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

• Sponsor: Jean Schoenen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02958423
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 4
• Duration (Months): 14
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Nov 1, 2016
• Anticipated Primary Completion Date: Nov 1, 2017
• Anticipated Study Completion Date: Jan 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Antalgic effect of direct current stimulation by measuring Quantitative Sensory Testing (QST) [30 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Departments of Gynecology & Neurology. CHR Citadelle	Liege		Belgium	4000

Sponsors and Collaborators

• Jean Schoenen

Investigators

• Principal Investigator: Michelle Nisolle, Professor, University of Liege

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jean Schoenen, Professor, University of Liege
• ClinicalTrials.gov Identifier: NCT02958423
• Other Study ID Numbers: B412201524615
• First Posted: Nov 8, 2016
• Last Update Posted: Nov 8, 2016
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Endometriosis; Pelvic Pain; 6-chloro-2-(1-piperazinyl)pyrazine

Study Results

No Results Posted as of Nov 8, 2016