RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

At-Home Transcranial Direct Current Stimulation (tDCS) Using the NettleEndo Device for Reducing Symptoms of Endometriosis - A Pivotal Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Quick Facts

Study Start:2025-12-04
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06974773

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Nirav Shah, MD, MPH
CONTACT
+1 650-206-8006
nirav@investigator.alethios.com
Zeenia Framroze, BA MPhil
CONTACT
support@alethios.com

Principal Investigator

Nirav Shah, MD, MPH
PRINCIPAL_INVESTIGATOR

Study Locations (Sites)

Alethios, Inc.
San Francisco, California, 94109
United States

Collaborators and Investigators

Sponsor: Samphire Group, Inc.

  • Nirav Shah, MD, MPH, PRINCIPAL_INVESTIGATOR

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-12-04
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2025-12-04
Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

  • Endometriosis
  • Dysmenorrhea
  • Chronic Pelvic Pain
  • tDCS
  • Neuromodulation
  • Women's Health

Additional Relevant MeSH Terms

  • Endometriosis