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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06124014
Other study ID # 22-3341
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 26, 2024
Est. completion date March 2026

Study information

Verified date February 2024
Source Electromedical Products International, Inc.
Contact Tobias Schwippel, MD
Phone 919-966-9929
Email tobias_schwippel@unc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study examines (1) the efficacy of CES with the Alpha-Stim AID ® for the treatment of GAD in young adults (18-21 years of age) in a double-blind, sham-controlled parallel group single-site clinical trial of 130 participants. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date March 2026
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 21 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
At-Home Stimulation
The stimulation paradigm in this trial consists of six weeks of daily, 60-minute at-home stimulation sessions.

Locations

Country Name City State
United States Carolina Center for Neurostimulation Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Electromedical Products International, Inc. University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Hamilton Anxiety Rating Scale (HAM-A) change Change in HAM-A between twelve-week follow-up (FU2) and D1; minimum value is 0, maximum value is 56. Higher scores indicate worse outcome. 84 days
Secondary Beck Anxiety Inventory (BAI) Change Change in BAI between FU1 and D1; minimum value is 0, maximum value is 63. Higher scores indicate worse outcome. 42 days
Secondary Beck Anxiety Inventory (BAI) Change Change in BAI between FU2 and D1; minimum value is 0, maximum value is 63. Higher scores indicate worse outcome. 84 days
Secondary Generalized-Anxiety Disorder 7-item (GAD-7) Change Change in GAD-7 between FU1 and D1; minimum value is 0, maximum value is 21. Higher scores indicate worse outcome. 42 days
Secondary Generalized-Anxiety Disorder 7-item (GAD-7) Change Change in GAD-7 between FU2 and baseline D1; minimum value is 0, maximum value is 21. Higher scores indicate worse outcome. 84 days
Secondary Response/Remission of anxiety Response/remission rates based on HAM-A scores from FU1 versus baseline D1 42 days
Secondary Response/Remission of anxiety Response/remission rates based on HAM-A scores from FU2 versus baseline D1 84 days
Secondary Change in Clinical Global Impression Scale (CGI) Change in CGI from FU1 to D1; CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes. 42 days
Secondary Change in Clinical Global Impression Scale (CGI) Change in CGI from FU2 to baseline D1; CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes. 84 days
Secondary Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF) Change in Q-LES-Q-SF from FU1 to D1; minimum value is 14, maximum value is 70. Higher scores indicate better outcome. 42 days
Secondary Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF) Change in Q-LES-Q-SF from FU2 to D1; minimum value is 14, maximum value is 70. Higher scores indicate better outcome. 84 days
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