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Transcranial Direct Current Stimulation to Reduce Chronic Pelvic Pain in Endometriosis

Primary Purpose

Endometriosis

Status
Recruiting
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
tDCS : Transcranial direct current stimulation
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Endometriosis Chronic pain (more than 3 months) Pain (VAS > 3/10)

Exclusion Criteria:

- Contraindication to transcranial direct current stimulation Pregnancy Sever internal or psychiatric condition

Sites / Locations

  • Charite University MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active tDCS

Placebo tDCS

Arm Description

tDCS will be applied for 20 min with 2 mA

tDCS will be applied for only 20 sec, monatge will be left on the head for 20 min

Outcomes

Primary Outcome Measures

Pelvic pain via pressure pain threshold
pressure pain threshold

Secondary Outcome Measures

Full Information

First Posted
January 28, 2022
Last Updated
February 8, 2022
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05231239
Brief Title
Transcranial Direct Current Stimulation to Reduce Chronic Pelvic Pain in Endometriosis
Official Title
Transcranial Direct Current Stimulation to Reduce Chronic Pelvic Pain in Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In the study it will be tested whether transcranial direct current stimulation can reduce the perception of pelvic pain in patients with endometriosis. Hypothesis: Transcranial direct current stimulation can reduce the perception of pelvic pain in patients with patients with endometriosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Active Comparator
Arm Description
tDCS will be applied for 20 min with 2 mA
Arm Title
Placebo tDCS
Arm Type
Placebo Comparator
Arm Description
tDCS will be applied for only 20 sec, monatge will be left on the head for 20 min
Intervention Type
Device
Intervention Name(s)
tDCS : Transcranial direct current stimulation
Intervention Description
Transcranial direct current stimulation
Primary Outcome Measure Information:
Title
Pelvic pain via pressure pain threshold
Description
pressure pain threshold
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Endometriosis Chronic pain (more than 3 months) Pain (VAS > 3/10) Exclusion Criteria: - Contraindication to transcranial direct current stimulation Pregnancy Sever internal or psychiatric condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magdalena S Prüß, MD
Phone
+493084452711
Email
magdalena.pruess@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena S Prüß, MD
Organizational Affiliation
Charite University Medicine Berlin, Germany, 12200
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite University Medicine
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena S Prüß-Volz, MD
Phone
+493084452718
Email
magdalena.pruess@charite.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Transcranial Direct Current Stimulation to Reduce Chronic Pelvic Pain in Endometriosis

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