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NCT Number: NCT05240352

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. change in the fractional anisotropy of the uncinate fasciculus

    Time frame: baseline, 6 weeks

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

Secondary outcomes

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

    Time frame: baseline, 6 weeks

    This is a 14 item questionnaire and each is scored from 1 to 4 (1 = Lots of pleasure, 4 = No pleasure)

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

    Time frame: 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

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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandre P Diaz, MD,PhD

CONTACT

[email protected]

(713) 486-6663

Jair C Soares, MD,PhD

CONTACT

[email protected]

(713) 486-6663

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Milken Institute

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2022
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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