Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
130 participants
INTERVENTIONAL
2024-01-26
2026-03-31
Brief Summary
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Detailed Description
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Participants will be randomized into receiving either active CES (at least 200uA, up to 500uA at 0.5Hz, 60 minutes daily for six weeks) or sham CES with the Alpha-Stim AID ® device at-home. Clinical assessments of anxiety symptoms are performed at Screening (for eligibility), Baseline, Follow-Up 1 (at completion of intervention, 6 weeks after initial stimulation), and Follow-Up 2 (12 weeks after initial stimulation). Additional assessments of depression symptoms and quality of life are included. Resting-state EEG will be collected at baseline and Follow-Up 1 (in up to 60 participants) for exploratory investigation of mechanism of action.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cranial Electrotherapy Stimulation (CES)
Alpha-Stim AID ® is an FDA-cleared device for the treatment of anxiety that delivers CES through two earclip electrodes.
At-Home Stimulation
The stimulation paradigm in this trial consists of six weeks of daily, 60-minute at-home stimulation sessions.
Sham Cranial Electrotherapy Stimulation (CES)
The device for sham stimulation is physically identical and delivers a non-therapeutic dose of stimulation to replicate salient features of device usage.
At-Home Stimulation
The stimulation paradigm in this trial consists of six weeks of daily, 60-minute at-home stimulation sessions.
Interventions
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At-Home Stimulation
The stimulation paradigm in this trial consists of six weeks of daily, 60-minute at-home stimulation sessions.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
21 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Electromedical Products International, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Samantha Meltzer-Brody, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Carolina Center for Neurostimulation
Chapel Hill, North Carolina, United States
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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Link to more information and study recruitment for interested potential participants.
Other Identifiers
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22-3341
Identifier Type: -
Identifier Source: org_study_id