Using MRI and TMS to understand catatonia in autism

Use of Magnetic Resonance Imaging and Continuous Theta Burst Stimulation for Catatonia in Autism

This study is testing how brain activity relates to catatonia symptoms in young people with autism to find better ways to diagnose and treat this condition.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 15 Years to 40 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06016764 on ClinicalTrials.gov

What this trial studies

This study aims to explore the relationship between brain hyper-excitability and symptoms of catatonia in individuals with Autism Spectrum Disorder (ASD). Participants aged 15-40 will undergo brain imaging and receive continuous theta burst stimulation to target the primary motor strip. The goal is to identify potential biomarkers for catatonia and assess how these correlate with social-emotional impairments in autism. This research could pave the way for new diagnostic and therapeutic approaches for managing catatonia in autistic individuals.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 15-40 diagnosed with Autism Spectrum Disorder who can assent to the study.

Not a fit: Patients with a history of substance abuse, major medical or neurological illnesses, or recent seizures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic methods and targeted treatments for catatonia in individuals with autism.

How similar studies have performed: While this approach is novel in its specific focus on catatonia in autism, similar studies using brain imaging and stimulation techniques have shown promise in other neurological conditions.

Eligibility criteria

Inclusion criteria:

* Individuals aged 15-40 years of age will be enrolled. This age range was selected given the high degree of social development occurring in this life stage, the developmental nature of ASD, and ongoing cTBS-induced changes in MEP amplitude observed in AIC individuals as they age.
* Subjects and/or guardians must also be fluent in English, diagnosed with ASD based on DSM-5 criteria1 and Autism Diagnostic Observation Schedule-II (ADOS-II) assessment,78 and competent to assent to the study based on investigator clinical evaluation. Consenting guardians will be included if indicated.
* Subjects, or guardians if subjects cannot consent, must be competent to consent to the study. Subjects must be able to assent to the study as determined by clinical evaluation from the primary investigator.

Exclusion Criteria:

* History of substance abuse/dependence,
* History of concomitant major medical/neurologic illness
* History of seizure within one calendar year
* History of traumatic brain injury
* Pregnant or currently breastfeeding
* Are psychiatrically or medically unstable as determined by the investigator clinical evaluation
* Prescribed medication contraindicated in TMS
* Have a history of TMS treatment.
* Are diagnosed with a syndrome which results in ASD symptoms as preliminary research suggests individuals with these diagnoses have differing biomarker responses to TMS.26
* Children below the age of fifteen will also be excluded because of decreased likelihood of remaining still in the MRI scanner, as well as for scientific reasons surrounding unknown variability for key variables during pubertal onset.
* MRI scanning also introduces exclusionary criteria for conditions contraindicated to MRI, thus individuals with any bodily metal, history of claustrophobia, or pacemakers will be excluded.
* Expresses dissenting behaviors as outlined below.

Where this trial is running

Nashville, Tennessee

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Joshua R Smith

Conditions Autism Spectrum Disorder; Catatonia; Intellectual Disability