About this trial

This study evaluates the feasibility and efficacy of the Samphire Guided Care (SGC) program

* a 12-week structured digital health program combining clinician-led onboarding, at-home neuromodulation using the Lutea tDCS device, neuromodulation coach support, and app-based symptom tracking - on work productivity, employee wellbeing, and quality of life in individuals experiencing mood and cognitive symptoms associated with menstruation, perimenopause, or menopause.

Eligibility criteria

Qualifiers

Self-identified female, aged 18-65 years at the time of enrollment

Basic English literacy

Able and willing to provide informed consent electronically

Residing in the United States

Disqualifiers

Pregnancy, breastfeeding, or actively planning pregnancy during the study period

History of epilepsy or seizure disorder

Severe or unstable neurological disease that, in the opinion of the study team, may increase risk or interfere with participation

Implanted electronic or metal devices in the head, neck, or brain region contraindicated for tDCS use

Trial design

Treatments tested in this trial

  • Lutea Transcranial Direct Current Stimulation (tDCS) Device
  • Samphire Guided Care Program

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

1
Alethios Digital Research Platform (Decentralized)94105, San FranciscoCalifornia, United States

Sponsors and collaborators

Samphire Group, Inc.

Lead sponsor