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

Plain Language Summary

Simplified for easier understanding

This study uses brain imaging and a mild form of brain stimulation (transcranial direct current stimulation, or tDCS) to help personalize treatment for people with bipolar disorder who experience a persistent lack of pleasure or motivation — called anhedonia — even when depression symptoms are mild. **You may be eligible if...** - You have been diagnosed with bipolar disorder - You are experiencing significant anhedonia (lack of enjoyment or motivation) - Your depression symptoms are currently mild **You may NOT be eligible if...** - You have used illicit drugs (other than alcohol or nicotine) in the past month - You have a personality disorder that would interfere with participation - You have a history of epilepsy, traumatic brain injury, or stroke - You have a life-threatening non-psychiatric illness - You have metal plates in your head (which would interfere with tDCS) - You are currently suicidal or severely agitated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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