Exploring brain activity and emotional processing in healthy individuals and those with depression
RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS - Phase I Study: Multimodal Computational Modeling of Cognitive Flexibility and Emotion Regulation Networks
This study is trying to see how brain activity related to emotions works differently in healthy people and those with depression, to help find better treatments for emotional challenges.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05977439 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how brain activity related to emotional processing, attention, and memory changes in healthy participants and those with major depressive disorder. Using advanced imaging techniques like MRI and fNIRS, along with non-invasive brain stimulation methods such as TMS, researchers aim to understand the brain's neuroplasticity and its implications for treating emotional difficulties. The study seeks to identify individualized stimulation parameters that enhance cognitive flexibility and emotion regulation, potentially leading to improved treatments for depression and related conditions.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18-65 with no history of mental or physical illness.
Not a fit: Patients with current psychiatric diagnoses or significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to more effective brain-based treatments for depression and emotional disorders.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using neurostimulation and imaging techniques to understand and treat mental health disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Study 1 Inclusion Criteria * 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 Exclusion Criteria * 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 Inclusion Criteria * 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 Criteria * 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
Where this trial is running
Charleston, South Carolina
- Medical Univeristy of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Lisa McTeague, PhD — Medical University of South Carolina
- Study coordinator: Lisa McTeague, PhD
- Email: MCTEAGUE@MUSC.EDU
- Phone: 843-792-8274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.