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 (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05240352
• Collaborator: Milken Institute (Other)
• Enrollment: 45
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anhedonia	Device: active tDCS; Device: sham tDCS	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients With Bipolar Depression
• Anticipated Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: active tDCS	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 Comparator: sham tDCS	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

Outcome Measures

Primary Outcome Measures

1. change in the fractional anisotropy of the uncinate fasciculus [baseline, 6 weeks]

   Change in the fractional anisotropy of the uncinate fasciculus as assessed by diffusion tensor imaging (DTI)

Secondary Outcome Measures

1. changes in symptoms of anhedonia as assessed by the Snaith-Hamilton Pleasure Scale modified for clinical administration (SHAPS-C) [baseline, 6 weeks]

   This is a 14 item questionnaire and each is scored from 1 to 4 (1 = Lots of pleasure, 4 = No pleasure)

2. change in symptoms of anticipatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS) [baseline, 6 weeks]

   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

3. change in symptoms of consummatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS) [baseline, 6 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston
• Milken Institute

Investigators

• Principal Investigator: Jair C Soares, MD,PhD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jair Soares, Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT05240352
• Other Study ID Numbers: HSC-MS-21-1044
• First Posted: Feb 15, 2022
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Jair Soares, Professor, The University of Texas Health Science Center, Houston: bipolar depression
• Additional relevant MeSH terms: Anhedonia; Depression; Bipolar Disorder

Study Results

No Results Posted as of Feb 15, 2022