NCT06132581 · Florida State University
Causal Role of Delta-beta Coupling for Goal-directed Behavior in Anhedonic Depression
(DBA)
What this study is about
Anhedonia, the inability to seek-out and experience pleasure, is a common symptom in depression that predicts treatment-resistance and is sometimes exacerbated by first-line antidepressants. In our previous research, we found that anhedonia decreases goal-directed behavior and its related neural activity.
View original scientific description
Anhedonia, the inability to seek-out and experience pleasure, is a common symptom in depression that predicts treatment-resistance and is sometimes exacerbated by first-line antidepressants. In our previous research, we found that anhedonia decreases goal-directed behavior and its related neural activity. In this study, we will investigate target engagement from five-consecutive days of stimulation for participants that are within a unipolar major depressive episode and also have high symptoms of anhedonia.
Interventions
DEVICE
Delta-beta tACS via the Neurocare Direct Current Stimulator Multi-Channel 4
Stimulation will be delivered via the Neurocare Direct Current Stimulator Multi-Channel 4, an investigational electrical non-invasive brain stimulation device that is being used for foundational neuroscience and translational research. The electrical waveform for stimulation was designed to mimic delta-beta coupling in the brain.
DEVICE
Theta-gamma tACS via the Neurocare Direct Current Stimulator Multi-Channel 4
Stimulation will be delivered via the Neurocare Direct Current Stimulator Multi-Channel 4, an investigational electrical non-invasive brain stimulation device that is being used for foundational neuroscience and translational research. The electrical waveform for stimulation was designed to mimic theta-gamma coupling in the brain and is used as an active comparator.
DEVICE
Sham tACS via the Neurocare Direct Current Stimulator Multi-Channel 4
Stimulation will be delivered via the Neurocare Direct Current Stimulator Multi-Channel 4, an investigational electrical non-invasive brain stimulation device that is being used for foundational neuroscience and translational research. The electrical waveform is randomly selected to be the theta-gamma or delta-beta waveform, but the stimulation is delivered for only a brief period of time of approximately 30 seconds, which is not sufficient to produce a meaningful dose to the brain. This placebo, or sham, stimulation is designed to mimic the sensation of receiving stimulation.
Primary outcome measures
Change in coupling strength between prefrontal and posterior cortex
Time frame: 1 week
Phase-amplitude coupling strength is calculated between the phase of low-frequency activity in prefrontal electrodes and amplitude of high-frequency in posterior cortex. These signals are extracted from the S-EEfRT during the decision period. Instantaneous phase and amplitude will be calculated by averaging electrodes in the regions, band-filtering to the specified range, and performing the Hilbert transform. Next, a hybrid signal is created using the high-frequency amplitude and low-frequency phase. Coupling strength is the magnitude of the average of this signal over time. Finally, coupling strength is normalized using a z-transformation with respect to a null distribution generated by randomly time-shifting the high-frequency time-series.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Between the ages of 18 and 65
- Able to provide informed consent
- Have normal to corrected vision
- Willing to comply with all study procedures and be available for the duration of the study
- Speak and understand English
- Mild suicide risk as determined by the Hamilton Depression Rating Scale (HAM-D; less than 3 for the suicidality item) and non-existent or mild risk according to the Depression Symptom Index Suicidality Subscale (DSI-SS).
- Patient Health Questionnaire (PHQ-8) greater than or equal to 8 prior to the first session
- Snaith Hamilton Pleasure Scale (SHAPS) greater than 33 at the first session
- A diagnosis of major depressive disorder on the Mini International Neuropsychiatric Interview for the DSM-V (MINI)
Exclusion criteria
- ADHD (currently under treatment)
- Neurological disorders and conditions including, but not limited to history of epilepsy; seizures, except childhood febrile seizures; dementia; history of stroke; Parkinson's disease, multiple sclerosis, cerebral aneurysm; brain tumors
- Medical or neurological illness or treatment for a medical disorder that could interfere with study participation. For example, unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment
- Prior brain surgery
- Any brain devices/implants including cochlear implants and aneurysm clips, cardiac pacemaker, or any other implanted electronic device
- History of current traumatic brain injury
- Pregnancy (for females)
- Current severe substance use disorder
- Claustrophobia
- Based on the use of MRI, additional exclusion/inclusion criteria are considered. Note that many contraindications for stimulation are common with MRI and thus are not repeated. Participants must not have metal in the body that is ferrous, will be required to remove all jewelry, must not have tattoos on the face or neck, must refrain from wearing metal in clothing (underwire) or active gear (possibility of metallic microparticle technology), must not be a metal worker or have an eye injury involving metal.
- Anything that in the opinion of the investigator would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
- DSM-V diagnosis of present moderate or severe substance use disorder or alcohol use disorder, and past severe substance use disorder or alcohol use disorder, or psychotic disorder within the last 12 months
Where
- Tallahassee, Florida
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations