Recruiting
Phase 2

iTBS

Sponsor:

University of New Mexico

Code:

NCT06940609

Conditions

Long COVID

Long COVID Syndrome

Long COVID-19 Syndrome

PASC

PASC Post Acute Sequelae of COVID 19

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

accelerated intermittent theta burst stimulation

Study Details

Brief summary:

The goal of this clinical trial is to test whether a type of rapid outpatient brain stimulation that uses magnetic fields, called accelerated intermittent theta burst stimulation (iTBS), can treat symptoms such as brain fog, depression, and anxiety in patients with Long COVID. The main questions it aims to answer are:

  • Is iTBS effective and feasible for reducing Long COVID symptoms? We will measure these symptoms using the Symptom Burden Questionnaire.
  • Are there changes in inflammatory brain chemicals associated with treatment with iTBS? We will be looking at levels of choline in the brain, which is thought to be related to inflammation.

Researchers will compare sham versus active forms of iTBS to see if the active group has greater improvement in symptoms.

Participants will complete symptom surveys, cognitive tests, and magnetic resonance imaging scans at the beginning, middle, and end of treatment.

Conditions

Long COVID

Long COVID Syndrome

Long COVID-19 Syndrome

PASC

PASC Post Acute Sequelae of COVID 19

Study ID

NCT06940609

Start date

Jul 7, 2025

Status verified date

Jul, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham accelerated iTBS

Sham stimulation is delivered using the same coil as active stimulation, producing an equivalent sound, however it is shielded so that no effective magnetic field reaches the participant's brain. To blind participants to active versus sham condition, a mild electrical skin stimulation that has no brain effects is delivered simultaneously with iTBS at the scalp to both active and sham groups, creating the same sense of skin sensation in both groups.

experimental: Active accelerated iTBS

Participants will be assigned to receive fMRI-guided iTBS (5 days, 5 sessions/day) to the left dorsolateral prefrontal cortex (dlPFC) during the sham-controlled phase. Each participant is invited to undergo 25 more sessions (5 more days) of open label, unblinded active accelerated fMRI-guided iTBS to the left dlPFC.

Interventions

accelerated intermittent theta burst stimulation

Intermittent theta burst stimulation (iTBS), a FDA-approved form of noninvasive neuromodulation, can reduce neuropsychiatric symptoms and modulate inflammation in the thalamus as detected using dMRS, suggesting a potentially effective and efficient treatment approach with a pathophysiological component that is readily quantifiable.

Primary outcome measure

  • Aim 1 [ Time Frame: From baseline to end of treatment at 2 weeks ]
  • Aim 2 [ Time Frame: From baseline to end of treatment at 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of New Mexico Health Science Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Principal Investigator:

Davin Quinn, MD

More Information

Sponsor

University of New Mexico

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of New Mexico on 2026-07-15.