Recruiting

Transcranial Electric Stimulation

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05240352

Conditions

Anhedonia

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

active tDCS

sham tDCS

Study Details

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.

Conditions

Anhedonia

Study ID

NCT05240352

Start date

Oct 6, 2022

Status verified date

Feb, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: active tDCS

sham comparator: sham tDCS

Interventions

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

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

Primary outcome measure

  • change in the fractional anisotropy of the uncinate fasciculus [ Time Frame: baseline, 6 weeks ]

Central Contacts and Locations

Central contacts

Jair C Soares, MD,PhD

(713) 486-6663UTMoodDisorders@uth.tmc.edu

Alexandre P Diaz, MD,PhD

(713) 486-6663UTMoodDisorders@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Jair C Soares, MD,PhD

(713) 486-6663UTMoodDisorders@uth.tmc.edu

Lara Karatas, BS, BA

(713) 486-6663UTMoodDisorders@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • bipolar depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-02-18.