RECRUITING

Multimodal Image Analysis and Guidance of Neuromodulation for Trauma-Related Symptoms

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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

MAGNETS is a prospective, randomized, parallel-design, sham-controlled clinical trial of accelerated, functional magnetic resonance imaging (fMRI)-guided intermittent theta burst stimulation (iTBS) to the right dorsolateral prefrontal cortex (dlPFC) for chronic symptoms of posttraumatic stress disorder (PTSD) in a comorbid Veteran population.

Official Title

Multimodal Image Analysis and Guidance of Neuromodulation for Trauma-Related Symptoms

Quick Facts

Study Start:2024-06-01

Study Completion:2027-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06449326

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
* Veterans will be enrolled in this study if they: 1. are aged 18-80; 2. have a documented diagnosis of PTSD with evidence of ongoing symptoms as demonstrated by score of "31" or higher on the PCL-5, a measure of posttraumatic stress symptoms; 3. are fluent in English (as the neuropsychological testing tools used are only available in English) and 4. have been on stable doses of psychotropic medications for the past month.	* Veterans will be excluded from participation in this study if there is: 1. a prior history of other neurological disease beyond mild TBI, as determined by VA/DoD criteria for TBI severity; 2. any history of seizures beyond immediate posttraumatic seizure or childhood febrile seizure, so as to reduce risk of exacerbation of epilepsy or other neurological symptoms; 3. history of a psychotic disorder, such as schizophrenia or bipolar disorder, so as to reduce risk of psychiatric decompensation; 4. active substance/alcohol dependence without ongoing treatment, to reduce confounding effects on diagnosis and brain imaging; 5. presence of any implanted electrical device (e.g., pacemaker), to reduce risk of device malfunction from rTMS; 6. recent medical hospitalization (within four weeks), to reduce risk of medical decompensation during the study; 7. any condition that would prevent the subject from completing the protocol; 8. appointment of a legal representative or inability to provide informed consent, to avoid coercion of a vulnerable population; 9. any ongoing litigation related to PTSD, TBI, disability determination, or service connection, to prevent interference with legal proceedings; 10. any contraindication to MRI; 11. pregnant women, so as to prevent complications; 12. membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion; 13. Cognitively impaired adults who lack capacity to consent.

Inclusion Criteria

Exclusion Criteria

* Veterans will be enrolled in this study if they:
1. are aged 18-80;
2. have a documented diagnosis of PTSD with evidence of ongoing symptoms as demonstrated by score of "31" or higher on the PCL-5, a measure of posttraumatic stress symptoms;
3. are fluent in English (as the neuropsychological testing tools used are only available in English) and
4. have been on stable doses of psychotropic medications for the past month.

* Veterans will be excluded from participation in this study if there is:
1. a prior history of other neurological disease beyond mild TBI, as determined by VA/DoD criteria for TBI severity;
2. any history of seizures beyond immediate posttraumatic seizure or childhood febrile seizure, so as to reduce risk of exacerbation of epilepsy or other neurological symptoms;
3. history of a psychotic disorder, such as schizophrenia or bipolar disorder, so as to reduce risk of psychiatric decompensation;
4. active substance/alcohol dependence without ongoing treatment, to reduce confounding effects on diagnosis and brain imaging;
5. presence of any implanted electrical device (e.g., pacemaker), to reduce risk of device malfunction from rTMS;
6. recent medical hospitalization (within four weeks), to reduce risk of medical decompensation during the study;
7. any condition that would prevent the subject from completing the protocol;
8. appointment of a legal representative or inability to provide informed consent, to avoid coercion of a vulnerable population;
9. any ongoing litigation related to PTSD, TBI, disability determination, or service connection, to prevent interference with legal proceedings;
10. any contraindication to MRI;
11. pregnant women, so as to prevent complications;
12. membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion;
13. Cognitively impaired adults who lack capacity to consent.

Contacts and Locations

Study Contact

Davin Quinn, MD

CONTACT

505-272-9494

dquinn@salud.unm.edu

Study Locations (Sites)

UNM Center for Psychiatric Research

Albuquerque, New Mexico, 87106

United States

New Mexico VA Health Care System

Albuquerque, New Mexico, 87108

United States

Collaborators and Investigators

Sponsor: 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 Date2024-06-01

Study Completion Date2027-10-01

Study Record Updates

Study Start Date2024-06-01

Study Completion Date2027-10-01

Terms related to this study

Additional Relevant MeSH Terms

Posttraumatic Stress Disorder