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

Posttraumatic Stress Disorder Clinical Trial

— MAGNETS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06449326
• Other study ID #: 23-451
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: October 1, 2027

Study information

• Verified date: June 2024
• Source: University of New Mexico
• Contact: Davin Quinn, MD
• Phone: 505-272-9494
• Email: dquinn[@]salud.unm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In MAGNETS, sixty-four participants will be recruited from the NMVAHCS PTSD programs, Polytrauma services, and outpatient mental health clinics. At study entry (Visit #1), participants will undergo baseline demographic, behavioral, and cognitive assessment, and fMRI and diffusion tensor imaging (DTI). The data analysis team will then determine the image-based target in the right hemisphere. Participants will be randomized to either the active (n=32) or sham (n=32) group and undergo 50 sessions of iTBS (10x/day, five days). At end of treatment (Visit #2), they will repeat all baseline tests, including fMRI. One-, three- and six-month symptom levels will be obtained through phone visits (Visits #3-5) to establish longevity and stability of benefit. Repeated measures analyses will be performed on behavioral and connectivity variables, with clinical (age, duration, head injury history) and imaging (white matter fiber counts) features as covariates.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Device:
• Active Intermittent theta burst stimulation
Intermittent theta burst stimulation (iTBS) is an efficient form of transcranial magnetic stimulation that allows up to 10x more pulses to be delivered in a given timeframe compared to conventional stimulation patterns.
• Sham Intermittent theta burst stimulation
Intermittent theta burst stimulation (iTBS) is an efficient form of transcranial magnetic stimulation that allows up to 10x more pulses to be delivered in a given timeframe compared to conventional stimulation patterns.

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System	Albuquerque	New Mexico
United States	UNM Center for Psychiatric Research	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	New Mexico VA Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AIM	Acceptability of Intervention Measure, a four-item measure of the acceptability of an intervention. It has five questions, scored on a 5-point Likert scale, from "completely disagree" to "completely agree"	Immediate post-treatment visit
Other	fMRI Connectivity	Connectivity between the dlPFC and vmPFC (range -1.0 to 1.0; higher scores indicate greater degree of positive correlation	Immediate post-treatment visit
Primary	CAPS-5	Clinician Administered PTSD Scale-DSM 5 (range 0-80; higher scores = more symptoms)	Immediate post-treatment visit
Secondary	PCL-5	PTSD Checklist-DSM 5 (range 0-80; higher scores = more symptoms)	Immediate post-treatment visit, 1 month, 3 months, 6 months
Secondary	PHQ-9	Patient Health Questionnaire-9 (range 0-27; higher scores = more symptoms)	Immediate post-treatment visit, 1 month, 3 months, 6 months
Secondary	GAD-7	Generalized Anxiety Disorder-7 (range 0-21; higher scores = more symptoms)	Immediate post-treatment visit, 1 month, 3 months, 6 months
Secondary	NSI	Neurobehavioral Symptom Inventory (range 0-88; higher scores = more symptoms)	Immediate post-treatment visit, 1 month, 3 months, 6 months
Secondary	DSM-XC (range 0-92; higher scores = more symptoms)	Diagnostic and Statistical Manual Cross-Cutting Assessment	Immediate post-treatment visit, 1 month, 3 months, 6 months
Secondary	WHODAS	World Health Organization Disability Assessment Schedule (range 0-100; higher scores = more disability)	Immediate post-treatment visit, 1 month, 3 months, 6 months
Secondary	PGIC	Patient Global Impression of Change (range 0-7; higher scores = more positive change)	Immediate post-treatment visit, 1 month, 3 months, 6 months