Wearable Brain-Zapping device aims to ease Period-Related mood and brain fog
NCT ID NCT07679074
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests a 12-week digital program called Samphire Guided Care for people with menstrual or pelvic health conditions like PMS, endometriosis, or menopause. The program combines a wearable device that gently stimulates the brain, coaching, and symptom tracking to see if it improves mood, focus, and work productivity. Researchers will measure changes in work impairment and quality of life in 50 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lutea transcranial direct current stimulation (tDCS) device
- What this could lead to
- If effective, this program could offer a non-drug, at-home option to ease mood and cognitive symptoms tied to menstruation, perimenopause, or menopause.
- What could go wrong
- This is a small, early-stage study with only 50 participants and no placebo group, so results may not be generalizable. The device is not FDA-cleared as a medical treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Alethios Digital Research Platform (Decentralized)
RECRUITINGSan Francisco, California, 94105, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can Pre-Surgery pelvic floor therapy stop endometriosis pain after the operation?
- Can strength training steady the walk and strengthen the pelvic floor after menopause?
- Can a brazilian diet calm menopause hot flashes?
- Appendix: the hidden driver of endometriosis pain?
- Allergy pill put to the test against endometriosis pain
- Can ultrasound and tissue clues reveal which endometriosis lesions carry cancer risk?