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

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ClinicalTrials.gov Identifier: NCT02958423
Recruitment Status : Unknown
Verified November 2016 by Jean Schoenen, University of Liege.
Recruitment status was:  Recruiting
First Posted : November 8, 2016
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Jean Schoenen, University of Liege

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)

Condition or disease Intervention/treatment Phase
Endometriosis Pelvic Pain Transcranial Direct Current Stimulation Spinal Cord Stimulation Device: Transcranial DCS Healthy Volunteers Device: Transspinal DCS Healthy Volunteers Device: Transcranial DCS CPP patients Device: Transspinal DCS CPP patients Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : November 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Antalgic effect of direct current stimulation by measuring Quantitative Sensory Testing (QST) [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958423


Contacts
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Contact: Michel Fataki Likale, Intern 0032496721921 m.fataki@student.ulg.ac.be
Contact: Jean Schoenen, Professor jschoenen@ulg.ac.be

Locations
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Belgium
Departments of Gynecology & Neurology. CHR Citadelle Recruiting
Liege, Belgium, 4000
Contact: Jean Schoenen, MD, PhD    +3242238663    jschoenen@ulg.ac.be   
Contact: Michel Fataki Likale, MD    +3242256111    mfataki@student.ulg.ac.be   
Principal Investigator: Michelle Nisolle, MD, PhD         
Sponsors and Collaborators
Jean Schoenen
Investigators
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Principal Investigator: Michelle Nisolle, Professor University of Liege
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Responsible Party: Jean Schoenen, Professor, University of Liege
ClinicalTrials.gov Identifier: NCT02958423    
Other Study ID Numbers: B412201524615
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: anonymized data will be made available on request via e-mail
Additional relevant MeSH terms:
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Endometriosis
Pelvic Pain
Pain
Neurologic Manifestations
6-chloro-2-(1-piperazinyl)pyrazine
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs