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

Launched by UNIVERSITY OF NEW MEXICO · Jun 5, 2024

Keywords

ClinConnect Summary

The MAGNETS clinical trial is studying a new treatment approach for veterans suffering from Posttraumatic Stress Disorder (PTSD). Specifically, it focuses on using a technique called intermittent theta burst stimulation (iTBS) guided by advanced brain imaging to help improve ongoing PTSD symptoms. The trial is currently recruiting participants aged 18 to 80 who have a confirmed diagnosis of PTSD and are experiencing significant symptoms. To be eligible, veterans must also be fluent in English and have stable medication dosages for the past month.

Participants in this study can expect to undergo brain scans and receive treatment to see if this new method can help reduce their PTSD symptoms. It's important to note that certain individuals, such as those with severe neurological issues or recent hospitalizations, may not be eligible to participate. The goal of this trial is to find effective new ways to help veterans manage their PTSD symptoms, and we hope to gather valuable insights that can improve treatment options in the future.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• * 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.