interventional Generalized Anxiety Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trigeminal Nerve Stimulation.
Who it may be relevant to
Registry conditions: Generalized Anxiety Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Trigeminal Nerve Stimulation
    Active trigeminal nerve stimulation

Primary outcome measures

  • Incidence of treatment-emergent adverse events [Time frame: Throughout the study, 8 weeks]
  • Incidence of treatment-emergent side effects measured with the NSEC [Time frame: Baseline visit, 4-week visit and 8-week visit.]
  • Response to treatment defined by CGI-I score below 3 [Time frame: 4-week visit and 8-week visit.]
Secondary outcome measures (5)
  • Remission defined by CGI-S score below 3 [Time frame: 4-week visit and 8-week visit.]
  • Change in anxiety severity measured by CGI-S [Time frame: Baseline visit, 4-week visit and 8-week visit.]
  • Change of anxiety symptoms measured with GAD-7 [Time frame: Baseline visit, 4-week visit and 8-week visit.]
  • Change of anxiety symptoms measured with PSWQ [Time frame: Baseline visit, 4-week visit and 8-week visit.]
  • Change of anxiety symptoms measured with BAI [Time frame: Baseline visit, 4-week visit and 8-week visit.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Kingston Health Sciences Centre — Kingston

Publications

  • 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. PMID 26818103
  • 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. PMID 23773978
  • 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. PMID 32002936
  • 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. PMID 25650095

Identifiers

NCT: NCT06278909 · 6036699

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