Actively Recruiting
Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients With Bipolar Depression
Led by The University of Texas Health Science Center, Houston · Updated on 2026-02-18
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
M
Milken Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether transcranial direct-current stimulation (tDCS) can engage brain areas related to reward, focusing on the uncinate fasciculus tract connecting the orbitofrontal cortex and nucleus accumbens. The study aims to see if changes in brain structure measured by fractional anisotropy relate to changes in symptoms of anhedonia in people with bipolar depression. It also explores how simulated electric fields may influence this relationship. Participants will be randomly assigned to receive either active tDCS or sham tDCS. Active tDCS involves a constant current of 2mA applied for 30 minutes per session on weekdays for two weeks, plus one session each at two and four weeks later. The sham group receives a different current pattern mimicking the treatment schedule. This double-blind design helps compare effects while maintaining study objectivity. During the study, participants will be assessed at baseline and six weeks for changes in brain structure and clinical symptoms of anhedonia using specific scales. The primary outcome is the change in fractional anisotropy of the uncinate fasciculus. Secondary outcomes include changes in anticipatory and consummatory anhedonia symptoms. Safety and symptom monitoring will occur throughout the study, which is expected to end in December 2026.
CONDITIONS
Brief Title
Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients With Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Bipolar Disorder with clinically significant anhedonia
- Mild symptoms of depression
- Age between 18 and 50 years
You will not qualify if you...
- Substance abuse or dependence and any drug use (except alcohol or nicotine) within one month before baseline
- Personality disorder that interferes with study participation
- Previous neurological conditions such as epilepsy, traumatic brain injury, or stroke
- Severe, life-threatening non-psychiatric medical conditions
- Presence of metallic plates in the head
- Being acutely suicidal or severely agitated
- Any specific contraindications for transcranial direct-current stimulation (tDCS)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Two weeks with additional sessions at Week 2 and Week 4
Participants receive active or sham transcranial direct current stimulation (tDCS) sessions for 30 minutes each. Sessions occur Monday to Friday for two weeks, with no sessions on weekends, plus one additional session at two weeks and one at four weeks after initial treatment.
Monday to Friday sessions for two weeks, plus one session at Week 2 and one session at Week 4
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jair C Soares, MD,PhD
A
Alexandre P Diaz, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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