RECRUITING

Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-07

Study Completion:2029-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06940609

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Crystal Garcia

CONTACT

505-272-9552

crabaca@salud.unm.edu

Principal Investigator

Davin Quinn, MD

PRINCIPAL_INVESTIGATOR

University of New Mexico

Study Locations (Sites)

University of New Mexico Health Science Center

Albuquerque, New Mexico, 87106

United States

Collaborators and Investigators

Sponsor: University of New Mexico

Davin Quinn, MD, PRINCIPAL_INVESTIGATOR, University of New Mexico

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-07

Study Completion Date2029-06-30

Study Record Updates

Study Start Date2025-07-07

Study Completion Date2029-06-30

Terms related to this study

Additional Relevant MeSH Terms

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