N/A Completed N=30 Randomized Double-blind Treatment

Effectiveness of CES on Emotional and Cellular Wellbeing

Source: ClinicalTrials.gov NCT03369418 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcomePrimary: HADS Questionnaire Combined Score — 20.3077; 19.909; 11.1538; 15.4545 score on a scale — p=.013

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

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.