Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
University of New Mexico
Study ID
NCT06940609
Phase
PHASE2
Status
Recruiting
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Conditions

  • Long COVID
  • Long COVID Syndrome
  • Long COVID-19 Syndrome
  • PASC
  • PASC Post Acute Sequelae of COVID 19

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • accelerated intermittent theta burst stimulation — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jul 7, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of New Mexico Health Science CenterAlbuquerqueNew Mexico87106
Crystal Garcia
[email protected]
505-272-9552
Davin Quinn, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Albuquerque, NM

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
University of New Mexico Health Science Center· Albuquerque, NM

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