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Behavioural Intervention

Brain Stimulation for Depression (DBA Trial)

N/A

Recruiting

Research Sponsored by Florida State University

Eligibility Criteria Checklist

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

Must have

Between the ages of 18 and 65

Have normal to corrected vision

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

DBA Trial Summary

This trial investigates if brain stimulation can reduce anhedonia, a symptom of depression which can lead to treatment-resistance. Five-day brain stimulation will be tested on participants with unipolar major depression and high anhedonia.

Who is the study for?

This trial is for adults aged 18-65 with major depressive disorder and anhedonia, who score high on specific depression scales. Participants must speak English, have good vision (with correction if needed), and be at low suicide risk. Exclusions include traumatic brain injury, certain medical conditions, metal implants or ferrous body materials, pregnancy, claustrophobia, prior brain surgery, current ADHD treatment or severe substance use disorders.Check my eligibility

What is being tested?

The study tests the effects of five consecutive days of transcranial alternating current stimulation (tACS) using a Neurocare stimulator to improve goal-directed behavior in people with anhedonic depression. It compares different tACS frequencies: Delta-beta coupling versus Theta-gamma coupling against a sham (fake) treatment.See study design

What are the potential side effects?

Potential side effects from tACS may include discomfort at the electrode sites on the scalp, headache during or after stimulation sessions, fatigue or difficulty concentrating post-treatment. These are generally mild and temporary.

DBA Trial Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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My vision is normal or corrected to normal.

DBA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in coupling strength between prefrontal and posterior cortex

Secondary outcome measures

Change in Symptoms of anhedonia

DBA Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Delta-beta tACSExperimental Treatment1 Intervention

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 II: Theta-gamma tACSActive Control1 Intervention

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

Group III: Active-sham tACSPlacebo Group1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,637 Total Patients Enrolled

17 Trials studying Anhedonia

1,804 Patients Enrolled for Anhedonia

Florida State UniversityLead Sponsor

200 Previous Clinical Trials

31,686 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants able to join this medical experiment at the present time?

"Contrary to what is posted on clinicaltrials.gov, this medical trial has concluded recruitment as of November 9th 2023. Despite the inactivity of this study, there are still a plethora of other research projects actively searching for participants."

Answered by AI

Does the research encompass participants of a younger age bracket?

"According to this trial's guidelines, only individuals aged 18-65 can participate. For those who are under 18 or over 65 there are 128 and 656 respective trials available for them."

Answered by AI

Does the enrollment period for this medical experiment remain open?

"This trial is seeking participants who suffer from anhedonia and meet the age criteria of 18 to 65. Currently, 72 candidates are needed for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Justin Riddle 2024. "Causal Role of Delta-beta Coupling for Goal-directed Behavior in Anhedonic Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06132581.