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Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients With Bipolar Depression

NCT05240352 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

  • Anhedonia

Interventions

DEVICE

active tDCS

Subjects will receive active dose (constant current intensity of 2mA) from the tDCS device for 30 minutes per session for two weeks with no sessions on Saturday and Sunday (Monday to Friday), and one additional session two and four weeks later

DEVICE

sham tDCS

Subjects will receive a dose from a "sham-tDCS"that is, a device which delivers a different pattern of electric current for 30 minutes per session for two weeks with no sessions on Saturday and Sunday (Monday to Friday), and one additional session two and four weeks later

Sponsors & Collaborators

  • Milken Institute

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Jair C Soares, MD,PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-06
Primary Completion
2026-12-01
Completion
2026-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05240352 on ClinicalTrials.gov