RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS
Study Details
Study Description
Brief Summary
In this research study, the investigators are using examining how brain activity (electrical and blood flow) changes during tests of emotional processing and attention and memory in the magnetic resonance imaging (MRI) scanner. Investigators are also using non-invasive brain stimulation to probe different parts of the brain and measuring brain activity (electrical and blood flow). This study includes healthy participants and researchers hope this will help us develop improved brain-based treatments for emotional difficulties like depression.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 general, revolutionize non-invasive treatments of mental health disorders. Investigators hypothesize that functional coupling in cognitive flexibility (CF) and emotion regulation (ER) networks is indexed by the phase of the brain's alpha oscillations. Using a novel integrated instrument that enables simultaneous functional magnetic resonance imaging (fMRI), electroencephalography (EEG) and transcranial magnetic stimulation (TMS), investigators propose to identify individualized stimulation parameters that reflect the strongest coupling of the CF/ER networks. The neuromechanistic model further posits that by applying repetitive TMS (rTMS) with these individualized parameters, one can induce entrainment in brain networks that drive neuroplastic changes in CF and ER. This initial Phase I Task 3 sub-study is a proof-of-principle study in healthy control participants.
Study Design
Outcome Measures
Primary Outcome Measures
- Change in reaction time (RT) tasks - Incongruent Stimuli [Day 1, Day 2, Day 3]
Tasks will be used to see differences between incongruent emotional stimuli.
- Change in reaction time (RT) tasks - Congruent Stimuli [Day 1, Day 2, Day 3]
Tasks will be used to see differences between congruent emotional stimuli.
- Change in reaction time (RT) tasks and accuracy - Incongruent Stimuli [Day 1, Day 2, Day 3]
Tasks will be used to see differences between incongruent emotional stimuli.
- Change in reaction time (RT) tasks and accuracy - Congruent Stimuli [Day 1, Day 2, Day 3]
Tasks will be used to see differences between congruent emotional stimuli.
Eligibility Criteria
Criteria
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 psychotropic medication is taken within 5 half-lives of procedure time
-
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).
-
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medical University of South Carolina
- Columbia University
- University of Wisconsin, Madison
- University of Oklahoma
- Defense Advanced Research Projects Agency
Investigators
- Principal Investigator: Lisa McTeague, PhD, Medical University of South Carolina
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00129566