N/A
N=30
Effectiveness of CES on Emotional and Cellular Wellbeing
Anxiety · Depression
Bottom Line
View on ClinicalTrials.gov: NCT03369418 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: HADS Questionnaire Combined Score — 20.3077; 19.909; 11.1538; 15.4545 score on a scale — p=.013
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alpha-Stim Active (Device); Alpha-Stim Inactive (Device)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of California, Los Angeles
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HADS Questionnaire Combined Score |
20.3077; 19.909; 11.1538; 15.4545 | .013 sig |
| SECONDARY Telomere Length |
.6945; .7841 | .33 |
Summary
The investigators aim to use a CES (cranial electrotherapy stimulation) intervention to improve emotional well-being by reducing symptoms of anxiety and depression and to assess for changes in markers of cellular health - specifically, telomere length and telomerase activity
Eligibility Criteria
Inclusion Criteria
- Male
- Within the age range of 18-40 years old
- Score 8-14 on either the anxiety or depression HADS scale as defined as mild (8-10) to moderate (11-14)
- Subjects who receive anxiety, depression, psychiatric or mental health treatment (pharmacological or non-pharmacological) must be on a stable regimen for the past 3 months
- No active suicidal ideation or psychosis (including schizophrenia and bipolar disorder)
- No uncontrolled or progressive severe medical illness (e.g., cancer, uncontrolled diabetes mellitus, active cardiac disease)
- No use of a pacemaker or any other implanted electrical device
- No alcohol consumption greater than 2 units daily
- Ability to independently complete the in-person study questionnaires and sign informed consent form (ICF) without assistance
- Willing to comply with all study procedures and be available for the duration of the study
- No participation in another clinical trial study
Exclusion Criteria
- Not a male
- Younger than 18 years old or older than 40 years old
- Score ≥15 on either the anxiety or depression HADS scale as defined as severe (15-20)
- Subject who receive anxiety, depression, psychiatric or mental health treatment (pharmacological or non-pharmacological) who have not been on a stable regimen for the past 3 months
- Active suicidal ideation or psychosis (including schizophrenia and bipolar disorder)
- History of inpatient treatment or suicidal ideation within the last year
- Use of a pacemaker or any other implanted electrical device
- Unable to independently complete the in-person study questionnaires and sign ICF due to impaired cognitive function
- Unwilling to comply with all study procedures
- Unavailable for the duration of the study
- Current participation in another clinical trial study
- Any other condition that the investigator believes would jeopardize the safety or rights of the subject or would render the subject unable to comply with the study protocol or make use of acquired data non-analyzable
Data sourced from ClinicalTrials.gov (NCT03369418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.