RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS

NCT05977439 | Recruiting FDA Device

• 1 other identifier: 00129566
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy; Depression - Major Depressive Disorder

Keywords

healthy volunteer; transcranial magnetic stimulation (TMS); electroencephalography (EEG); magnetic resonance imaging (MRI); functional near-infrared spectroscopy (fNIRS); cognitive behavioral therapy (CBT)

Outcome Measures

Primary Outcomes (8)

• Change in reaction time (RT) tasks - Incongruent Stimuli

  Tasks will be used to see differences between incongruent emotional stimuli.

  Day 1, Day 2, Day 3

• Change in reaction time (RT) tasks - Congruent Stimuli

  Tasks will be used to see differences between congruent emotional stimuli.

  Day 1, Day 2, Day 3

• Change in reaction time (RT) tasks and accuracy - Incongruent Stimuli

  Tasks will be used to see differences between incongruent emotional stimuli.

  Day 1, Day 2, Day 3

• Change in reaction time (RT) tasks and accuracy - Congruent Stimuli

  Tasks will be used to see differences between congruent emotional stimuli.

  Day 1, Day 2, Day 3

• Clinical Improvement

  25% reduction in Hamilton Score (HAMD) as a meaningful treatment response.

  Day 13, Day 18

• Clinical Improvement

  25% reduction in Passive and Active Suicidal Ideation Scale (PASIS) as a meaningful treatment response.

  Day 13, Day 18

• Clinical Improvement

  25% reduction in Patient Health Questionnaire (PHQ-9) as a meaningful treatment response.

  Day 13, Day 18

• Clinical Improvement

  25% reduction in Generalized Anxiety Disorder -7 Questionnaire (GAD7) as a meaningful treatment response.

  Day 13, Day 18

Study Arms (2)

Healthy Participants

Endorse good health with no history of mental or physical illness or implanted metal

Device: fMRI-EEG-TMS; Device: fNIRS-EEG-TMS

Depressed Participants

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).

Device: fMRI-EEG-TMS; Device: fNIRS-EEG-TMS; Device: fNIRS-EEG-rTMS Interleaved with CBT

Interventions

fMRI-EEG-TMS DEVICE

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.

Depressed Participants; Healthy Participants

fNIRS-EEG-TMS DEVICE

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.

Depressed Participants; Healthy Participants

fNIRS-EEG-rTMS Interleaved with CBT DEVICE

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.

Depressed Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are healthy and depressed volunteers from the community.

You may qualify if:

• 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

You may not qualify if:

• 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
• Male or female

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Columbia University: collaborator
• University of Oklahoma: collaborator
• Defense Advanced Research Projects Agency: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Medical Univeristy of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Study Officials

• Lisa McTeague, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa McTeague, PhD

CONTACT

843-792-8274; MCTEAGUE@MUSC.EDU

Jacob Eade, MS

CONTACT

recovers@musc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: August 4, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)