NettleEndo for Endometriosis

(RELIEF Trial)

Overseen By Zeenia Framroze, BA MPhil

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Samphire Group, Inc.

Disqualifiers: Pregnancy, Neurological conditions, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a wearable brain stimulation device, called NettleEndo, can reduce chronic pelvic pain and improve the overall well-being of women with endometriosis. Participants will use the device at home for 20 minutes per session, five times a week, over three months. The study will compare two groups: one receiving actual brain stimulation and the other using a placebo device to assess the effectiveness of the real treatment. Women diagnosed with endometriosis by a doctor and experiencing chronic pelvic pain may be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options for endometriosis.

Will I have to stop taking my current medications?

The trial requires that your treatment plan be stable, meaning no new medication changes. If you're on hormonal contraception, you must have been using it consistently for at least 6 months. If you're taking pain medications, your regimen should be stable for at least 4 weeks before starting the trial.

What prior data suggests that the NettleEndo device is safe for use in women with endometriosis?

Research has shown that the NettleEndo device, which applies a gentle electrical current to the head, is generally well-tolerated. In studies, participants experienced minor side effects like mild tingling or itching at the application site, but these were not serious. Past studies have reported no major negative effects.

The NettleEndo device is designed for home use, and research indicates that individuals can safely use it independently. It delivers a low electrical current to specific brain areas to help reduce pelvic pain and improve overall well-being. While the treatment is still under study specifically for endometriosis, evidence so far suggests it is safe for long-term use.

Overall, users of similar devices report that these side effects are manageable and temporary. This makes the NettleEndo device a promising option for those seeking relief from endometriosis symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for endometriosis, such as hormonal therapies and surgical options, NettleEndo offers a novel approach using transcranial direct current stimulation (tDCS). This wearable device targets the brain's primary motor cortex and dorsolateral prefrontal cortex with mild electrical currents, potentially altering pain perception and reducing symptoms without the side effects of traditional medications. Researchers are excited about NettleEndo because it allows for at-home use, offering a non-invasive, drug-free alternative that could improve the quality of life for those with endometriosis.

What evidence suggests that the NettleEndo device is effective for endometriosis?

Research suggests that transcranial direct current stimulation (tDCS) might help reduce ongoing pelvic pain in women with endometriosis. Some studies have also found that this brain stimulation could improve mood and sleep quality. This is important because endometriosis often causes pain, mood issues, and sleep problems. In this trial, participants will use the NettleEndo device, which delivers tDCS in a wearable form, allowing for treatment at home. This method offers more convenience and comfort. While more research is needed to confirm these benefits, early results are promising for those seeking alternatives to traditional medication. ^{1 2 3 4 6}

Who Is on the Research Team?

Nirav Shah, MD, MPH

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for women with endometriosis who experience chronic pelvic pain. Participants will use a device at home and track symptoms via an app. They must be willing to follow the study protocol for several months, including daily sessions and symptom tracking.

Inclusion Criteria

Fluent in English

Access to a smartphone with an internet data plan, phone must be iOS 13.4+ or Android 12+

Regular menstrual cycles (24-35 days) for the past six months

Exclusion Criteria

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

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

Participating in any other clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the NettleEndo device at home for 20 minutes per session, five times per week for 12 weeks

12 weeks

Remote monitoring via app

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Remote monitoring via app

What Are the Treatments Tested in This Trial?

Interventions

• NettleEndo

Trial Overview The NettleEndo device, which provides brain stimulation, is being tested against a sham device to see if it can reduce pain, improve mood, and enhance sleep quality in women with endometriosis over a 12-week period at home.

How Is the Trial Designed?

Group I: Active tDCS - NettleEndo Device Experimental Treatment 1 Intervention

Participants assigned to this arm will receive active transcranial direct current stimulation (tDCS) using the NettleEndo wearable device. The device delivers 2 mA of stimulation for 20 minutes per session, five sessions per week, for a total of 12 weeks. Stimulation is delivered over the left primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) using pre-programmed settings. Participants complete all sessions at home and log outcomes via a mobile app. Device use is monitored remotely through digital logs.

Group II: Sham tDCS - NettleEndo Device Placebo Group 1 Intervention

Participants assigned to this arm will receive sham transcranial direct current stimulation (tDCS) using the NettleEndo wearable device. The device mimics the sensation of active stimulation by ramping up to 2 mA for 20 seconds before turning off, with no therapeutic current delivered for the remainder of the 20-minute session. Participants use the device five times per week for 12 weeks. Sessions are completed at home, and outcome measures are recorded via a mobile app. Device use is remotely monitored via app-based logging. Participants and investigators are blinded to group allocation.

Who Is Running the Clinical Trial?

Samphire Group, Inc.

Lead Sponsor

Alethios, Inc.

Collaborator

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06974773/remote-electrical-stimulation-as-a-long-term-intervention-for-endometriosis-flare-ups?id=60&slug=endometriosis

Remote Electrical Stimulation as a Long-term Intervention ... Outcomes include pain intensity, mood, sleep, and quality of life. Randomisation is stratified by hormonal contraceptive use. Interim analyses ...

2. trialx.com trialx.com/clinical-trials/listings/316572/remote-electrical-stimulation-as-a-long-term-intervention-for-endometriosis-flare-ups/

Remote Electrical Stimulation as a Long-term Intervention ... The trial includes a 12-week treatment period followed by a 60-day follow-up phase. Outcomes include pain intensity, mood, sleep, and quality of life.

3. withpower.com withpower.com/trial/nettleendo-for-endometriosis-02db0

NettleEndo for Endometriosis (RELIEF 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 ...

4. isrctn.com isrctn.com/ISRCTN15224642

At-home brain stimulation for chronic pelvic pain in ... - Potential benefits: If effective, the device may help reduce pain and improve mood symptoms in women with endometriosis without the side effects of medication ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02769052

NCT02769052 No information is available for this page.

6. samphireneuro.com samphireneuro.com/en-us/science?srsltid=AfmBOorw3cUsJOBd6wDEJfOcEz8JqDgML-B8Us0AVC_CMTFCH3v6zvn3

Brain-Based Solutions Transforming Women's Health Care Learn how Samphire applies neuroscience to women's health, using brain-based technology to improve hormonal balance, emotional wellbeing, and cycle control.