Last reviewed · How we verify

NCT05693922: ABBA

Augmenting Single-session Behavioral Activation (BA) With Delta-beta Transcranial Alternating Current Stimulation (tACS) for the Treatment of Depression

Completed NA Results posted Last updated 20 May 2025
What this trial tests

NA trial testing Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC in Major Depressive Disorder in 30 participants. Completed in 22 May 2024.

Timeline
9 February 2023
Primary endpoint
22 May 2024
22 May 2024

Quick facts

Lead sponsorUniversity of North Carolina, Chapel Hill
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment30
Start date9 February 2023
Primary completion22 May 2024
Estimated completion22 May 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of North Carolina, Chapel Hill

Who can join

18 and older, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinician-rated Depressive Symptoms Primary · Baseline, 2 weeks post treatment

Treatment response will be reported for clinician-rated depression symptom scores using the Hamilton Depression Rating Scale (HDRS). Items are scaled either from 0-2 to 0-4, and each item is summed for a total score ranging from 0 to 53 with higher scores indicating greater depression symptoms. Benchmarks suggested at: 0-7 normal; 8-13 mild depression; 14-18 moderate depression; 19-22 severe depression; \>=23 very severe depression.

Baseline
GroupValue95% CI
Delta-beta tACS19.33± 4.59
Active-sham tACS19.93± 4.71
2 weeks post treatment
GroupValue95% CI
Delta-beta tACS11.33± 5.15
Active-sham tACS13.93± 6.23
Phase-amplitude Coupling (PAC) Between Delta-beta Oscillations During Task Performance of the Streamlined Expenditure of Effort for Reward Task (S-EEfRT) Secondary · Baseline, 2 weeks post treatment

Participants choose to complete a "hard" task or "easy" task. Coupling during the hard/easy decision is calculated between delta oscillations phase (2-3Hz) in prefrontal electrodes (FCz and surrounding electrodes) and the beta oscillations amplitude (15-25Hz) in left motor electrodes (C3 and surrounding electrodes). Instantaneous phase \& amplitude of oscillations is calculated by averaging the signal in the two regions, band-filtering the signal to the specified range, and performing the Hilbert transform. PAC is normalized by creating a null distribution randomly shifting the beta time serie

Baseline
GroupValue95% CI
Delta-beta tACS0.286± 0.606
Active-sham tACS0.290± 0.516
2 weeks post treatment
GroupValue95% CI
Delta-beta tACS0.286± 0.786
Active-sham tACS0.044± 0.655
Proportion of Hard Trials Chosen During the S-EEfRT Secondary · Baseline, 2 weeks post treatment

In the Streamlined Expenditure of Effort for Reward Task (S-EEfRT), participants choose to complete a "hard" task requiring many button presses or an "easy" task with fewer button presses for variable monetary incentives. Number of button presses is individualized for each participant. Goal-directed behavior will be calculated as the proportion of "hard" tasks chosen across trials.

Baseline
GroupValue95% CI
Delta-beta tACS0.562± 0.158
Active-sham tACS0.521± 0.205
2 weeks post treatment
GroupValue95% CI
Delta-beta tACS0.504± 0.188
Active-sham tACS0.454± 0.103

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time of signing informed consent through intervention visit (1 week later) and study follow-up visit (2 weeks after intervention), approximately 3 weeks total.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Delta-beta tACS
Serious: 0/15 (0%)
Deaths: 0/15
Active-sham tACS
Serious: 0/15 (0%)
Deaths: 0/15
Other adverse events (4 terms — click to expand)

ReactionSystemDelta-beta tACSActive-sham tACS
Warm Skin SensationSkin and subcutaneous tissue disorders
Flickering LightsEye disorders
TinglingSkin and subcutaneous tissue disorders
Suicidal IdeationPsychiatric disorders

Data from ClinicalTrials.gov NCT05693922 adverse events section.

Sponsor's own description

Investigating whether delta-beta cross-frequency transcranial alternating current stimulation can augment the effects of a single session of behavioral activation in participants with major depressive disorder.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Transcranial alternating current stimulation for neuropsychiatric disorders: a systematic review of treatment parameters and outcomes.
    Gholamali Nezhad F, Martin J, Tassone VK, Swiderski A, et al · · 2024 · cited 7× · PMID 39211537 · DOI 10.3389/fpsyt.2024.1419243
  2. ACNP 63rd Annual Meeting: Poster Abstracts P1-P304
    · 2024
  3. Augmenting single-session behavioral activation for depression with delta-beta tACS: Preliminary investigation of a double-blind placebo-controlled randomized pilot clinical trial.
    Carlton CN, Bondy E, Riddle J, Mahan D, et al · · 2025 · PMID 40657349 · DOI 10.1016/j.xjmad.2025.100127

Verify or expand the search:

Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

Other University of North Carolina, Chapel Hill trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05693922.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing