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

Primary Purpose

Endometriosis, Pelvic Pain, Transcranial Direct Current Stimulation

Status
Unknown status
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Transcranial DCS Healthy Volunteers
Transspinal DCS Healthy Volunteers
Transcranial DCS CPP patients
Transspinal DCS CPP patients
Sponsored by
Jean Schoenen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Departments of Gynecology & Neurology. CHR CitadelleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Transcranial DCS Healthy Volunteers

Transspinal DCS Healthy Volunteers

Transcranial DCS CPP patients

Transspinal DCS CPP patients

Arm Description

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)

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)

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 1, 2016
Last Updated
November 4, 2016
Sponsor
Jean Schoenen
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1. Study Identification

Unique Protocol Identification Number
NCT02958423
Brief Title
tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment
Acronym
DCSErCPP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jean Schoenen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Pelvic Pain, Transcranial Direct Current Stimulation, Spinal Cord Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial DCS Healthy Volunteers
Arm Type
Experimental
Arm Description
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)
Arm Title
Transspinal DCS Healthy Volunteers
Arm Type
Experimental
Arm Description
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)
Arm Title
Transcranial DCS CPP patients
Arm Type
Experimental
Arm Description
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)
Arm Title
Transspinal DCS CPP patients
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Transcranial DCS Healthy Volunteers
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Transspinal DCS Healthy Volunteers
Intervention Description
The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of healthy volunteers
Intervention Type
Device
Intervention Name(s)
Transcranial DCS CPP patients
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Transspinal DCS CPP patients
Intervention Description
The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of CPP patients
Primary Outcome Measure Information:
Title
Antalgic effect of direct current stimulation by measuring Quantitative Sensory Testing (QST)
Time Frame
30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel Fataki Likale, Intern
Phone
0032496721921
Email
m.fataki@student.ulg.ac.be
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Schoenen, Professor
Email
jschoenen@ulg.ac.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Nisolle, Professor
Organizational Affiliation
University of Liege
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departments of Gynecology & Neurology. CHR Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Schoenen, MD, PhD
Phone
+3242238663
Email
jschoenen@ulg.ac.be
First Name & Middle Initial & Last Name & Degree
Michel Fataki Likale, MD
Phone
+3242256111
Email
mfataki@student.ulg.ac.be
First Name & Middle Initial & Last Name & Degree
Michelle Nisolle, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
anonymized data will be made available on request via e-mail

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tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment

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