RecruitingNot ApplicableNCT05240352

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

45 participants

Start Date

Oct 6, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria2

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

Exclusion Criteria6

  • 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

Interventions

DEVICEactive 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

DEVICEsham 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


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT05240352


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