Recruiting

SGC with Lutea

Sponsor:

Samphire Group, Inc.

Code:

NCT07679074

Conditions

Premenstrual Syndrome

Premenstrual Dysphoric Disorder

Dysmenorrhea

Endometriosis

Perimenopause

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Lutea Transcranial Direct Current Stimulation (tDCS) Device

Samphire Guided Care Program

Study Details

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.

Conditions

Premenstrual Syndrome

Premenstrual Dysphoric Disorder

Dysmenorrhea

Endometriosis

Perimenopause

Study ID

NCT07679074

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Group A - Neuromodulation Cohort

Participants assessed as eligible for neuromodulation at the clinician onboarding consultation who accept the Lutea device and complete at least 30% of recommended tDCS sessions across the 12-week program. Group A participants receive the full SGC program including clinician consultation, Lutea device, neuromodulation coach support, and app-based symptom tracking.

Group B - Comparison Cohort

Participants who either decline the Lutea device following the clinician consultation, or who accept the device but complete fewer than 30% of recommended sessions across the 12-week program. Group B participants receive the same SGC program components as Group A excluding substantive neuromodulation engagement.

Interventions

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.

Primary outcome measure

  • Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment [ Time Frame: Baseline to Week 12 ]
  • EQ-5D-5L Utility Index Score [ Time Frame: Baseline to Week 12 ]

Central Contacts and Locations

Central contacts

Nirav Shah, MD, MPH

6267201547nirav@investigator.alethios.com

Zeenia Framroze

support@alethios.com

Locations

Alethios Digital Research Platform (Decentralized)

Recruiting

San Francisco, California, United States, 94105

Contacts

Zeenia Framroze

support@alethios.com

Principal Investigator:

Nirav Shah, MD, MPH

More Information

Sponsor

Samphire Group, Inc.

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samphire Group, Inc. on 2026-07-01.