At-home brain stimulation for chronic pelvic pain in endometriosis: a randomised controlled trial
This study is for women aged 18 to 50 who have ongoing pelvic pain due to endometriosis. Endometriosis is a common condition where tissue similar to the womb lining grows elsewhere, often causing pain. Researchers want to see if using a small device on the head at home, called Nettle, can reduce pain and lift mood. Some participants will get the active treatment, while others will get a dummy treatment. Neither patients nor researchers will know who gets what. The study hopes to find a new way to manage pain without the side effects of usual medicines.
At a glance
What is this study about?
Endometriosis is a common health problem in the UK where tissue similar to the lining of the womb grows outside of it. This often leads to ongoing pain in the pelvis, which can be really difficult to live with and affect daily life. While there are treatments like painkillers and hormone therapies, they don't work for everyone and can sometimes cause unwanted side effects.
This study, run by University College London Hospital (UCLH), is exploring a new approach. Instead of medication, it's looking at a non-invasive treatment called transcranial Direct Current Stimulation (tDCS). This involves using a small device that you wear on your head at home. The idea is that gentle electrical currents can help change how the brain processes pain, potentially leading to less pain and improved mood.
Researchers want to find out if this Nettle device can be a safe and effective way to help women with endometriosis-related pain. If it works, it could offer a new option for managing this challenging condition, potentially without the side effects that some people experience with current treatments.
Key takeaways
- Exploring a new, at-home brain stimulation device (Nettle) for endometriosis pain.
- Aims to reduce chronic pelvic pain and improve mood without medication side effects.
- Participation involves daily device use for 20 days and smartphone symptom tracking.
- The study is 'double-blind' – you won't know if you're getting active or sham treatment.
- Possible mild side effects include skin irritation or headaches; benefits are potential pain and mood relief.
- Open to women aged 18-50 with diagnosed endometriosis and ongoing pelvic pain.
Who may be eligible?
This study is looking for women who are between 18 and 50 years old. You need to have a confirmed diagnosis of endometriosis and have been experiencing ongoing pelvic pain for at least three months. Your pain should also be at a level of 3 out of 10 or more.
There are some reasons why you might not be able to join. For example, if you have certain brain conditions like severe neurological diseases, a history of brain surgery, tumors, or epilepsy. You also can't take part if you have metal implants in your body (like pacemakers) or open wounds/skin conditions on your scalp where the device would be placed.
Additionally, you cannot be pregnant, planning to become pregnant in the next year, or currently breastfeeding. You also need to be able to use a smartphone for daily updates and be able to give your informed consent to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a woman between 18 and 50 years old?
- Have you been diagnosed with endometriosis?
- Do you have pelvic pain from endometriosis that has lasted more than 3 months?
- Is your pain usually at least a 3 out of 10?
- Do you have a smartphone you can use for the study app (Android or Apple)?
- Are you currently not pregnant, breastfeeding, or planning pregnancy in the next year?
What does participation involve?
If you decide to take part, you'll be assigned to one of two groups by chance. One group will use the Nettle device that gives a gentle electrical stimulation for 20 minutes a day, for 20 days, at home. The other group will use the same device, but it won't deliver any active stimulation – this is called the 'sham' group, and it helps researchers compare the results fairly. Neither you nor the researchers will know which group you are in, which helps keep the study unbiased.
During your participation, you'll use a smartphone app to record how you're feeling, including your pain levels and mood, every day. After one full menstrual cycle, you'll have follow-up assessments. The study itself is expected to run from March 2024 until September 2027.
Potential risks and benefits
Locations (1)
- University College London Hospitals NHS Foundation TrustCity onlyLondon, England
Common questions
What is endometriosis?
Endometriosis is when tissue similar to the lining of the womb grows outside of it, often causing ongoing pelvic pain.
What is brain stimulation?
It's a way of using a gentle electrical current with a device placed on your head to try and change how your brain processes pain.
Will I know if I'm getting the real treatment?
No, this is a 'double-blind' study, meaning neither you nor the researchers will know who is receiving the active treatment.
How long will I need to use the device?
If you're in the treatment group, you'll use it for 20 minutes a day for 20 days.
Who is paying for this study?
The study is being funded by Samphire Neuroscience Ltd. in the UK.
How to find out more
Emile Radyte
Always speak to your GP or specialist before deciding to take part in a study.
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