Lutea Transcranial Direct Current Stimulation (tDCS) DeviceSamphire Guided Care Program
Lutea 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.
Samphire 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.
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Alethios Digital Research Platform (Decentralized)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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