Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of New Mexico

About this trial

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.

Eligibility criteria

Qualifiers

aged 18-80

a documented diagnosis of PASC with evidence of ongoing symptoms as demonstrated by score of 12 on the NIH RECOVER Symptom List

have "brain fog" or cognitive difficulties as one of the ongoing symptoms

are fluent in English

Disqualifiers

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;

history of a psychotic disorder, such as schizophrenia or bipolar disorder, so as to reduce risk of psychiatric decompensation

history of ongoing substance/alcohol dependence, to reduce confounding effects on diagnosis and brain imaging

presence of any implanted electrical device (e.g., pacemaker), to reduce risk of device malfunction from rTMS

Trial design

Treatments tested in this trial

  • accelerated intermittent theta burst stimulation

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of New Mexico

Lead sponsor

The Mind Research Network

Collaborator

United States Department of Defense

Collaborator