tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment

Study Overview
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Brief Summary
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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
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- 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.

Official Title
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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

Conditions
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Pelvic Pain, Endometriosis, Transcranial Direct Current Stimulation, Spinal Cord Stimulation

Intervention / Treatment
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* Device: Transcranial DCS Healthy Volunteers
* Device: Transspinal DCS Healthy Volunteers
* Device: Transcranial DCS CPP patients
* Device: Transspinal DCS CPP patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HV: good health. CPP patients: surgical diagnosis of endometriosis within the last 10 years; diagnosis of chronic pelvic pain (according to ACOG); mean VAS pain score >4 during severe episodes. Exclusion Criteria: HV: chronic pain disorder; no regular medication or illicit drug use. CPP patients: pregnancy; other medical or psychiatric condition interfering with pelvic pain assessment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial DCS Healthy Volunteers<br>5 HV will be treated once with transcranial direct current stimulation (2mA, anodal, 20 minutes) over right primary motor cortex with the Direct Current (DC) Stimulator (NeuroConn. Germany) | Device: Transcranial DCS Healthy Volunteers<br>* 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<br>|
| Experimental: Transspinal DCS Healthy Volunteers<br>5 HV will be treated once with transspinal direct current stimulation (2mA, anodal, 20 minutes) over the D10 spinal process with the Direct Current (DC) Stimulator (NeuroConn. Germany) | Device: Transspinal DCS Healthy Volunteers<br>* The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of healthy volunteers<br>|
| Experimental: Transcranial DCS CPP patients<br>5 chronic pelvic pain patients will be treated with transcranial direct current stimulation (2mA, anodal, 20 minutes) over right primary motor cortex 5 days/week for 4 weeks with the Direct Current (DC) Stimulator (NeuroConn. Germany) | Device: Transcranial DCS CPP patients<br>* 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<br>|
| Experimental: Transspinal DCS CPP patients<br>5 chronic pelvic pain patients will be treated with transspinal direct current stimulation (2mA, anodal, 20 minutes) over the D10 spinal process 5 days/week for 4 weeks with the Direct Current (DC) Stimulator (NeuroConn. Germany) | Device: Transspinal DCS CPP patients<br>* The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of CPP patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antalgic effect of direct current stimulation by measuring Quantitative Sensory Testing (QST) |  | 30 minutes |