NCT05240352 Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients With Bipolar Depression
| NCT ID | NCT05240352 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Anhedonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2022-10-06 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2022-10-06 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to investigate whether transcranial direct-current stimulation (tDCS) will engage reward-related brain circuitry, more specifically the uncinate fasciculus (UF) tract, which connects the orbitofrontal cortex (OFC) and nucleus accumbens (NAcc) regions. Also to evaluate whether the changes in the fractional anisotropy (FA) of the UF tract are associated with changes of clinical symptoms of anhedonia and finally to investigate the moderation role of simulated electric fields (EFs) in an association between FA of the UF and symptoms of anhedonia.
Eligibility Criteria
Inclusion Criteria: * diagnosis of Bipolar Disorder and clinically significant anhedonia * mild symptoms of depression Exclusion Criteria: * substance abuse/dependence and any use of drugs (except alcohol or nicotine) in the previous month of the baseline assessment * participants with personality disorder that would interfere with study participation according to clinical judgment * previous neurological conditions (epilepsy, traumatic brain injury, stroke, etc) * any severe, life-threatening non-psychiatric medical condition * specific contraindications for tDCS (metallic plates in the head) * Participants identified as acutely suicidal or severely agitated
Contact & Investigator
Jair C Soares, MD,PhD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT05240352 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Anhedonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05240352 currently recruiting?
Yes, NCT05240352 is actively recruiting participants. Contact the research team at UTMoodDisorders@uth.tmc.edu for enrollment information.
Where is the NCT05240352 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05240352 clinical trial?
NCT05240352 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Jair C Soares, MD,PhD at The University of Texas Health Science Center, Houston. The trial plans to enroll 45 participants.