tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02958423

Acronym

DCSErCPP

Enrollment

Registered

2016-11-08

Start date

2016-11-30

Completion date

2018-01-31

Last updated

2016-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis, Pelvic Pain, Spinal Cord Stimulation, Transcranial Direct Current Stimulation

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.

Interventions

DEVICETranscranial 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

DEVICETransspinal 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

DEVICETranscranial 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

DEVICETransspinal 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Belgium

Contacts

Primary ContactMichel Fataki Likale, Intern

m.fataki@student.ulg.ac.be0032496721921

Backup ContactJean Schoenen, Professor

jschoenen@ulg.ac.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026