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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

NettleEndo
Device
The NettleEndo device is a portable, home-use transcranial direct current stimulation (tDCS) system designed to deliver low-intensity electrical stimulation to targeted brain regions. The device delivers a constant current of 2 mA in the active stimulation group, targeting the left primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC) through pre-set electrode positioning.
Sham NettleEndo Device
Device
The sham version of the NettleEndo device is visually identical to the active device and is used under the same schedule. The device is pre-programmed to deliver a brief 2 mA current for 20 seconds at the beginning of each session to mimic the initial skin sensations of active stimulation, after which no current is delivered for the remainder of the session. This allows participants to remain blinded to their group assignment. The device is used with the same electrode positioning as the active version.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Active tDCS - NettleEndo DeviceExperimental treatment 1 intervention

Group B: Sham tDCS - NettleEndo DeviceSham comparator 1 intervention

Trial outcomes

Primary outcomes

Change in daily endometriosis-associated pain intensity (NRS)

Average change from baseline in daily self-reported pain intensity related to endometriosis, using a 0-10 Numerical Rating Scale (NRS). This will be measured separately for dysmenorrhea (Dysmenorrhea NRS; DYS NRS) and non-menstrual pelvic pain (Non-Menstrual Pelvic Pain; NMPP NRS). Collected via mobile app. A decrease in NRS, NMPP NRS and DYS NRS scores indicate a better outcome, as it reflects reduced pain intensity.

Time frame

Daily, throughout the study (6 months)

Secondary outcomes

Change in endometriosis-specific quality of life (EHP-30)

Change from baseline in total and subscale scores on the Endometriosis Health Profile-30 (EHP-30), a 30-item scale assessing the quality of life specific to endometriosis. Each item is rated on a 5-point Likert scale (1 = "Not at all," 5 = "Extremely"). The scale includes subscales for Pain, Work, Social Relationships, Health, Sexual Activity, and Emotion, each with its own set of items. The total score ranges from 0 to 120, where 0 = No impact on quality of life and 120 = Maximum impact on quality of life. A higher score indicates worse quality of life.

Time frame

Monthly starting at baseline until the end of the study (6 months)

Change in general health status (EQ-5D-5L)

Change from baseline in EQ-5D-5L index scores, a 5-item scale assessing general health status. Each item is rated on a 5-point Likert scale (1 = No problems, 5 = Unable to do). The total index score is calculated based on responses across all five domains, with the score ranging from 0 (representing worst possible health) to 1 (representing best possible health). A higher score indicates better health status.

Time frame

Monthly starting at baseline until the end of the study (6 months)

Change in severity of illness and improvement over time (CGI)

The Clinical Global Impressions (CGI) scale is a brief, 3-item rating tool used by clinicians to assess the severity of a patient's illness, their improvement over time, and the efficacy of their treatment.

Time frame

Monthly starting at baseline until the end of the study (6 months)

Other outcomes

Device adherence (number of sessions completed)

Total number of NettleEndo sessions completed over the 12-week intervention period, recorded by the device and app logs.

Time frame

Week 1 to Week 12

Exploratory - Change in pain catastrophizing (PCS)

Change from baseline in total score on the Pain Catastrophizing Scale (PCS), which consists of 13 items, each scored on a 5-point Likert scale (0 = Not at all, 4 = Extremely). The total score ranges from 0 to 52, with higher scores indicating more severe pain catastrophizing.

Time frame

Monthly starting at baseline until the end of the study (6 months)

Exploratory - Change in insomnia severity (ISI)

Change from baseline in total score on the Insomnia Severity Index (ISI), a 7-item self-report measure where each item is rated on a 0 to 4 scale. The total score is the sum of these ratings, with scores ranging from 0 to 28, where 0 = No insomnia and 28 = Severe insomnia. A higher score indicates worse insomnia severity.

Time frame

Monthly starting at baseline until the end of the study (6 months)

Daily medication use (analgesic and hormonal)

Daily use of pain medications and hormonal treatments recorded by participants via mobile app.

Time frame

Daily, throughout the study (6 months)