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

Anhedonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05240352
• Other study ID #: HSC-MS-21-1044
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Jair C Soares, MD,PhD
• Phone: (713) 486-2507
• Email: Jair.C.Soares[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anhedonia
• Bipolar Disorder
• Depression

Intervention

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
• 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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Milken Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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