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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-24

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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The experiment comprises eight sessions total. People that request to be in the experiment will first complete demographic and self-report clinical assessments. People that meet our eligibility criteria will be invited to participate in the study. In the first session, clinical assessment are administered to determine eligibility for the full study. In the second session, participants complete a functional magnetic resonance imaging (MRI) session in which they complete three different reward-based decision-making tasks. After the MRI session, participants are randomized into one of three parallel arms to receive five consecutive days of cross-frequency transcranial alternating current stimulation (CF-tACS) in either delta-beta, control-frequency (theta-gamma), or placebo (sham) CF-tACS. In the third through seventh session, participants receive 40 minutes of CF-tACS while completing goal-setting and action planning worksheets. Before the first session of CF-tACS (the third session overall) and the last session of CF-tACS (the seventh session overall), participants complete brief self-report clinical assessments. On the third and seventh session (the first and fifth day of CF-tACS), the participant will complete the reward-based decision-making tasks prior to stimulation while EEG is recorded. In these two sessions, resting-state EEG is acquired before and after stimulation. The first and fifth session of tACS (third and seventh session overall) will take approximately three hours to complete. The second through fourth session of tACS (fourth through sixth session overall) will take approximately one hour to complete. In the follow-up session, visit 8, (approximately two weeks after the end of the five-days of stimulation), participants return for an in-person session that includes self-report clinical assessments and EEG during the reward-based decision-making tasks.

Conditions

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Major Depressive Disorder Anhedonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized into one of three arms of the study: delta-beta tACS, control tACS in theta-gamma, or active sham tACS.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

This study is designed to be double-blind. Participants and the researchers are unaware of each participant's assignment until the completion of all data collection. This is accomplished using randomization codes. Furthermore, this study utilizes an active sham stimulation. This means that the active sham condition includes some stimulation, mimicking the skin sensations associated with tACS. In a previously concluded trial, participants in the delta-beta tACS, theta-gamma tACS, and active sham groups responded similarly to the blinding questionnaire, indicating that the active sham stimulation successfully blinded the participants.

Study Groups

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Delta-beta tACS

The study is investigating the use of transcranial alternating current stimulation (tACS). The stimulation is delivered at 1 milliampere (mA) zero-to-peak amplitude at the target electrodes and 2 mA zero to-peak amplitude at the return electrode. For the experimental arm, the tACS will be delivered using the cross-frequency stimulation waveform delta-beta (3-20Hz).

Group Type EXPERIMENTAL

Delta-beta tACS via the Neurocare Direct Current Stimulator Multi-Channel 4

Intervention Type 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

This arm serves as an active control where tACS will be delivered using the cross-frequency stimulation waveform theta-gamma (5-50Hz).

Group Type ACTIVE_COMPARATOR

Theta-gamma tACS via the Neurocare Direct Current Stimulator Multi-Channel 4

Intervention Type 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.

Active-sham tACS

For active sham stimulation, either delta-beta or theta-gamma stimulation is delivered for 15 seconds only at the beginning and end of the stimulation period. This is intended to mimic the skin sensations (e.g., itching, burning, tingling) that are experienced at the onset and offest of stimulation, assisting with blinding the participant's assignment.

Group Type SHAM_COMPARATOR

Sham tACS via the Neurocare Direct Current Stimulator Multi-Channel 4

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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)

* 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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No