Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
ID06940609

Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation (MANIFEST) for Long COVID Brain Symptoms

Led by University of New Mexico · Updated on 2025-07-15

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of New Mexico

Lead Sponsor

T

The Mind Research Network

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate whether accelerated intermittent theta burst stimulation (iTBS), a rapid outpatient brain stimulation using magnetic fields, can improve symptoms like brain fog, depression, and anxiety in adults with Long COVID. The study is a randomized, sham-controlled trial designed to assess the effectiveness and feasibility of iTBS in reducing these symptoms while also investigating changes in brain inflammation markers, specifically choline levels. Participants will receive either active or sham iTBS targeted to the left dorsolateral prefrontal cortex using fMRI guidance. The treatment consists of 5 sessions per day over 5 days during the blinded phase, followed by an open-label phase with 25 more active sessions over 5 days. Sham stimulation mimics the sound and sensation of active treatment without delivering magnetic fields. A mild electrical skin stimulation is used in both groups to maintain blinding. During the study, participants will complete symptom questionnaires, cognitive tests, and magnetic resonance imaging scans at baseline, mid-treatment, and end of treatment. Researchers will monitor symptoms, mood, anxiety, cognition, and quality of life, correlating improvements with imaging and clinical data. The main outcomes are measured from baseline to the end of the 2-week treatment period.

CONDITIONS

Brief Title

Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 80 years
  • Documented diagnosis of post-acute sequelae of COVID-19 (PASC) with ongoing symptoms shown by a score of 12 on the NIH RECOVER Symptom List
  • Experiencing brain fog or cognitive difficulties as continuing symptoms
  • Fluent in English
  • If taking psychotropic medications, doses must be stable for at least one month
Not Eligible

You will not qualify if you...

  • History of other neurological diseases or seizures
  • History of psychotic disorders like schizophrenia or bipolar disorder
  • Ongoing substance or alcohol dependence
  • Presence of any implanted electrical device such as a pacemaker
  • Recent medical hospitalization within four weeks
  • Any condition preventing completion of the study protocol
  • Appointment of a legal representative
  • Ongoing litigation related to medical diagnosis or disability
  • Contraindication to MRI
  • Membership in a vulnerable population including minors, pregnant women, and prisoners

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 weeks

Participants receive either active or sham accelerated intermittent theta burst stimulation (iTBS) to the brain target over 5 days with 5 sessions each day during the blinded phase, followed by 5 more days of open-label active iTBS.

5 daily sessions per week for 2 weeks

Trial Site Locations

Total: 1 location

1

University of New Mexico Health Science Center

Albuquerque, New Mexico, United States, 87106

Actively Recruiting

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Research Team

C

Crystal Garcia

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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