Decoding Emotional Dynamics in Bipolar Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLaureate Institute for Brain Research, Inc.
About this trial
The goal of this neuroimaging study is to investigate how emotional states fluctuate in people with bipolar disorder (BD) compared to healthy controls, and to understand the neural mechanisms driving mood instability. The main questions it aims to answer are:
* Can emotional states be decoded from fMRI brain activity using machine learning? * Do individuals with BD show more unstable emotional state trajectories (e.g., high metastability, low fractal scaling) than healthy controls? * Does amplifying positive emotions stabilize brain and emotional dynamics in BD?
Researchers will compare individuals with bipolar disorder (BD-I or BD-II, currently depressed or mixed state) to healthy controls without psychiatric history to see whether the BD group shows greater fluctuations in emotional brain activity and whether positive emotion regulation strategies normalize this instability.
Participants will:
* Complete self-report questionnaires on mood, emotion regulation, anxiety, and daily functioning. * Recall and provide short descriptions of personal positive and negative memories to be used in the MRI task. * Undergo fMRI scanning, including: * Resting-state scans * A Think and Regulate Affective States Task (TReAT) where they recall autobiographical memories, rate emotions, and practice amplifying positive mood. * Structural and diffusion MRI for brain mapping. * Receive physiological monitoring (heart rate, respiration) during scanning. * Complete post-scan surveys on emotional state and task experience.
This research will help clarify how the brain supports or disrupts emotional regulation in bipolar disorder and may inform the development of personalized, neurobiologically informed treatments for mood instability.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 to 65 years
Male or female
BMI between 18.5 and 38.0 kg/m2 at Screening
Capable of understanding and complying with study requirements
Disqualifiers
No telephone or easy access to a telephone
Significant medical problems as identified by the medical screening questionnaire: e.g. a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
A positive test for drugs of abuse, including alcohol (breath test), cocaine, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone
Drug or alcohol intoxication (based on positive UTOX or breathalyzer test at screening or study session) or reported alcohol/drug withdrawal, last cannabis use must be >48 hours prior to study session.
Trial design
Design model
Single group
Treatments tested in this trial
Think and Regulate Affective State Task
BehavioralParticipants complete the Think and Regulate Affective States Task (TReAT) during fMRI scanning. This task presents brief cues of participants' own autobiographical memories, four positive and four negative, to evoke corresponding emotional states. While viewing these cues, participants alternate between thinking about the memory, rating emotional valence and arousal, and practicing positive emotion amplification strategies. Each session includes multiple blocks of "Think," "Rate," "Regulate," "Attention," and "Rest" periods. Physiological measures (heart rate and respiration) are recorded concurrently. The task is designed to decode emotional states from fMRI data and evaluate the neural impact of positive emotion regulation in bipolar disorder compared to healthy controls.
Treatment groups
72 Participants
are divided into 1 treatment groupGroup A: Decoding Emotional DynamicsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Decoded Emotional State Trajectory
The decoded emotional state time course derived from fMRI during the Think and Regulate Affective States Task (TReAT). Temporal irregularity will be quantified using permutation entropy to assess emotional state instability in individuals with bipolar disorder compared to healthy controls.
Time frame
Day 22
Metastability of brain network states
Metastability of brain network states will be calculated from whole-brain fMRI data to characterize variability in emotional states.
Time frame
Day 2Secondary outcomes
1
Brain regional contributions to the transition energy of emotional brain state changes
Brain regional contributions to the transition energy of emotional brain state changes, derived from network control theory, will be calculated to identify regions that drive transitions between emotional states.
Time frame
Day 22
Fractal scaling of brain state changes
Fractal scaling of brain state changes will be calculated from whole-brain fMRI data to characterize the regularity of emotional brain states.
Time frame
Day 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Laureate Institute for Brain Research, Inc.
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov