Transcranial Magnetic Stimulation (TMS) to Treat Depression in Autism Spectrum Disorder

Yale University

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Device: MAGSTIM Rapid2 TMS system

Study type: Interventional

Funder types: Other

Identifiers

NCT06142955

2000035486

000

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 8 patient groups

ASD with depression, iTBS then Sham

Experimental group

Description:

Participants having ASD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart.

Treatment:

Device: MAGSTIM Rapid2 TMS system

ASD with depression, Sham then iTBS

Experimental group

Description:

Participants having ASD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session.Participants first received sham then iTBS approximately one week apart.

Treatment:

Device: MAGSTIM Rapid2 TMS system

ASD without depression, iTBS then Sham

Experimental group

Description:

Participants having ASD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart.

Treatment:

Device: MAGSTIM Rapid2 TMS system

ASD without depression, Sham then iTBS

Experimental group

Description:

Participants having ASD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session.Participants first received sham then iTBS approximately one week apart.

Treatment:

Device: MAGSTIM Rapid2 TMS system

TD with depression, iTBS then Sham

Experimental group

Description:

Participants that are TD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart.

Treatment:

Device: MAGSTIM Rapid2 TMS system

TD with depression, Sham then iTBS

Experimental group

Description:

Participants that are TD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received sham then iTBS approximately one week apart.

Treatment:

Device: MAGSTIM Rapid2 TMS system

TD without depression, iTBS then Sham

Experimental group

Description:

Participants that are TD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart.

Treatment:

Device: MAGSTIM Rapid2 TMS system

TD without depression, Sham then iTBS

Experimental group

Description:

Participants that are TD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received sham then iTBS approximately one week apart.

Treatment:

Device: MAGSTIM Rapid2 TMS system