What side effects are associated with this type of intervention?

Common treatments for depression, such as tACS, TMS, and ECT, have varying side effects. tACS and TMS are generally well-tolerated, with mild side effects including headaches, scalp discomfort, and tingling sensations. ECT, while effective, can cause more significant side effects such as short-term memory loss, confusion, and physical side effects like muscle aches. Pharmacotherapy, including antidepressants, can lead to side effects such as nausea, weight gain, sexual dysfunction, and insomnia. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several neuromodulation techniques for the treatment of depression. Electroconvulsive therapy (ECT) is a well-established treatment for major depressive disorder, particularly in treatment-resistant cases. Repetitive transcranial magnetic stimulation (rTMS) is another FDA-approved method that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression. Both treatments aim to modulate brain activity to enhance mood and cognitive function, similar to the investigational delta-beta cross-frequency transcranial alternating current stimulation (tACS).

What other types of research exist?

Promising, novel alternatives to Delta-beta cross-frequency tACS for depression patients in 2024 include: 1) Electroconvulsive Therapy (ECT), which has robust evidence supporting its efficacy in treatment-resistant depression. 2) Transcranial Direct Current Stimulation (tDCS), which has shown potential in improving mood and cognitive function. 3) Repetitive Transcranial Magnetic Stimulation (rTMS), which is non-invasive and has been effective in many patients. 4) Deep Brain Stimulation (DBS), which is more invasive but can be highly effective for severe cases.

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Behavioral Intervention

tACS + Behavioral Activation for Depression (ABBA Trial)

N/A

Waitlist Available

Led By Flavio Frohlich, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years old or order

Be older than 18 years old

Must not have

(for female participants) Participants must not be pregnant or breastfeeding.

Participants may not have a history of brain injury requiring current treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to follow-up 2 weeks post treatment

Summary

This trial is testing if a type of brain stimulation combined with a therapy session can help people with depression feel better. The brain stimulation uses small electrical currents to improve brain function, while the therapy encourages positive activities.

Who is the study for?

This trial is for English-speaking adults with major depressive disorder, as confirmed by the MINI. They must understand and consent to study procedures and be available throughout the study. Exclusions include recent brain injury or surgery, severe substance use disorders, active psychosis, ongoing psychotherapy or brain stimulation treatments within the last month, unstable psychotropic medication use, pregnancy/breastfeeding, and certain medical/neurological conditions.

What is being tested?

The trial tests if delta-beta transcranial alternating current stimulation (tACS) can boost a single session of behavioral activation therapy for depression. Participants will receive either real tACS or a sham (inactive) version alongside their therapy session to compare effects.

What are the potential side effects?

Potential side effects from tACS may include mild discomfort at the electrode sites on the scalp during stimulation, headache after treatment sessions, fatigue or dizziness. However, these are typically temporary and resolve shortly after each session.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant or breastfeeding.

Select...

I do not need treatment for a past brain injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to follow-up 2 weeks post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to follow-up 2 weeks post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to follow-up 2 weeks post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in clinician-rated depressive symptoms

Secondary study objectives

Change in percentage of hard trials chosen during the S-EEfRT

Change in phase-amplitude coupling between delta-beta oscillations during task performance of the Streamlined Expenditure of Effort for Reward Task (S-EEfRT)

Other study objectives

Change in clinician-rated anhedonia symptoms using SHAPS-C

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Delta-beta tACSExperimental Treatment2 Interventions

Participants will receive a single session intervention of behavioral activation (BA) psychotherapy. Stimulation will be delivered via the NeuroConn DC-STIMULATOR MC at 1 milliampere (mA) zero-to-peak amplitude at the target electrodes and 2 mA zero to-peak amplitude at the return electrode. The tACS will be delivered using the cross-frequency stimulation waveform delta-beta (3-20Hz).

Group II: Active-sham tACSPlacebo Group2 Interventions

Participants will receive a single session intervention of behavioral activation (BA) psychotherapy. The active sham condition includes brief stimulation, mimicking the skin sensations associated with tACS, assisting with blinding the participant's assignment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC

2023

N/A

~30

Single-session behavioral activation

2023

N/A

~30

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression work by modulating brain activity and neurotransmitter levels to improve mood and cognitive function. Antidepressants adjust levels of serotonin, norepinephrine, and dopamine. Non-pharmacological treatments like electroconvulsive therapy (ECT) and brain stimulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) aim to alter brain activity and connectivity. Specifically, Delta-beta transcranial alternating current stimulation (tACS) modulates brain oscillations to enhance mood and cognitive function. Understanding these mechanisms helps tailor treatments to individual needs, improving the likelihood of achieving remission.