An interventional study of Bilateral TMS and Unilateral TMS in Autism Spectrum Disorder and Major Depressive Disorder, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 12 Years to 26 Years. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 17 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 132 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
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Exclusion Criteria:
Theta burst stimulation (TBS)
Procedure: Bilateral TMS
Theta burst stimulation (TBS)
Procedure: Unilateral TMS
Stimulation begins with continuous TBS to the right dorsolateral prefrontal cortex (DLPFC) (120 seconds of uninterrupted bursts; 600 pulses per session) followed by intermittent TBS to the left DLPFC (2 seconds on and 8 seconds off; 600 pulses per session); total duration of 3 min 9 seconds per hemisphere.
Stimulation involves only intermittent TBS to the left DLPFC (2 seconds on and 8 seconds off; 600 pulses per session); total duration of 3 min 9 seconds.
Change-from-baseline at 4 weeks in mean Hamilton Depression Rating Scale (HDRS-17) score.
The HDRS-17 is a valid and reliable measure that assesses severity of, and change in, depressive symptoms. HDRS-17 scores range from 0-52, with scores of 0-7 indicating absence or remission of depression, 7-17 indicating mild depression, 18-24 indicating moderate depression, and scores at or over 25 indicating severe depression.
Time frame: 4 weeks post-treatment
Change-from-baseline at 4 weeks in mean and Beck Depression Inventory (BDI-II) scores.
The BDI-II is a valid and reliable measure for assessing the severity of depressive symptoms. BDI-II scores range from 0-63, with scores of 0-10 indicating absence or remission of depression, 11-16 indicating mild mood disturbance, 17-20 indicating borderline clinical depression, 21-30 indicating moderate depression, 31-40 severe depression, and scores over 40 indicating extreme depression.
Time frame: 4 weeks post-treatment
Change-from-baseline at 4 weeks in physiological markers via the use of high-resolution electroencephalography (EEG).
EEG offers a real-time image of cortical excitability and connectivity. We will use power spectral analysis to assess changes in event-related gamma and alpha activity.
Time frame: 4 weeks post-treatment
Change-from-baseline at 4 weeks in handgrip strength or relative handgrip strength.
Handgrip strength is particularly novel and has been shown to be negatively associated with depressive symptoms, making muscle strength a possible clinical marker of poor mental health. The grip strength test from NIH Toolbox's motor domain will be used to collect a digital reading of force in pounds from each participant.
Time frame: 4 weeks post-treatment
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — all collected IPD
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati