Clinical trial NCT05271357: Transcranial Magnetic Stimulation for Depression in Autism Spectrum Conditions
Official title: Theta Burst Stimulation for Refractory Depression in Autism Spectrum Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Major Depressive Disorder
Keywords: Transcranial magnetic stimulation
TMS
MDD
ASD
TBS
theta burst stimulation
autism
depression
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 17
Sex: ALL
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this research study the investigators aim to learn more about the therapeutic effects of a newer form of non-invasive transcranial magnetic stimulation (TMS), called theta burst simulation (TBS), on refractory depression in Autism Spectrum Conditions.

Detailed description: The overarching goal of this study is to examine treatment effects and elucidate the physiological biomarkers of a newer form of non-invasive brain stimulation therapy on refractory depression in a sample of participants with ASC (autism spectrum condition).

Aim 1: To compare the efficacy of 30-sessions of bilateral (BL) versus unilateral (UL) Theta Burst Stimulation to the dorsolateral prefrontal cortex (DLPFC) on depression severity in youth/young adults with ASC and co-occurring refractory major depressive disorder (MDD).

Aim 2: To identify physiological markers of target engagement of successful response to either UL or BL on depression severity in youth with ASC and co-occurring refractory MDD. These physiological markers include high-resolution electroencephalography (EEG) markers, social eye-tracking, and handgrip strength (collected via NIH toolbox's motor toolbox domain).

Aim 3: To identify feasibility of BL and UL in participants with ASC including systematic measures of safety and tolerability. This includes clinical measures such as rate of hospitalization and medication use.

Eligibility criteria: Inclusion Criteria:

* Have been diagnosed on the autism spectrum
* Have been diagnosed with depression and have failed one or more evidence-based antidepressant treatments (e.g. a Selective Serotonin Reuptake Inhibitor, talk therapy like Cognitive Behavioral Therapy)
* Do not have an intellectual disability

Exclusion Criteria:

* Substance use disorder
* Presence of metallic foreign bodies or implanted medical devices
* History of epilepsy
* Prior rTMS treatment
* For female subjects of child bearing potential, current pregnancy

Primary outcomes:
measure: Change-from-baseline at 4 weeks in mean Hamilton Depression Rating Scale (HDRS-17) score.
timeFrame: 4 weeks post-treatment
measure: Change-from-baseline at 4 weeks in mean and Beck Depression Inventory (BDI-II) scores.
timeFrame: 4 weeks post-treatment
Secondary outcomes:
measure: Change-from-baseline at 4 weeks in physiological markers via the use of high-resolution electroencephalography (EEG).
timeFrame: 4 weeks post-treatment
measure: Change-from-baseline at 4 weeks in handgrip strength or relative handgrip strength.
timeFrame: 4 weeks post-treatment
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Ernest Pedapati, MD
role: PRINCIPAL_INVESTIGATOR
References: