RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS

Healthy Clinical Trial

Official title:

RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS - Phase I Study: Multimodal Computational Modeling of Cognitive Flexibility and Emotion Regulation Networks

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977439
• Other study ID #: 00129566
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: October 1, 2028

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: Jacob McTeague, PhD
• Phone: 843-792-8274
• Email: MCTEAGUE[@]MUSC.EDU
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2028
• Est. primary completion date: October 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• fMRI-EEG-TMS
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.

Locations

Country	Name	City	State
United States	Medical Univeristy of South Carolina	Charleston	South Carolina

Sponsors (5)

Lead Sponsor	Collaborator
Medical University of South Carolina	Columbia University, Defense Advanced Research Projects Agency, University of Oklahoma, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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