tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment (DCSErCPP)

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

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)

Study Overview

• Status: Unknown
• Conditions: Endometriosis; Pelvic Pain; Transcranial Direct Current Stimulation; Spinal Cord Stimulation
• Intervention / Treatment: Device: Transcranial DCS Healthy Volunteers; Device: Transspinal DCS Healthy Volunteers; Device: Transcranial DCS CPP patients; Device: Transspinal DCS CPP patients

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Michel Fataki Likale, Intern; Phone Number: 0032496721921; Email: m.fataki@student.ulg.ac.be
• Study Contact Backup: Name: Jean Schoenen, Professor; Email: jschoenen@ulg.ac.be

Study Locations

• Belgium
  • Liege, Belgium, 4000
    • Recruiting
    • Departments of Gynecology & Neurology. CHR Citadelle
    • Contact: Michel Fataki Likale, MD; Phone Number: +3242256111; Email: mfataki@student.ulg.ac.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial DCS Healthy Volunteers; 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; 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
Experimental: Transspinal DCS Healthy Volunteers; 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; The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of healthy volunteers
Experimental: Transcranial DCS CPP patients; 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; 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
Experimental: Transspinal DCS CPP patients; 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; The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of CPP patients

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jean Schoenen
• Investigators: Principal Investigator: Michelle Nisolle, Professor, University of Liège

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Estimate): November 8, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endometriosis; Pelvic Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; 6-chloro-2-(1-piperazinyl)pyrazine
• Other Study ID Numbers: B412201524615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: anonymized data will be made available on request via e-mail