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

Not Applicable

Recruiting

• Conditions: Anhedonia
• Interventions: Device: sham tDCS; Device: active tDCS

• Registration Number: NCT05240352
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-15
• Study Start: 2022-10-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham tDCS	sham tDCS	-
active tDCS	active tDCS	-

Primary Outcome Measures

Name	Time	Method
change in the fractional anisotropy of the uncinate fasciculus	baseline, 6 weeks	Change in the fractional anisotropy of the uncinate fasciculus as assessed by diffusion tensor imaging (DTI)

Secondary Outcome Measures

Name	Time	Method
changes in symptoms of anhedonia as assessed by the Snaith-Hamilton Pleasure Scale modified for clinical administration (SHAPS-C)	baseline, 6 weeks	This is a 14 item questionnaire and each is scored from 1 to 4 (1 = Lots of pleasure, 4 = No pleasure)
change in symptoms of anticipatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)	baseline, 6 weeks	The TEPS presents 18 items, 10 of them related to the experience of anticipatory pleasure, and the other 8 related to the ability to experience pleasure at the moment. This is scored on a 6-point Likert scale (1 = very false for me to 6 = very true for me).Total scores vary form 18-108 and lower scores mean higher anhedonia
change in symptoms of consummatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)	baseline, 6 weeks	The TEPS presents 18 items, 10 of them related to the experience of anticipatory pleasure, and the other 8 related to the ability to experience pleasure at the moment. This is scored on a 6-point Likert scale (1 = very false for me to 6 = very true for me).Total scores vary form 18-108 and lower scores mean higher anhedonia

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States