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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anhedonia

Intervention / Treatment
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* Device: active tDCS
* Device: sham tDCS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active tDCS<br> | Device: active tDCS<br>* 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<br>|
| Sham Comparator: sham tDCS<br> | Device: sham tDCS<br>* Subjects will receive a dose from a sham-tDCSthat 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the fractional anisotropy of the uncinate fasciculus | Change in the fractional anisotropy of the uncinate fasciculus as assessed by diffusion tensor imaging (DTI) | baseline, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in symptoms of anhedonia as assessed by the Snaith-Hamilton Pleasure Scale modified for clinical administration (SHAPS-C) | This is a 14 item questionnaire and each is scored from 1 to 4 (1 = Lots of pleasure, 4 = No pleasure) | baseline, 6 weeks | 
| change in symptoms of anticipatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS) | 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 | baseline, 6 weeks | 
| change in symptoms of consummatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS) | 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 | baseline, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar depression