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Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation

Trigeminal Nerve Stimulation in Anxiety Disorders: a Randomized Controlled Trial

NCT04931134•Dr. Rafael Freire

Summary

Primary objectives: The primary objective is to ascertain if trigeminal nerve stimulation is an effective treatment with high tolerability for patients with panic disorder, generalized anxiety disorder and social anxiety disorder.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Meet DSM5 criteria for panic disorder, social anxiety disorder or generalized anxiety disorder.

Exclusion Criteria

•Subjects undergoing cognitive behavioural therapy.
•Subjects undergoing pharmacological treatment for an anxiety disorder.
•Subjects undergoing pharmacological treatment with antidepressants or benzodiazepines.
•Subjects with moderate to severe major depressive disorder based on the PHQ-9 test (score of 15 or above) at baseline.
•Moderate to high current suicidality or "suicide likely in near future" or current suicidal behavior disorder.
•Concurrent diagnosis of OCD, PTSD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities or dementia.
•Subjects diagnosed with neurological diseases including trigeminal neuralgia.
•Pregnant or breastfeeding women.
•Subjects who are experiencing seizures.
•Individuals with implanted VNS or other electrical devices.
+3 more criteria

Locations (1)

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Key Dates

Start Date

February 7, 2022

Primary Completion Date

December 31, 2025

Completion Date

January 31, 2026

Last Updated

April 8, 2025

Enrollment

ACTUAL participants

Conditions

Panic DisorderGeneralized Anxiety DisorderSocial Anxiety Disorder

Interventions

Trigeminal nerve stimulation - active

DEVICE

Trigeminal nerve stimulation - sham

DEVICE

ACTsocially: The (Dis)Similarities of ACT for Changing Internalizing and Externalizing Symptomatology in Adolescence

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Social Anxiety Disorder (SAD)Oppositional Defiant Disorder

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RECRUITINGNA

Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation

Inclusion Criteria

Exclusion Criteria

ACTsocially: The (Dis)Similarities of ACT for Changing Internalizing and Externalizing Symptomatology in Adolescence

Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

Individual Factors of CBT Underlying Success

Comparing TBT to Disorder-Specific Psychotherapy in Veterans With Social Anxiety Disorder

Study to Assess Adverse Events and Change in Disease Activity When Oral ABBV-932 is Added to Antidepressant Therapies in Adult Participants With Generalized Anxiety Disorder