None listed
Conditions
Brief summary
This is a pilot randomised controlled trial study. Twenty participants with a clinical or imaging-based diagnosis of endometriosis who are scheduled for laparoscopic excision surgery will receive a pre-operative course of home-based tDCS (active or sham). The primary purpose is to assess feasibility metrics and obtain preliminary effect size estimates to power a subsequent randomised controlled trial.
Interventions
Participants will receive a pre-operative course of home-based transcranial direct current stimulation (tDCS) targeting the primary motor cortex (M1). The intervention will be self-administered at home following a 1 hour in-person training session, provided by a member of the research team.
tDCS Stimulation will be delivered using the Soterix mini-CT Stimulator (Soterix Medical Inc., New York, USA) with a coded study mode. The device delivers a constant current via two pre-saturated SNAPpad sal
Participants will receive a pre-operative course of home-based transcranial direct current stimulation (tDCS) targeting the primary motor cortex (M1). The intervention will be self-administered at home following a 1 hour in-person training session, provided by a member of the research team. tDCS Stimulation will be delivered using the Soterix mini-CT Stimulator (Soterix Medical Inc., New York, USA) with a coded study mode. The device delivers a constant current via two pre-saturated SNAPpad saline-soaked sponge electrodes (5x7cm) fitted into a custom headpiece. Electrode positions are set up at the training session and participants are not required to adjust them during the home-based phase. During active tDCS, a constant current of 2mA will be applied for 20 minutes. The anode electrode will be placed over M1 contralateral to the side of dominant pelvic pain, positioned according to the International 10-20 system (position C3 or C4). The reference cathode will be placed over the ipsilateral supraorbital region. Participants will complete five consecutive daily sessions, finishing 3-5 days prior to their planned surgery. Each day, participants will receive a single-use treatment code to input into the device to commence stimulation. Device settings cannot be modified by the participant. Participants will receive a completion code after the 20-minute session is finished, that they will send to the research team to confirm session completion
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the following criteria: • Aged 18 years or over. • Diagnosis of endometriosis based on clinical examination and/or imaging findings (transvaginal ultrasound or MRI). • No prior surgery for endometriosis. • No abdominal surgery in the previous six months. • Attending the gynaecology clinic, pre-operation planning and having laparoscopic excision endometriosis surgery at The Royal Hospital for Women, Randwick. • Surgery scheduled at least four weeks from the anticipated date of consent. • Residing in Australia during the study period. • Willing and able to provide informed consent and adhere to the protocol. • Able to understand and communicate in English. • Has reliable internet or mobile access for remote monitoring and daily questionnaire completion.
Exclusion criteria
Participants presenting with any of the following will be excluded: Endometriosis and surgical exclusions: • Comorbid acute or chronic pain condition other than endometriosis that, in the opinion of the investigative team, would confound assessment of outcomes. • Any endometriosis-related surgery planned or undertaken in the six months prior to enrolment. • tDCS safety contraindications (assessed via TMS/tDCS Adult Safety Screen questionnaire). Developed by Rossi and Rossini, a copy of the document is provided in the HREA attachments. This covers: • History of epilepsy or seizure disorder. • Electronic or metal implants in the head (e.g., cochlear implants, deep brain stimulators, intracranial metal plates or clips). • Cognitive impairment that would preclude safe independent self-administration of the tDCS device. • Current use of benzodiazepines (known to interfere with tDCS-induced neuroplasticity). • Opioid use exceeding a daily morphine equivalent dose of 40mg (known to interfere with sensorimotor and cognitive function in ways that may confound outcomes). • Current or past history of a significant neurological disorder (e.g., stroke, traumatic brain injury, demyelinating disease).
Outcome results
None listed