Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups

ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22-45
SponsorSamphire Group, Inc.

About this trial

The goal of this clinical trial is to learn if a wearable brain stimulation device called NettleEndo can reduce chronic pelvic pain and improve wellbeing in women with endometriosis. The study also aims to assess the safety and usability of the device when used at home over several months.

The main questions it aims to answer are:

1. Does at-home transcranial direct current stimulation (tDCS) reduce daily pain intensity in women with endometriosis? 2. Does the device also improve mood and sleep quality?

Researchers will compare two groups-one receiving active brain stimulation and one receiving a sham (placebo) stimulation-to see if the active device provides greater improvements in symptoms.

Participants will:

1. Use the NettleEndo device at home for 20 minutes per session, five times per week for 12 weeks 2. Be randomly assigned to receive either real or sham stimulation through the device 3. Complete daily and weekly symptom ratings through a mobile app 4. Be followed for 90 days after completing the intervention to monitor longer-term effects

All activities are completed remotely using a smartphone app. Participants can contact the study team with questions at any time. The study is double-blind, meaning neither participants nor the researchers assessing outcomes will know who received active or sham treatment until the end of the trial.

Eligibility criteria

Qualifiers

Female, 22-45 years old

Assigned female at birth

Fluent in English

Capacity to consent

Disqualifiers

Pregnancy/breastfeeding or planning to become pregnant in next 6 months

History of epileptic neurological conditions in the immediate family

Severe/untreated neurological disease (e.g., epilepsy or seizure disorders, stroke or transient ischemic attack [TIA], subarachnoid hemorrhage, traumatic brain injury [TBI] with persistent neurological deficits, brain tumors [malignant or benign], multiple sclerosis, Parkinson's disease, Alzheimer's disease or other dementias, Huntington's disease, cerebral aneurysms or arteriovenous malformations [AVMs], active central nervous system infections [e.g., meningitis, encephalitis], hydrocephalus, other neurodegenerative diseases not otherwise specified, or any other neurological condition that, in the opinion of the principal investigator, may increase risk or interfere with study participation or outcomes)

Metal implants/electronic devices in brain, head, or neck area

Trial design

Treatments tested in this trial

  • NettleEndo
  • Sham NettleEndo Device

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Samphire Group, Inc.

Lead sponsor

Alethios, Inc.

Collaborator