Clinical trial NCT06142955: Transcranial Magnetic Stimulation (TMS) to Treat Depression in Autism Spectrum Disorder
Official title: Neuromodulation for Depression in Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Academy of Child Adolescent Psychiatry.
First posted: 2023-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Typically developing (TD) controls and ASD participants with and without depression will receive both active and sham TMS in a randomized crossover assignment involving two study sessions.
Primary purpose: PREVENTION

Brief summary: This study will assess clinical and behavioral measures along with electroencephalogram (EEG), event-related potentials (ERPS), and eye-tracking (ET) prior to and following a single intermittent Theta Burst Stimulation (iTBS) session to provide preliminary insight into the potential of TMS as an intervention for depression in individuals with Autism Spectrum Disorder (ASD).

Detailed description: Participants will complete two separate sessions, approximately one week apart, with each session including: 1) a baseline assessment of neuropsychological, cognitive and behavioral function, 2) neural and visual attentional social response (EEG/ET paradigm), 3) a single iTBS session or sham stimulation to the left DLPFC, and 4) poststimulation assessment of neural and visual attentional social response (EEG/ET paradigm). The order of active stimulation versus sham will be randomized such that half of the participants in each group get the sham stimulation during the first session and half will get active stimulation in the first session then crossover. EEG and eye-tracking will take approximately 60-minutes and will be collected pre-and-post TMS administration.

Eligibility criteria: Inclusion Criteria:

* Individuals from Yale University and the surrounding community who are between the ages of 18 and 40 years old with or without a diagnosis of depression. Or individuals between the ages of 18 and 40 years old with a diagnosis of autism spectrum disorder, autistic disorder, PDD NOS, or Asperger syndrome with or without a diagnosis of depression.
* A depression score on the HDRS-17 of at least 20 will be used as a cut-off for depression.
* Participants are unmedicated or on stable medication treatment for at least two weeks.
* Willingness and ability to participate in an EEG and eye-tracking procedure.
* Provision of signed and dated informed consent.

Exclusion Criteria:

* Participants reporting significant head trauma or serious brain illness.
* Participants unable to provide signed informed consent.
* Participants with major psychiatric illness that would preclude completion of study measures. Participants with diagnosis of a psychotic or bipolar illness with be excluded.
* Participants with a history of serious medical illness, stroke, seizures, epileptiform EEG abnormalities, or family history of epilepsy.
* Participants taking prescription medications that may affect cognitive processes under study.
* Participants taking any medication that may increase their risk of seizures.
* Participants who have taken alcohol or recreational drugs within the preceding 24 hours prior to the scheduled study visit as determined by the urine toxicology test.
* Participants with a history of substance or alcohol abuse or dependence in the past 6 months.
* Participants with a significant risk of suicide or a h/o suicide attempt in the last 6 months. Participants with active suicidal ideation will be excluded from the study.
* Females of known/suspected pregnancy or who test positive on a pregnancy test.
* Participants with a history of metalworking or injury by shrapnel or metallic objects.
* Participants with a history of prior TMS therapy or use of an investigational drug within 12 weeks of visit
* Participants with an IQ below 80 (as confirmed by the WASI, Wechsler Abbreviated Scale of Intelligence)

Primary outcomes:
measure: Change in Electroencephalogram (EEG) brain responses to sad faces
timeFrame: baseline and up to week 2
measure: Change in eye tracking (ET) to sad faces
timeFrame: baseline and up to week 2
measure: Change in Auditory Steady State Response (ASSR)
timeFrame: baseline and up to week 2
Secondary outcomes:
measure: Change in neural processing on EEG to sad faces
timeFrame: baseline and up to week 2
measure: Change in ET to different emotionally valenced faces
timeFrame: baseline and up to week 2
measure: Change in ET to neutral faces and non-social stimuli
timeFrame: baseline and up to week 2
measure: Change in Frith Happé Animations Task
timeFrame: baseline and up to week 2
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Psychiatric Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Sherab Tsheringla, MD
role: PRINCIPAL_INVESTIGATOR
References: