Dysmenorrhea, Endometriosis, Menopause, Pelvic Pain, Perimenopause, Premenstrual Dysphoric Disorder, Premenstrual Syndrome
Conditions
Keywords
tDCS, neuromodulation, hormonal health, menstrual symptoms, perimenopause, menopause, PMDD, PMS, work productivity, brain fog, mood, cognitive function, digital health, decentralized clinical trial, guided care
Brief summary
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.
Detailed description
The CREST study is a prospective, observational, two-group cohort study conducted in a fully decentralized, at-home format. No randomization, blinding, or placebo comparator is employed. All enrolled participants receive access to the full SGC program, which includes: a clinician-led eligibility assessment at onboarding conducted by a third-party women's health clinician; at-home transcranial direct current stimulation (tDCS) using the Lutea consumer wellness device (for eligible participants who opt in); ongoing support from a Samphire neuromodulation coach; and app-based symptom tracking via the Alethios digital research platform. Participants are prospectively allocated to one of two groups based on neuromodulation eligibility, device uptake, and adherence: Group A (neuromodulation cohort, target n=35) comprises participants assessed as eligible who accept the device and complete at least 30% of recommended sessions across the 12-week program; Group B (comparison cohort, target n=15) comprises participants who either decline the device or complete fewer than 30% of sessions. Group allocation is determined retrospectively at Week 12 based on automated device usage logs. Both groups complete identical assessment schedules. Primary outcomes are work productivity (WPAI subscales) and employee wellbeing (EQ-5D-5L). Secondary outcomes include PHQ-9, GAD-7, ISI, WPAI, PSST, and BrainHQ cognitive assessment. Exploratory outcomes include pain NRS, PGIC, NPS, HCRU, optional wearable physiological data, and clinician-rated CGI-S and CGI-I. All study activities are conducted remotely via the Alethios digital research platform and Samphire mobile application. Electronic informed consent is obtained prior to any study-related data collection.
Interventions
DEVICELutea Transcranial Direct Current Stimulation (tDCS) Device
The 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.
BEHAVIORALSamphire Guided Care Program
A 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.
Sponsors
Samphire Group, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * Reporting mood or cognitive symptoms associated with menstruation, perimenopause, or menopause (must endorse a minimum of three of the following: irritability, emotional dysregulation, brain fog, fatigue, reduced concentration, sleep disruption, or low mood) * Symptoms present for at least 3 months and sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships * Currently in full-time employment with medical benefits as part of compensation package * Access to a smartphone with internet access compatible with the Samphire mobile application * Able to safely operate the study device in the home environment * Willing to complete baseline, mid-program, and end-of-program questionnaires and engage with the 12-week guided care program
Exclusion criteria
* 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 * Active scalp lesions, open wounds, or dermatologic conditions at electrode sites that may interfere with safe device use * Current diagnosis of schizophrenia, bipolar disorder, or other severe psychiatric condition that would make participation inappropriate, as determined by screening * Active suicidal ideation, recent suicidal behavior, or clinically significant self-injurious behavior, as determined by participant self-report during screening * Inability to provide informed consent or safely use the device in the home environment * Current participation in another interventional neurotechnology or drug study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment | Baseline to Week 12 | 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 | Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | Baseline, Week 6, Week 12 | 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) | Baseline, Week 6, Week 12 | 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) | Baseline, Week 6, Week 12 | 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 | Baseline, Week 6, Week 12 | 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. |
| Premenstrual Symptoms Screening Tool (PSST) | Baseline to Week 12 | Within-participant change in PSST total score across 19 symptom items and 5 functional impact items. Items rated 1-4 (Not at all to Severe); higher scores indicate greater premenstrual symptom burden. |
| BrainHQ Cognitive Assessment | Baseline to Week 12 | Within-participant change in BrainHQ composite cognitive performance score from baseline to end of program. |
| Healthcare Resource Utilization (HCRU) | Baseline to Week 12 | Within-participant change in self-reported healthcare contacts (ER visits, specialist consultations, primary care visits, prescription medication changes) related to hormonal health symptoms, assessed using a study-specific questionnaire adapted from MEPS items. |
Countries
United States
Contacts
CONTACTNirav Shah, MD, MPH
CONTACTZeenia Framroze
PRINCIPAL_INVESTIGATORNirav Shah, MD, MPH
Samphire Group, Inc.
Outcome results
None listed