tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment

NCT02958423 | Unknown Phase 1

• 1 other identifier: B412201524615
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Antalgic effect of direct current stimulation by measuring Quantitative Sensory Testing (QST)

  30 minutes

Study Arms (4)

Transcranial DCS Healthy Volunteers

EXPERIMENTAL

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

Transspinal DCS Healthy Volunteers

EXPERIMENTAL

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

Transcranial DCS CPP patients

EXPERIMENTAL

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

Transspinal DCS CPP patients

EXPERIMENTAL

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

Interventions

Transcranial DCS Healthy Volunteers DEVICE

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

Transcranial DCS Healthy Volunteers

Transspinal DCS Healthy Volunteers DEVICE

The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of healthy volunteers

Transspinal DCS Healthy Volunteers

Transcranial DCS CPP patients DEVICE

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

Transcranial DCS CPP patients

Transspinal DCS CPP patients DEVICE

The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of CPP patients

Transspinal DCS CPP patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• HV: chronic pain disorder; no regular medication or illicit drug use.
• CPP patients: pregnancy; other medical or psychiatric condition interfering with pelvic pain assessment.

Sponsors & Collaborators

• Jean Schoenen: lead

Study Sites (1)

Departments of Gynecology & Neurology. CHR Citadelle

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Nisolle, Professor

  University of Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Fataki Likale, Intern

CONTACT

0032496721921; m.fataki@student.ulg.ac.be

Jean Schoenen, Professor

CONTACT

jschoenen@ulg.ac.be

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 8, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: January 1, 2018
• Last Updated: November 8, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)