Magnetic resonance and rapid brain stimulation for Long COVID cognitive and mood symptoms
Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation (MANIFEST)
This trial will test whether an accelerated outpatient magnetic brain stimulation (iTBS) can help reduce brain fog, depression, and anxiety in adults with Long COVID.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of New Mexico Academic / other |
| Locations | 1 site (Albuquerque, New Mexico) |
| Trial ID | NCT06940609 on ClinicalTrials.gov |
What this trial studies
This is a randomized, sham-controlled Phase 2 trial delivering accelerated intermittent theta burst stimulation (iTBS) to individualized brain targets in people with neuro-PASC. Participants receive multiple daily outpatient iTBS sessions over a course of treatment with a blinded phase followed by open-label sessions. Symptom surveys, cognitive tests, and MRI scans (including measures of brain choline as a marker of inflammation) are collected at baseline, mid-treatment, and end-of-treatment. Investigators will compare symptom change between active and sham groups and correlate clinical improvements with imaging measures.
Who should consider this trial
Good fit: Adults aged 18–80 with a documented diagnosis of PASC who have ongoing cognitive symptoms such as brain fog, are fluent in English, and on stable psychotropic medications if applicable.
Not a fit: People with a history of seizures, psychotic disorders, active substance dependence, implanted electrical devices, recent medical hospitalization, or those without cognitive complaints are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, this approach could reduce cognitive and mood symptoms of Long COVID and improve daily functioning and quality of life.
How similar studies have performed: Related rTMS/iTBS approaches have shown benefit for depression and some cognitive symptoms, but application to Long COVID is novel and supported only by limited preliminary data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Albuquerque, New Mexico
- University of New Mexico Health Science Center — Albuquerque, New Mexico, United States (Recruiting)
Study contacts
- Principal investigator: Davin Quinn, MD — University of New Mexico
- Study coordinator: Crystal Garcia
- Email: crabaca@salud.unm.edu
- Phone: 505-272-9552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.