NCT06124014

Brief Summary

The purpose of this research study is to study cranial electrotherapy stimulation (CES) to determine its effects on symptoms of anxiety in people with generalized anxiety disorder (GAD) between the ages of 18 - 21 years of age.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 26, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
Last Updated

March 18, 2026

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

October 20, 2023

Last Update Submit

March 16, 2026

Conditions

Generalized Anxiety Disorder

Keywords

CES

Outcome Measures

Primary Outcomes (1)

  • Hamilton Anxiety Rating Scale (HAM-A) change

    Change in HAM-A between six-week follow-up (FU1) and baseline (D1); minimum value is 0, maximum value is 56. Higher scores indicate worse outcome.

    42 days

Secondary Outcomes (11)

  • Hamilton Anxiety Rating Scale (HAM-A) change

    84 days

  • Beck Anxiety Inventory (BAI) Change

    42 days

  • Beck Anxiety Inventory (BAI) Change

    84 days

  • Generalized-Anxiety Disorder 7-item (GAD-7) Change

    42 days

  • Generalized-Anxiety Disorder 7-item (GAD-7) Change

    84 days

  • +6 more secondary outcomes

Study Arms (2)

Cranial Electrotherapy Stimulation (CES)

EXPERIMENTAL

Alpha-Stim AID ® is an FDA-cleared device for the treatment of anxiety that delivers CES through two earclip electrodes.

Device: At-Home Stimulation

Sham Cranial Electrotherapy Stimulation (CES)

SHAM COMPARATOR

The device for sham stimulation is physically identical and delivers a non-therapeutic dose of stimulation to replicate salient features of device usage.

Device: At-Home Stimulation

Interventions

At-Home StimulationDEVICE

The stimulation paradigm in this trial consists of six weeks of daily, 60-minute at-home stimulation sessions.

Cranial Electrotherapy Stimulation (CES)Sham Cranial Electrotherapy Stimulation (CES)

Eligibility Criteria

Age18 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolina Center for Neurostimulation

Chapel Hill, North Carolina, 27516, United States

Location

Related Publications (5)

  • Barclay TH, Barclay RD. A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. J Affect Disord. 2014 Aug;164:171-7. doi: 10.1016/j.jad.2014.04.029. Epub 2014 Apr 21.

    PMID: 24856571BACKGROUND

  • Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015 Sep;17(3):327-35. doi: 10.31887/DCNS.2015.17.3/bbandelow.

    PMID: 26487813BACKGROUND

  • Goodwin RD, Weinberger AH, Kim JH, Wu M, Galea S. Trends in anxiety among adults in the United States, 2008-2018: Rapid increases among young adults. J Psychiatr Res. 2020 Nov;130:441-446. doi: 10.1016/j.jpsychires.2020.08.014. Epub 2020 Aug 21.

    PMID: 32905958BACKGROUND

  • Hajek A, Sabat I, Neumann-Bohme S, Schreyogg J, Barros PP, Stargardt T, Konig HH. Prevalence and determinants of probable depression and anxiety during the COVID-19 pandemic in seven countries: Longitudinal evidence from the European COvid Survey (ECOS). J Affect Disord. 2022 Feb 15;299:517-524. doi: 10.1016/j.jad.2021.12.029. Epub 2021 Dec 15.

    PMID: 34920039BACKGROUND

  • Garakani A, Murrough JW, Freire RC, Thom RP, Larkin K, Buono FD, Iosifescu DV. Pharmacotherapy of Anxiety Disorders: Current and Emerging Treatment Options. Front Psychiatry. 2020 Dec 23;11:595584. doi: 10.3389/fpsyt.2020.595584. eCollection 2020.

    PMID: 33424664BACKGROUND

Related Links

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Samantha Meltzer-Brody, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2023

First Posted

November 9, 2023

Study Start

January 26, 2024

Primary Completion

December 17, 2025

Study Completion

January 21, 2026

Last Updated

March 18, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)