Status:
RECRUITING
RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Columbia University
University of Oklahoma
Conditions:
Healthy
Depression - Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Brief 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 imag...
Detailed Description
Investigators hypothesize that targeted neuroplastic changes induced by individually-tailored rTMS will substantially reduce clinical symptoms underlying depression, anxiety and suicidality, and in ge...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05977439
Start Date
February 1 2024
End Date
October 1 2028
Last Update
September 2 2025
Active Locations (1)
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1
Medical Univeristy of South Carolina
Charleston, South Carolina, United States, 29425