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

NCT05240352 | Recruiting FDA Device

• 1 other identifier: HSC-MS-21-1044
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

bipolar depression

Outcome Measures

Primary Outcomes (1)

• change in the fractional anisotropy of the uncinate fasciculus

  Change in the fractional anisotropy of the uncinate fasciculus as assessed by diffusion tensor imaging (DTI)

  baseline, 6 weeks

Secondary Outcomes (3)

• changes in symptoms of anhedonia as assessed by the Snaith-Hamilton Pleasure Scale modified for clinical administration (SHAPS-C)

  baseline, 6 weeks

• change in symptoms of anticipatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)

  baseline, 6 weeks

• change in symptoms of consummatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)

  baseline, 6 weeks

Study Arms (2)

active tDCS

EXPERIMENTAL

Device: active tDCS

sham tDCS

SHAM COMPARATOR

Device: sham tDCS

Interventions

active tDCS DEVICE

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

active tDCS

sham tDCS DEVICE

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

sham tDCS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of Bipolar Disorder and clinically significant anhedonia
• mild symptoms of depression

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Milken Institute: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Anhedonia; Bipolar Disorder

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Jair C Soares, MD,PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jair C Soares, MD,PhD

CONTACT

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

Alexandre P Diaz, MD,PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: October 6, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)