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.
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
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
Adults assigned female at birth aged 18-65 residing in the United States, currently employed full-time with employer-provided medical benefits, and reporting mood or cognitive symptoms associated with menstruation, perimenopause, or menopause that have been present for at least 3 months and are sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships.
Cohort
Prospective
Lutea Transcranial Direct Current Stimulation (tDCS) Device
DeviceThe Lutea device (Samphire Group, Inc.) is an FCC-registered consumer wellness wearable that delivers low-intensity transcranial direct current stimulation (tDCS) targeting the primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC). Sessions are 20 minutes in duration at a recommended frequency of multiple sessions per week, self- administered at home. The device does not meet the FDA's statutory definition of a medical device; it is intended for general wellness purposes and is not cleared or approved for the diagnosis, cure, mitigation, treatment, or prevention of any disease.
Samphire Guided Care Program
BehavioralA 12-week structured digital health program comprising: clinician-led neuromodulation eligibility assessment and care pathway assignment at onboarding; ongoing neuromodulation coach support; and app-based daily symptom tracking via the Alethios digital research platform. All participants in both groups receive this program component.
Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment
Within-participant change in WPAI Overall Work Impairment subscale score from baseline to end of program. Scores range from 0 to 100%, with higher scores indicating greater impairment. A reduction of 7 percentage points or more is considered clinically meaningful.
EQ-5D-5L Utility Index Score
Within-participant change in EQ-5D-5L utility index score from baseline to end of program. Scores range from 0 to 1, with higher scores indicating better health-related quality of life. A change of 0.07 utility units or more is considered clinically meaningful.
Patient Health Questionnaire-9 (PHQ-9)
Within-participant change in PHQ-9 total score. Range 0-27; higher scores indicate greater depressive symptom severity. MCID: 5 points.
Generalized Anxiety Disorder-7 (GAD-7)
Within-participant change in GAD-7 total score. Range 0-21; higher scores indicate greater anxiety symptom severity. MCID: 4 points.
Insomnia Severity Index (ISI)
Within-participant change in ISI total score. Range 0-28; higher scores indicate greater insomnia severity. MCID: 6 points.
WPAI Absenteeism, Presenteeism, and Activity Impairment Subscales
Within-participant change in WPAI subscale scores for absenteeism (work time missed), presenteeism (impairment while working), and activity impairment (impairment in daily activities). All subscales scored 0-100%; higher scores indicate greater impairment.
Pain Numerical Rating Scale (NRS)
Within-participant change in average pelvic or menstrual pain over the past 7 days. Scored 0-10; higher scores indicate greater pain severity. MCID: 2 points. Exploratory outcome.
Patient Global Impression of Change (PGIC)
Participant-rated overall impression of change in hormonal health symptoms since study start. 7-point scale from Very much improved (1) to Very much worse (7). Exploratory.
Net Promoter Score (NPS)
Participant likelihood to recommend the SGC program. Scored 0-10. Exploratory engagement metric for employer-facing reporting.
Clinical Global Impression of Severity (CGI-S)
Clinician-rated impression of overall symptom severity at onboarding consultation. 7-point scale. Administered by contracted women's health clinician. Exploratory.
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