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

Официальное название

Neuromodulation for Depression in Autism Spectrum Disorder

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство MAGSTIM Rapid2 TMS system
  The device will administer TMS pulses in bursts at fixed intervals for a total of 600 pulses over 190 seconds after first assessing the participants motor threshold (MT). During the sham stimulation condition, the TMS coil will be tilted 90° tangential to the scalp during the administration so that the orientation is not biologically active and will not elicit a muscle contraction. This sham condition will look and sound just like real TMS.

Первичные конечные точки

• Change in Electroencephalogram (EEG) brain responses to sad faces [Срок оценки: baseline and up to week 2]
• Change in eye tracking (ET) to sad faces [Срок оценки: baseline and up to week 2]
• Change in Auditory Steady State Response (ASSR) [Срок оценки: baseline and up to week 2]

Вторичные конечные точки (4)

• Change in neural processing on EEG to sad faces [Срок оценки: baseline and up to week 2]
• Change in ET to different emotionally valenced faces [Срок оценки: baseline and up to week 2]
• Change in ET to neutral faces and non-social stimuli [Срок оценки: baseline and up to week 2]
• Change in Frith Happé Animations Task [Срок оценки: baseline and up to week 2]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Yale Psychiatric Hospital — New Haven

Идентификаторы

NCT: NCT06142955 · 2000035486 · 000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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