NCT05231239

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

January 28, 2022

Last Update Submit

February 8, 2022

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Pelvic pain via pressure pain threshold

    pressure pain threshold

    4 weeks

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

tDCS will be applied for 20 min with 2 mA

Device: tDCS : Transcranial direct current stimulation

Placebo tDCS

PLACEBO COMPARATOR

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

Device: tDCS : Transcranial direct current stimulation

Interventions

tDCS : Transcranial direct current stimulationDEVICE

Transcranial direct current stimulation

Active tDCSPlacebo tDCS

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University Medicine

Berlin, 12200, Germany

RECRUITING

Related Publications (1)

  • Mechsner S, Grunert J, Wiese JJ, Vormbaumen J, Sehouli J, Siegmund B, Neeb L, Pruss MS. Transcranial direct current stimulation to reduce chronic pelvic pain in endometriosis: phase II randomized controlled clinical trial. Pain Med. 2023 Jul 5;24(7):809-817. doi: 10.1093/pm/pnad031.

    PMID: 36882181DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Magdalena S Prüß, MD

    Charite University Medicine Berlin, Germany, 12200

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena S Prüß, MD

CONTACT

+493084452711magdalena.pruess@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator ; PD Dr. med.

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 9, 2022

Study Start

January 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

February 9, 2022

Record last verified: 2022-02

Locations

DE(1)