Clinical trial NCT05084924: Investigating the Causal Role of Prefrontal Control in Decision-making in Patients With Anhedonia
Official title: Causal Role of Delta-beta Coupling for Goal-directed Behavior in Anhedonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Anhedonia
Keywords: transcranial Alternating Current Stimulation
Goal-directed behavior
Cross-frequency coupling
Reward-based decision-making
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-10-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized into one of three arms of the study: delta-beta tACS, control tACS in theta-gamma, or active sham. Randomization is stratified by SHAPS level such that there are an equal number of participants that are high anhedonia (SHAPS \> 33) and low anhedonia (SHAPS \<=33).
Primary purpose: BASIC_SCIENCE

Brief summary: Investigating whether delta-beta cross-frequency transcranial alternating current stimulation can increase goal-directed behavior in participants with major depressive disorder and elevated symptoms of anhedonia.

Detailed description: The purpose of this clinical trial is to investigate the causal role that delta-beta coupling plays in goal-directed behavior in participants with major depressive disorder (MDD) and symptoms of anhedonia. The participants will perform a reward-based decision-making task. During the task, cross-frequency transcranial alternating current stimulation (tACS) will be delivered at delta-beta frequency, a control-frequency, or an active sham. Electroencephalography will be collected in intermittent resting-state periods. Structural and functional magnetic resonance imaging (MRI) will be collected during the resting-state and during performance of the task.

Eligibility criteria: Inclusion Criteria:

* 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
* Low suicide risk as determined by the Columbia Suicide Severity Rating Scale (C-SSRS), and by the Hamilton Depression Rating Scale (HAM-D; less than 3 for the suicidality item).
* Negative pregnancy test for female participants
* Patient Health Questionnaire (PHQ) with 9 items greater than or equal to 10 and a diagnosis of major depressive disorder on the Mini International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

* Attention deficit (hyperactivity) disorder (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 (e.g., unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment)
* Prior brain surgery
* Any brain devices/implants, including cochlear implants and aneurysm clips
* History of current traumatic brain injury
* (For females) Pregnant or breast feeding
* 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
* Diagnostic and Statistical Manual of Mental Disorders version 5 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
* Not taking medications for attention deficit (hyperactivity) disorder or benzodiazepines as these medications often produce specific EEG activity that may disrupt our interpretation of the findings
* If major depressive disorder is experienced in episode, the participant must currently be within a depressive episode.
* Contraindications for magnetic resonance imaging (MRI): ferrous metal inside the body, jewelry must be removable, pacemaker or cochlear implant.

Primary outcomes:
measure: Change in the Percentage of Trials That the Participant Chooses to Perform the Hard Task
timeFrame: Baseline (Hour 1), Stimulation (Hours 2 through 3)
Secondary outcomes:
measure: Change in Coupling Strength Between Low-frequency Prefrontal Signals and High-frequency Posterior Signals
timeFrame: Baseline (Hour 1), Stimulation (Hours 2 through 3)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Flavio Frohlich
role: PRINCIPAL_INVESTIGATOR
References: