NCT02958423

tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment

Transcranial Direct Current Stimulation (tDCS) vs Trans-spinal Direct Current Stimulation (tsDCS) for Endometriosis-related Chronic Pelvic Pain Treatment: A Single Center, Prospective, Randomized, Controlled, Parallel Group Pilot Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jean Schoenen · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to compare the analgesic effect of 2 mA anodal direct current stimulation on the right primary motor cortex (M1) (tDCS) with a similar stimulation on the spine (D10) (tsDCS) in healthy volunteers (HV) followed by a pilot study in patients suffering of endometriosis-related chronic pelvic pain (CPP)

Detailed description

\- 2 groups of 5 HV will receive tDCS or tsDCS (2mA, anodal, 20min) and the thermonociceptive threshold will be measured before and after the stimulation over the abdomen (hypogastric). The HAD scale and SF-36 will also be tested. The treatment(s) that produces the greatest increase in pain thresholds will be chosen to treat 10 patients. \- 10 patients suffering from endometriosis-related chronic pelvic pain will be treated by the most efficient treatment (tDCS or tsDCS) for 4 weeks (5 daily 20-min sessions per week), or, if no treatment modality was superior in HV, 5 patients will be treated by tDCS and 5 by tsDCS. Patients will fill in daily a dedicated diary 2 weeks before treatment, during the4-week treatment period and after this period as long as their pain level remains below 80% of their baseline pain intensity (VAS). Analgesic intake will also be monitored as well as HAD and SF-36 scores.

Conditions

• Endometriosis
• Pelvic Pain
• Transcranial Direct Current Stimulation
• Spinal Cord Stimulation

Interventions

Type	Name	Description
DEVICE	Transcranial DCS Healthy Volunteers	The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the right primary motor cortex of healthy volunteers
DEVICE	Transspinal DCS Healthy Volunteers	The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of healthy volunteers
DEVICE	Transcranial DCS CPP patients	The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the right primary motor cortex of CPP patients
DEVICE	Transspinal DCS CPP patients	The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of CPP patients

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-11-01
• Completion: 2018-01-01
• First posted: 2016-11-08
• Last updated: 2016-11-08

Locations

1 site across 1 country: Belgium