Causal Role of Delta-beta Coupling for Goal-directed Behavior in Anhedonic Depression

ConditionsMajor Depressive Disorder Anhedonia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorFlorida State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Delta-beta tACS via the Neurocare Direct Current Stimulator Multi-Channel 4
Device
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.
Theta-gamma tACS via the Neurocare Direct Current Stimulator Multi-Channel 4
Device
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.
Sham tACS via the Neurocare Direct Current Stimulator Multi-Channel 4
Device
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.

Treatment groups

72 Participants

are divided into 3 treatment groups

Group A: Delta-beta tACSExperimental treatment 1 intervention

Group B: Theta-gamma tACSActive comparator 1 intervention

Group C: Active-sham tACSSham comparator 1 intervention

Trial outcomes

Primary outcomes

Change in coupling strength between prefrontal and posterior cortex

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.

Time frame

1 week

Secondary outcomes

Change in Symptoms of anhedonia

Anhedonia is measured using the Snaith Hamilton Pleasure Rating Scale (SHAPS) which ranges from 14 to 56 where a larger value reflects greater symptoms of anhedonia.

Time frame

4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida State University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

Apply now