Status:
ACTIVE_NOT_RECRUITING
CES for the Treatment of GAD in Young Adults
Lead Sponsor:
Electromedical Products International, Inc.
Collaborating Sponsors:
University of North Carolina, Chapel Hill
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-21 years
Phase:
NA
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 ag...
Detailed 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 clinic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06124014
Start Date
January 26 2024
End Date
March 1 2026
Last Update
December 22 2025
Active Locations (1)
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1
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, United States, 27516