Laboratory for Brain-Machine Interfaces and Neuromodulation, Pontificia Universidad Católica de Chile
Santiago, RM, 8320000, Chile
NCT Number: NCT07815457
This completed feasibility study examined whether right-handed women aged 18-35 years with mild-to-moderate depressive symptoms could use real-time electroencephalography (EEG) neurofeedback based on a subject-independent classifier to regulate brain activity toward a classifier-defined reference pattern. Participants were randomly assigned to receive either classifier-contingent visual feedback with performance-contingent monetary rewards or noncontingent sham visual feedback with yoked monetary rewards. All participants completed five training sessions over approximately 3 weeks. The primary purpose was to determine whether overall classifier accuracy during training exceeded the theoretical 50% chance level. Changes in clinician-rated and self-reported depressive symptoms, associations between classifier performance and symptom change, EEG spatial patterns, and procedural tolerability were exploratory.
Looking for future studies?
Notify Me18 year–35 year
Female
Interventional
Not applicable
Santiago, RM, 8320000, Chile
The subject-independent classifier had been developed from EEG recordings obtained from an independent reference sample of healthy right-handed women during positive autobiographical memory recall and motor imagery. It used a Filter Bank Common Spatial Pattern feature-extraction pipeline and a linear support vector machine to classify the two mental states from 28 EEG channels.
After eligibility and baseline assessments, participants were randomly assigned in a 1:1 ratio to an experimental or control arm using a sequence generated before the intervention. Participants and the clinical psychologists administering the Hamilton Depression Rating Scale were masked to allocation. The experimental arm was implemented before the control arm because the control rewards were yoked to a reward sequence generated in the experimental arm; this operational sequence did not determine assignment.
Each participant completed five EEG neurofeedback sessions on separate days over approximately 3 weeks. Each session contained four 300-second runs. In each run, participants completed positive autobiographical memory recall and motor imagery blocks while viewing a thermometer-like display. In the experimental arm, the display was updated approximately once per second according to the classifier output and monetary rewards depended on run-level classifier accuracy. In the control arm, display movements were random and independent of EEG activity, and rewards were yoked to the run-by-run reward sequence of the experimental participant with the highest total reward.
This record was created retrospectively after study completion. The protocol information reflects the completed study procedures and the outcome hierarchy reported in the final manuscript; exploratory analyses have not been promoted to primary outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Five sessions were delivered on separate days over approximately 3 weeks. Each session comprised four 300-second runs separated by 1-3-minute rest intervals. Each run contained four 20-second positive autobiographical memory recall blocks and four 20-second motor imagery blocks. A pretrained Filter Bank Common Spatial Pattern-linear support vector machine classifier processed 28 EEG channels in real time. The visual thermometer rose or fell by one level according to whether each classifier output matched the instructed mental state. At the end of each run, participants viewed classifier accuracy and received a prespecified performance-contingent monetary reward.
Participants received the same five-session schedule, task structure, visual display, and scripted instructions as the experimental arm. Each thermometer update was a randomly determined one-level increase or decrease and was independent of EEG activity. Rewards followed the run-by-run sequence obtained by the experimental-arm participant with the highest total reward and were not contingent on the control participant's classifier performance.
Time frame: Across five training sessions over approximately 3 weeks
Classifier accuracy was the percentage of classifier outputs during regulation blocks that matched the instructed mental state. Each run contained 160 classifier outputs during regulation periods. Run-level accuracy was averaged across four runs to obtain a session-level value, and session-level accuracy was averaged across five sessions for each participant. Overall accuracy was compared with the theoretical 50% chance level within each arm and between arms.
Time frame: Each of five training sessions over approximately 3 weeks
For each participant, the percentage of classifier outputs matching the instructed mental state was averaged across four runs separately for Sessions 1, 2, 3, 4, and 5. Session-specific accuracy was compared with the theoretical 50% chance level within each arm.
