EndometriosisPhase 1/2DCSErCPPNCT02958423
tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment
A Phase 1/2 study testing Transcranial DCS Healthy Volunteers, Transspinal DCS Healthy Volunteers and Transcranial DCS CPP patients in people with Endometriosis and Pelvic Pain, run by Jean Schoenen at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Pelvic Pain, Transcranial Direct Current Stimulation
- What is being tested?
- Transcranial DCS Healthy Volunteers, Transspinal DCS Healthy Volunteers and Transcranial DCS CPP patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2016to Jan 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- HV: chronic pain disorder; no regular medication or illicit drug use.
- CPP patients: pregnancy; other medical or psychiatric condition interfering with pelvic pain assessment.
Trial locations and contacts
1 site in 1 country.
Jean Schoenen, Professor contact
Belgium1 site, 1 recruiting
- Recruiting
Departments of Gynecology & Neurology. CHR Citadelle
Liège, 4000
Jean Schoenen, MD, PhD, +3242238663, jschoenen@ulg.ac.be
Michel Fataki Likale, MD, +3242256111, mfataki@student.ulg.ac.be
About this study
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
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)
Read the 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.
- Conditions
- Endometriosis, Pelvic Pain, Transcranial Direct Current Stimulation, Spinal Cord Stimulation
- Being tested
- Transcranial DCS Healthy Volunteers, Transspinal DCS Healthy Volunteers, Transcranial DCS CPP patients, Transspinal DCS CPP patients
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial DCS Healthy VolunteersDevice
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 VolunteersDevice
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 patientsDevice
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 patientsDevice
The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of CPP patients
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Device: Transspinal DCS CPP patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antalgic effect of direct current stimulation by measuring Quantitative Sensory Testing (QST)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jean Schoenen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean Schoenen, University of Liege
- Investigators
- Michelle Nisolle, Professor, Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958423
- Sponsor's protocol ID
- B412201524615
- Acronym
- DCSErCPP
- Status last verified
- Nov 2016
- First submitted
- 1 Nov 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: anonymized data will be made available on request via e-mail
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02958423
- Acronym / sponsor ID
- DCSErCPP / B412201524615
- Conditions
- Endometriosis, Pelvic Pain, Transcranial Direct Current Stimulation, Spinal Cord Stimulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jean SchoenenUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transcranial DCS Healthy Volunteers | Experimental | Device: Transcranial DCS Healthy Volunteers5 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) |
| Transspinal DCS Healthy Volunteers | Experimental | Device: Transspinal DCS Healthy Volunteers5 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) |
| Transcranial DCS CPP patients | Experimental | Device: Transcranial DCS CPP patients5 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) |
| Transspinal DCS CPP patients | Experimental | Device: Transspinal DCS CPP patients5 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- HV: chronic pain disorder; no regular medication or illicit drug use.
- CPP patients: pregnancy; other medical or psychiatric condition interfering with pelvic pain assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial DCS Healthy VolunteersThe DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the right primary motor cortex of healthy volunteers | Device | Transcranial DCS Healthy Volunteers |
| Transspinal DCS Healthy VolunteersThe DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of healthy volunteers | Device | Transspinal DCS Healthy Volunteers |
| Transcranial DCS CPP patientsThe DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the right primary motor cortex of CPP patients | Device | Transcranial DCS CPP patients |
| Transspinal DCS CPP patientsThe DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of CPP patients | Device | Transspinal DCS CPP patients |
Primary outcome
Antalgic effect of direct current stimulation by measuring Quantitative Sensory Testing (QST)
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Individual participant dataSharing planned: Yes. anonymized data will be made available on request via e-mail
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Schoenen, Professor contact
Michelle Nisolle, Professor principal investigator
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcranial DCS Healthy Volunteers, Transspinal DCS Healthy Volunteers and Transcranial DCS CPP patients in people with Endometriosis and Pelvic Pain, run by Jean Schoenen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Fataki Likale, Intern (0032496721921, m.fataki@student.ulg.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antalgic effect of direct current stimulation by measuring Quantitative Sensory Testing (QST) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.