tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment

Endometriosis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02958423
• Other study ID #: B412201524615
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 1, 2016
• Last updated: November 4, 2016
• Start date: November 2016
• Est. completion date: January 2018

Study information

• Verified date: November 2016
• Source: University Hospital of Liege
• Contact: Michel Fataki Likale, Intern
• Phone: 0032496721921
• Email: m.fataki[@]student.ulg.ac.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical 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 pain (CPP)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
Belgium	Departments of Gynecology & Neurology. CHR Citadelle	Liege

Sponsors (1)

Lead Sponsor	Collaborator
Jean Schoenen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antalgic effect of direct current stimulation by measuring Quantitative Sensory Testing (QST)		30 minutes	No