Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients With Bipolar Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: active tDCS, sham tDCS.
- Who it may be relevant to
- Registry conditions: Anhedonia. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device active 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 - Device sham 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
Primary outcome measures
- change in the fractional anisotropy of the uncinate fasciculus [Time frame: baseline, 6 weeks]
Secondary outcome measures (3)
- changes in symptoms of anhedonia as assessed by the Snaith-Hamilton Pleasure Scale modified for clinical administration (SHAPS-C) [Time frame: baseline, 6 weeks]
- change in symptoms of anticipatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS) [Time frame: baseline, 6 weeks]
- change in symptoms of consummatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS) [Time frame: baseline, 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT05240352 · HSC-MS-21-1044