tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment
NCT ID: NCT02958423
Last Updated: 2016-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2016-11-30
2018-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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)
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
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)
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
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)
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
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)
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
Interventions
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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
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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* CPP patients: pregnancy; other medical or psychiatric condition interfering with pelvic pain assessment.
18 Years
50 Years
FEMALE
Yes
Sponsors
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Jean Schoenen
OTHER
Responsible Party
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Jean Schoenen
Professor
Principal Investigators
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Michelle Nisolle, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Liege
Locations
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Departments of Gynecology & Neurology. CHR Citadelle
Liège, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Jean Schoenen, MD, PhD
Role: primary
Michel Fataki Likale, MD
Role: backup
Other Identifiers
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B412201524615
Identifier Type: -
Identifier Source: org_study_id