tDCS for endometriosis-related CPP - v1.0
Research type
Research Study
Full title
At-Home Transcranial Direct Current Stimulation on Endometriosis-related Chronic Pelvic Pain: Randomised, Double-Blind, Sham-Controlled Trial
IRAS ID
350170
Contact name
Emile Radyte
Contact email
Sponsor organisation
Samphire Neuroscience
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
This study will investigate the effectiveness of a novel, non-invasive neuromodulation treatment called transcranial Direct Current Stimulation (tDCS), delivered via the Nettle device, for reducing chronic pelvic pain (CPP) associated with endometriosis. Nettle is already MHRA-registered, CE-marked, and validated for the treatment of mood and pain symptoms associated with menstruation. Endometriosis affects millions of women worldwide, causing debilitating pain and severely impacting quality of life. Current treatments, including medications, hormonal therapies, and surgery, often provide insufficient relief and have significant side effects.
This trial is designed as a double-blind, randomised, sham-controlled study to evaluate the efficacy of 20 days of at-home tDCS stimulation via Nettle in reducing both pain and mood-related symptoms in women suffering from endometriosis-related CPP. Participants will be randomly assigned to either the active tDCS group or a sham-control group. Pain severity will be measured using the Numerical Rating Scale (NRS), while secondary outcomes will assess quality of life, mood disturbances, and medication use.
The study will recruit 40 women aged 18-50, diagnosed with endometriosis and experiencing CPP, from University College London Hospital (UCLH). Participants will use the Nettle device for 20-minute daily sessions over 20 days and complete questionnaires to track pain, mood, and quality of life throughout the intervention and a one-month follow-up period.
The results from this trial will provide valuable insights into the potential of tDCS as an effective and patient-friendly treatment for endometriosis-related pain, aiming to improve the quality of life for women with this chronic, debilitating condition.
REC name
London - Riverside Research Ethics Committee
REC reference
24/PR/1445
Date of REC Opinion
5 Dec 2024
REC opinion
Further Information Favourable Opinion