Time frame: Early training: Sessions 1-2; late training: Sessions 4-5, over approximately 3 weeks
Early-training accuracy was the mean of Sessions 1 and 2. Late-training accuracy was the mean of Sessions 4 and 5. Each phase was compared with the theoretical 50% chance level, early-to-late change was assessed within each arm, and phase-specific values were compared between arms.
Time frame: Baseline at 1-2 days before Session 1 to 1-2 days after Session 5; and baseline to 10-14 days after Session 5
The Hamilton Depression Rating Scale was administered by trained clinical psychologists masked to allocation. Lower scores indicate fewer clinician-rated depressive symptoms. Change was calculated as baseline score minus the later score; positive values indicate symptom improvement. Analyses used available paired observations without imputation.
Time frame: Baseline at 1-2 days before Session 1 to 1-2 days after Session 5; and baseline to 10-14 days after Session 5
The Beck Depression Inventory-II is a self-reported measure of depressive symptom severity. Lower scores indicate fewer symptoms. Change was calculated as baseline score minus the later score; positive values indicate symptom improvement. Analyses used available paired observations without imputation.
Time frame: Classifier performance: across five training sessions over approximately 3 weeks; HDRS assessments: baseline (1-2 days before Session 1), immediate post-training (1-2 days after Session 5), and follow-up (10-14 days after Session 5).
Correlations were calculated separately by arm between classifier performance and clinician-rated depressive symptom change measured with the Hamilton Depression Rating Scale (HDRS). Classifier accuracy was defined as the percentage of classifier outputs during regulation blocks that matched the instructed mental state. Overall, session-specific, early- and late-training accuracy were expressed as percentages; changes in accuracy were expressed as percentage points; and the accuracy slope across Sessions 1-5 was expressed as percentage points per session. HDRS change was expressed in scale points and calculated as CE0-CE1, CE0-CE2, and CE1-CE2; positive values indicate symptom reduction. Pearson's r was used when both variables met normality assumptions; otherwise, Spearman's rho was used. Correlation coefficients are unitless and range from -1 to +1.
Time frame: Classifier performance: across five training sessions over approximately 3 weeks; BDI-II assessments: baseline (1-2 days before Session 1), immediate post-training (1-2 days after Session 5), and follow-up (10-14 days after Session 5).
Correlations were calculated separately by arm between classifier performance and self-reported depressive symptom change measured with the Beck Depression Inventory-II (BDI-II). Classifier accuracy was defined as the percentage of classifier outputs during regulation blocks that matched the instructed mental state. Overall, session-specific, early- and late-training accuracy were expressed as percentages; changes in accuracy were expressed as percentage points; and the accuracy slope across Sessions 1-5 was expressed as percentage points per session. BDI-II change was expressed in scale points and calculated as CE0-CE1, CE0-CE2, and CE1-CE2; positive values indicate symptom reduction. Pearson's r was used when both variables met normality assumptions; otherwise, Spearman's rho was used. Correlation coefficients are unitless and range from -1 to +1.
Time frame: Training Sessions 1 and 5 over approximately 3 weeks
The common spatial pattern filter matrix was inverted to derive spatial patterns for the 28 EEG channels. Participant-level patterns were normalized by Euclidean norm and averaged separately by arm, mental task, and session. The maps were descriptive; no inferential comparisons were planned.
Time frame: Throughout five training sessions and through final follow-up, approximately 5 weeks
Participants were repeatedly asked about perceived stress and comfort during the protocol. Intervention-related discomfort and adverse events were summarized by arm. This was a procedural tolerability assessment rather than a formally adjudicated adverse-event endpoint.
Looking for future studies?
Notify MePontificia Universidad Catolica de Chile
Other
A Randomized, Double-blind Feasibility Study of a Subject-independent Classifier-based EEG Neurofeedback in Women With Depressive Symptoms
Acronym: SIC-EEG-NF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07638553
Alcohol Use Disorder, Alcohol-Related Disorders
Bayonne, France
View Trial DetailsNCT07531082
Depressive Sympotoms
View Trial Details