RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS (NCT05977439) | Clinical Trial Compass
RecruitingNot Applicable
RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS
United States120 participantsStarted 2024-02-01
Plain-language summary
In this research study, investigators examine how brain activity changes during tests of emotional processing, attention, and memory using multimodal neuroimaging methods including electroencephalography (EEG), functional magnetic resonance imaging (fMRI), and functional near-infrared spectroscopy (fNIRS). Transcranial magnetic stimulation (TMS) is used to probe and modulate brain networks related to cognitive flexibility and emotion regulation.
The study includes multiple related sub-studies involving healthy participants and participants with depression. Some study components focus on mechanistic modeling using non-therapeutic neurostimulation in healthy participants, while other components include interventional approaches such as individualized EEG-synchronized repetitive TMS (rTMS), cognitive tasks, and brief cognitive behavioral therapy (CBT) in participants with depression. Certain study components also evaluate CBT alone without TMS to assess behavioral intervention effects.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Study 1 (Healthy Participants)
Inclusion Criteria:
* Age 18-65 years
* Medically and psychiatrically healthy with no history of psychiatric or neurological disorders
* English-speaking
* Capacity to provide informed consent
* Willingness and ability to complete study procedures
* Negative pregnancy test for participants of childbearing potential
Exclusion Criteria:
* Any current or past psychiatric diagnosis
* Neurological disorders or history of central nervous system disease
* History of seizure or epilepsy or use of medications that lower seizure threshold
* Significant head injury or loss of consciousness
* Implanted metal or contraindications to MRI or TMS
* Substance use disorder (excluding nicotine or caffeine)
* Pregnancy or plans to become pregnant during study participation
* Inability to complete study procedures
Studies 2, 3, and 4 (Participants with Depression)
Inclusion Criteria:
* Age 18-65 years
* Current diagnosis of Major Depressive Disorder (MDD)
* Depression severity consistent with study criteria (e.g., HAM-D ≥ 17)
* No history of psychotic or bipolar disorders
* English-speaking
* Capacity to provide informed consent
* Willingness and ability to complete study procedures
* Negative pregnancy test for participants of childbearing potential
Exclusion Criteria:
* Neurological disorders or history of central nervous system disease
* History of seizure or epilepsy or use of medications that lower seizure threshold
* Significant head injury or loss of…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Hamilton Depression Rating Scale (HAM-D) Score
Timeframe: Baseline to Day 7
2
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Timeframe: Baseline to Day 7
3
Change in Suicidal Ideation Severity (Passive and Active Suicidal Ideation Scale [PASIS])