Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients With Bipolar Depression
Primary Purpose
Anhedonia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
active tDCS
sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Anhedonia focused on measuring bipolar depression
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
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
active tDCS
sham tDCS
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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
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
Full Information
NCT ID
NCT05240352
First Posted
February 4, 2022
Last Updated
August 4, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Milken Institute
1. Study Identification
Unique Protocol Identification Number
NCT05240352
Brief Title
Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients With Bipolar Depression
Official Title
Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients With Bipolar Depression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Milken Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anhedonia
Keywords
bipolar depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active tDCS
Arm Type
Experimental
Arm Title
sham tDCS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
active tDCS
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
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 Measure Information:
Title
change in the fractional anisotropy of the uncinate fasciculus
Description
Change in the fractional anisotropy of the uncinate fasciculus as assessed by diffusion tensor imaging (DTI)
Time Frame
baseline, 6 weeks
Secondary Outcome Measure Information:
Title
changes in symptoms of anhedonia as assessed by the Snaith-Hamilton Pleasure Scale modified for clinical administration (SHAPS-C)
Description
This is a 14 item questionnaire and each is scored from 1 to 4 (1 = Lots of pleasure, 4 = No pleasure)
Time Frame
baseline, 6 weeks
Title
change in symptoms of anticipatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)
Description
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
Time Frame
baseline, 6 weeks
Title
change in symptoms of consummatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)
Description
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
Time Frame
baseline, 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jair C Soares, MD,PhD
Phone
(713) 486-2507
Email
Jair.C.Soares@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre P Diaz, MD,PhD
Phone
(713) 486-2700
Email
Alexandre.PaimDiaz@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jair C Soares, MD,PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jair C Soares, MD,PhD
Phone
713-486-2507
Email
Jair.C.Soares@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Alexandre P Diaz, MD,PhD
Phone
(713) 486-2700
Email
Alexandre.PaimDiaz@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients With Bipolar Depression
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