Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation (MANIFEST)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

• if taking psychotropic medications, have been on stable doses for the past month.

Locations
United States
New Mexico
University of New Mexico Health Science Center
RECRUITING
Albuquerque
Contact Information
Primary
Crystal Garcia
crabaca@salud.unm.edu
505-272-9552
Time Frame
Start Date: 2025-07-07
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense, The Mind Research Network
Leads: University of New Mexico

This content was sourced from clinicaltrials.gov