Using cranial electrotherapy stimulation to treat anxiety in young adults

Cranial Electrotherapy Stimulation (CES) for the Treatment of Generalized Anxiety Disorder (GAD) in Young Adults: Double-Blind Sham-Controlled Randomized Clinical Trial

This study is testing whether a treatment called cranial electrotherapy stimulation can help young adults aged 18 to 21 with anxiety feel better over six weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 21 Years
• Sex: All
• Sponsor: Electromedical Products International, Inc. (Industry-sponsored)
• Locations: 1 site (Chapel Hill, North Carolina)
• Trial ID: NCT06124014 on ClinicalTrials.gov

What this trial studies

This research investigates the effects of cranial electrotherapy stimulation (CES) on symptoms of generalized anxiety disorder (GAD) in young adults aged 18 to 21. The study is designed as a double-blind, sham-controlled trial involving 130 participants who will be randomly assigned to receive either active CES or sham CES at home for six weeks. Clinical assessments will measure anxiety symptoms at various points, including baseline and follow-ups at six and twelve weeks post-intervention. Additionally, the study will explore the mechanism of action through resting-state EEG in a subset of participants.

Who should consider this trial

Good fit: Ideal candidates are young adults aged 18 to 21 diagnosed with generalized anxiety disorder and experiencing at least mild-to-moderate symptoms.

Not a fit: Patients with severe anxiety symptoms or those not willing to comply with study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive option for alleviating anxiety symptoms in young adults with GAD.

How similar studies have performed: Previous studies have shown promise with CES for anxiety treatment, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Capable of signing informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study including refraining from changes to treatment unless medically indicated and communicated to the study team.
* Aged 18 - 21 at time of screening visit.
* Diagnosis of generalized anxiety disorder (GAD).
* At least mild-to-moderate symptom severity, as indicated by scores of 15 or higher on the clinician-administered HAM-A at the screening visit.
* Concurrent psychiatric medications are allowed. Participants will be required to maintain a sable dose of medications, or remain medication free, for 2 weeks prior to the screening visit, except for antidepressants for which the period of stable dose is 4 weeks prior to screening visit. Concurrent psychotherapy is allowed.
* People of reproductive potential must be willing to use effective contraception (evidence-based hormonal or barrier methods) for at least 1 month prior to the screening visit and agree to use such a method during study participation.

Exclusion Criteria:

Time-frames are determined relative to the screening visit.

* Current (any) or previous (\> 7 stimulation sessions in last 6 weeks) use of a CES device.
* Inability to tolerate the required minimum stimulation amplitude (200 uA) during the initial device training at the baseline visit.
* Experimental or clinical brain stimulation such as deep brain stimulation or transcranial magnetic stimulation for any indication (current or within 60 days prior to screening visit).
* Implanted medical device that uses electricity anywhere in the body.
* Diagnosis (based on MINI) of bipolar I or II (past or current), moderate or severe alcohol use disorder (within 12 months prior to screening visit), moderate or severe (non-alcohol) substance use disorder (within 12 months prior to screening visit), psychotic disorder (current or lifetime), major depressive disorder with psychotic features, bipolar I with psychotic features, anorexia nervosa.
* Epilepsy (current or history). History of febrile childhood seizures and non-epileptic seizures are allowed.
* Pregnant or breast-feeding.
* Enrollment in clinical trial for any condition (current or within 60 days prior to screening visit).
* Hospitalization for any reason (current or past 2 weeks).
* Self-harming behaviors (current or within two years prior to screening visit).
* Higher than low suicide risk on the Columbia Suicide Severity Rating Scale (C-SSRS).
* Known cardiac abnormality or clinically significant heart disease.
* Anything that would make participation in the study unsafe or medically unadvisable in the assessment of a study clinician.

Where this trial is running

Chapel Hill, North Carolina

• Carolina Center for Neurostimulation — Chapel Hill, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Samantha Meltzer-Brody, MD — University of North Carolina, Chapel Hill
• Study coordinator: Zachary Stewart

Conditions Generalized Anxiety Disorder; CES