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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Enrolling

Conditions

Anhedonia

Treatments

Device: sham tDCS
Device: active tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT05240352
HSC-MS-21-1044

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 2 patient groups

active tDCS
Experimental group
Treatment:
Device: active tDCS
sham tDCS
Sham Comparator group
Treatment:
Device: sham tDCS

Trial contacts and locations

1

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Central trial contact

Jair C Soares, MD,PhD; Alexandre P Diaz, MD,PhD

Data sourced from clinicaltrials.gov

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