EndometriosisPhase 2NCT05231239
Transcranial Direct Current Stimulation to Reduce Chronic Pelvic Pain in Endometriosis
A Phase 2 study testing tDCS : Transcranial direct current stimulation in people with Endometriosis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- tDCS : Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2021to Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Endometriosis Chronic pain (more than 3 months) Pain (VAS > 3/10)
Who cannot join
- Contraindication to transcranial direct current stimulation Pregnancy Sever internal or psychiatric condition
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite University Medicine
Berlin, 12200
Magdalena S Prüß-Volz, MD, +493084452718, magdalena.pruess@charite.de
About this study
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.
- Conditions
- Endometriosis
- Being tested
- tDCS : Transcranial direct current stimulation
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS : Transcranial direct current stimulationDevice
Transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | tDCS will be applied for 20 min with 2 mA Receives: 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 Receives: Device: tDCS : Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic pain via pressure pain threshold
pressure pain threshold
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Jan 2021
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena S. Prüß née Volz, Charite University, Berlin, Germany
- Investigators
- Magdalena S Prüß, MD, Principal investigator, Charite University Medicine Berlin, Germany, 12200
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231239
- Sponsor's protocol ID
- EA1/174/19
- Status last verified
- Feb 2022
- First submitted
- 28 Jan 2022
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36882181
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation to Reduce Chronic Pelvic Pain in Endometriosis
- ClinicalTrials.gov ID
- NCT05231239
- Acronym / sponsor ID
- EA1/174/19
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: tDCS : Transcranial direct current stimulationtDCS will be applied for 20 min with 2 mA |
| Placebo tDCS | Placebo comparator | Device: tDCS : Transcranial direct current stimulationtDCS will be applied for only 20 sec, monatge will be left on the head for 20 min |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Endometriosis Chronic pain (more than 3 months) Pain (VAS > 3/10)
Key exclusion criteria (1 listed)
- Contraindication to transcranial direct current stimulation Pregnancy Sever internal or psychiatric condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS : Transcranial direct current stimulationTranscranial direct current stimulation | Device | Active tDCS, Placebo tDCS |
Primary outcome
Pelvic pain via pressure pain threshold
Time frame: 4 weeks
pressure pain threshold
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Derived from this study: PubMed 36882181Mechsner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena S Prüß, MD principal investigator
Charite University Medicine Berlin, Germany, 12200
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tDCS : Transcranial direct current stimulation in people with Endometriosis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magdalena S Prüß, MD (+493084452711, magdalena.pruess@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic pain via pressure pain threshold (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05231239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.