Transcranial Direct Current Stimulation to Reduce Chronic Pelvic Pain in Endometriosis

NCT ID: NCT05231239

Last Updated: 2022-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active tDCS

tDCS will be applied for 20 min with 2 mA

Group Type ACTIVE_COMPARATOR

tDCS : Transcranial direct current stimulation

Intervention Type DEVICE

Transcranial direct current stimulation

Placebo tDCS

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

Group Type PLACEBO_COMPARATOR

tDCS : Transcranial direct current stimulation

Intervention Type DEVICE

Transcranial direct current stimulation

Interventions

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tDCS : Transcranial direct current stimulation

Transcranial direct current stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Magdalena S. Prüß née Volz

Principal Investigator ; PD Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magdalena S Prüß, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University Medicine Berlin, Germany, 12200

Locations

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Charite University Medicine

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Magdalena S Prüß, MD

Role: CONTACT

+493084452711

Facility Contacts

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Magdalena S Prüß-Volz, MD

Role: primary

+493084452718

References

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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.

Reference Type DERIVED
PMID: 36882181 (View on PubMed)

Other Identifiers

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EA1/174/19

Identifier Type: -

Identifier Source: org_study_id

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