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Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation

NCT06940609 · University of New Mexico
In plain English

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Official title
Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation (MANIFEST)
About this study
Chronic neuropsychiatric symptoms of post-acute sequelae of COVID-19 (neuro-PASC) can lead to disability, loss of function, and reduced quality of life, but there are currently no validated effective treatments. We propose a randomized sham-controlled trial of "Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation (MANIFEST)." We will deliver active or sham accelerated iTBS (5x/day, 10 days, 25 blinded sessions followed by 25 open-label sessions) to each participant's brain target. We will assess neuro-PASC symptoms, mood, anxiety, cognition, and quality of life from baseline to end-of-treatment. We will correlate symptom improvement with clinical and imaging variables.
Eligibility criteria
Inclusion Criteria: 1. aged 18-80 2. a documented diagnosis of PASC with evidence of ongoing symptoms as demonstrated by score of 12 on the NIH RECOVER Symptom List 3. have "brain fog" or cognitive difficulties as one of the ongoing symptoms 4. are fluent in English 5. if taking psychotropic medications, have been on stable doses for the past month. Exclusion Criteria: 1. a prior history of other neurological disease, or any history of seizures, so as to reduce risk of exacerbation of epilepsy or other neurological symptoms; 2. history of a psychotic disorder, such as schizophrenia or bipolar disorder, so as to reduce risk of psychiatric decompensation 3. history of ongoing substance/alcohol dependence, to reduce confounding effects on diagnosis and brain imaging 4. presence of any implanted electrical device (e.g., pacemaker), to reduce risk of device malfunction from rTMS 5. recent medical hospitalization (within four weeks), to reduce risk of medical decompensation during the study 6. any condition that would prevent the subject from completing the protocol 7. appointment of a legal representative, to avoid coercion of a vulnerable population 8. any ongoing litigation related to medical diagnosis, or disability, to prevent interference with legal proceedings 9. any contraindication to MRI 10. membership in an identified vulnerable population, including minors, pregnant women, and prisoners, so as to prevent coercion.
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-07-07
Estimated completion: 2029-06-30
Last updated: 2025-07-15
Interventions
Device: accelerated intermittent theta burst stimulation
Primary outcomes
  • Aim 1 (From baseline to end of treatment at 2 weeks)
  • Aim 2 (From baseline to end of treatment at 2 weeks)
Sponsor
University of New Mexico · other
With: The Mind Research Network, United States Department of Defense
Contacts & investigators
ContactCrystal Garcia · contact · crabaca@salud.unm.edu · 505-272-9552
InvestigatorDavin Quinn, MD · principal_investigator, University of New Mexico
All locations (1)
University of New Mexico Health Science CenterRecruiting
Albuquerque, New Mexico, United States
Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation · TrialPath