RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS
RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS - Phase I Study: Multimodal Computational Modeling of Cognitive Flexibility and Emotion Regulation Networks
Medical University of South Carolina
30 participants
Feb 1, 2024
OBSERVATIONAL
Conditions
Summary
In this research study, the investigators are examining how brain activity (electrical and blood flow) changes during tests of emotional processing, attention and memory in the magnetic resonance imaging (MRI) scanner and outside the MRI using functional near-infrared spectroscopy (fNIRS). Investigators are also using non-invasive brain stimulation to probe different parts of the brain and measuring brain activity (electrical and blood flow). Study 1 This study includes healthy participants and researchers hope this will help us develop improved brain-based treatments for emotional difficulties like depression. Study 2 This study includes participants with depression and researchers hope this will help us develop improved brain-based treatments for emotional difficulties like depression.
Eligibility
Inclusion Criteria15
- Study 1
- Male or female
- Age 18-65
- Endorse good health with no history of mental or physical illness or implanted metal
- English as a primary language
- Capacity to consent
- Negative urine pregnancy test if female of childbearing potential
- Willingness to adhere to the study schedule and assessments
- Male or female
- Age 18-65
- Endorse current depression, identified via the Hamilton Depression Rating Scale (HAM-D scores ≥ 17), but no history of psychosis or mania, determined via the Quick Structured Clinical Interview for DSM-5 Disorders (SCID).
- English as a primary language
- Capacity to consent
- Negative urine pregnancy test if female of childbearing potential
- Willingness to adhere to the study schedule and assessments
Exclusion Criteria22
- Any current psychiatric diagnosis or current Clinical Global Impression ratings of psychiatric illness \> 1
- Neurodevelopmental disorders, history of CNS disease, concussion, overnight hospitalization, or other neurologic sequela, tumors, seizures, meningitis, encephalitis, or abnormal CT or MRI of the brain
- Any head trauma resulting in loss of consciousness
- Visual impairment (except the use of glasses)
- Inability to complete cognitive testing
- Active participation or plan for enrollment in clinical trial affecting the psychosocial function
- Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) or taking medications including stimulants, modafinil, thyroid medication, or steroids
- Implanted devices/ferrous metal of any kind
- History of seizure or epilepsy, currently taking medications that lower seizure thresholds
- Claustrophobia or other conditions that would prevent the MRI assessment.
- Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term).
- o Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precautions should be taken. Examples of acceptable methods of birth control for participants involved in the study include birth control pills, patches, IUDs, condoms, sponges, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant.
- Inability to adhere to the treatment schedule
- Study 2
- Neurodevelopmental disorders, history of CNS disease, concussion, overnight hospitalization, or other neurologic sequela, tumors, seizures, meningitis, encephalitis, or abnormal CT or MRI of the brain
- Any head trauma resulting in loss of consciousness
- Visual impairment (except the use of glasses)
- Inability to complete cognitive testing
- Active participation or plan for enrollment in clinical trial affecting the psychosocial function
- Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) or taking medications including stimulants, modafinil, thyroid medication, or steroids
- Implanted devices/ferrous metal of any kind
- History of seizure or epilepsy, currently taking medications that lower seizure thresholds
Interventions
Participants will undergo a magnetic resonance imaging (MRI) scan with combined electroencephalography (EEG), and single-pulse transcranial magnetic stimulation (TMS) while completing cognitive flexibility (CF) and emotion recognition (CR) tasks.
Participants brain activity will be measured using functional near-infrared spectroscopy (fNIRS) with combined electroencephalography (EEG), and single-pulse transcranial magnetic stimulation (TMS) while completing cognitive flexibility (CF) and emotion recognition (CR) tasks.
Participants brain activity will be measured using functional near-infrared spectroscopy (fNIRS) with combined electroencephalography (EEG), and repetitive transcranial magnetic stimulation (rTMS). rTMS will be delivered via a MagVenture MagPro100 and Cool-B65 coil. The investigators will use a standard resting motor threshold (rMT) determination to determine the TMS dose. Treatment will be delivered at 120% of the motor threshold. The accelerated paradigm will consist 6 session a day for 5-6 days. Each rTMS session will be separated by 30 minutes of Cognitive Behavioral Therapy (CBT). rTMS treatment will be delivered at an individualized left DLPFC target based on each participant's individualized scans from prior neuroimaging sessions.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05977439