ASDRETSORE-RCTNCT06670040
Theta Burst Stimulation for Refractory Depression in Autism Spectrum Disorder
A study testing Transcranial Magnetic Stimulation in people with ASD and Autism Spectrum Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD) Read more about this study
- Who is it for?
- Ages 13 to 26 years
- Conditions the study is for
- ASD, Autism Spectrum Disorder, Autism
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 30 May 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Fluent in English and able to volunteer in the informed consent process and provide spontaneous narrative description of key elements, risks, and benefits of the study.
- Aged 13-26, inclusive.
- Full-scale intelligence quotient ≥ 70.
- Diagnosis of ASD using criteria from Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Diagnosis will be confirmed by study psychologist/social worker and supported by scoring in the ASD on the Autism Diagnostic Observation Schedule (ADOS-2).
- Diagnosis of MDD based on psychologist diagnosis and DSM-5-based structural diagnostic interview determine via KSADS
- Exhibiting treatment resistance to at least one antidepressant drug treatment of adequate dose and duration.
- Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale ≥ 20 which must be maintained through lead-in period.
- Participants are not required to discontinue current interventions but must agree to attempt to keep medications and other interventions stable during the study.
Who cannot join
- Participation in an investigational drug trial within the past three months.
- Active substance use disorder (excluding tobacco use) within the past 6 months.
- Contraindications to Transcranial Magnetic Stimulation including, but not limited to, a history of epilepsy, the presence of metallic foreign bodies, or implanted medical devices (e.g. pacemaker, medical pump).
- Actively suicidal (i.e., suicidal ideation with plan and intent) or deemed at high risk for suicide.
- Current use of anticonvulsant, barbiturate, lithium, or benzodiazepine medications.
- Prior rTMS treatment.
- For female subjects of childbearing potential, a positive urine pregnancy test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45224
About this study
Official title: Sham-Controlled rTMS for Refractory Depression in Autism Spectrum Disorder
Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD)
Read the detailed description
The overall goal of this study is to treat major depressive disorder (MDD) rapidly and effectively in individuals with autism spectrum disorder (ASD). Our central hypothesis is that accelerated theta burst stimulation (aTBS) targeting the left dorsal lateral prefrontal cortex (DLPFC) will significantly improve MDD symptoms and rate of remission compared to sham. We propose a double-blind RCT of 13-to 26-year-old individuals with ASD with MDD to test the efficacy of aTBS (n=12) versus sham (n=12) treatment. Participants will be rigorously characterized, including co-occurring conditions, any concurrent therapies, medications, social function, cognition, and sensory profile. A core battery of assessments will assess the efficacy of the intervention and maintenance of gains with respect to MDD and ASD-specific symptomology. Neural target engagement will be assessed by source-localized Electroencephalography (EEG) connectivity.
- Being tested
- Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation Sham
- Keywords
- ASD, Autism, Autism Spectrum Disorder, MDD, Depression, TMS, TBS, Transcranial Magnetic Stimulation, Theta Burst Stimulation, Major Depressive Disorder
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationProcedure or surgery
All TBS sessions will be delivered at the same site, intensity (up to 90% RMT), pattern and duration. Treatment conditions differ only in the amount of intracranial activation induced (i.e., negligible activation in sham condition). TBS sessions consist of triplet 50 Hz bursts repeated every 200 msec (5 Hz), delivered to the left DLPFC in an intermittent (2 seconds on/8 seconds off) pattern for a total of 600 pulses per session; duration of 3 minutes 9 seconds.
Transcranial Magnetic Stimulation ShamProcedure or surgery
We will use a robust sham technique that suitably replicates the sensory experience (auditory and peripheral activation) of active TBS with minimal intracranial activation. The Magstim Horizon™ sham coil will be utilized for treatment delivery. This sham coil is visually identical to the active coil and replicates the sounds and sensation of the magnetic stimulation. All sham treatment will be delivered at the same site, intensity (up to 90% RMT), pattern and duration. Treatment conditions differ only in the amount of intracranial activation induced (i.e., negligible activation in sham condition). TBS sessions consist of triplet 50 Hz bursts repeated every 200 msec (5 Hz), delivered to the left DLPFC in an intermittent (2 seconds on/8 seconds off) pattern for a total of 600 pulses per session; duration of 3 minutes 9 seconds
| Study group | Role | What they receive |
|---|---|---|
| Sham controlled | Sham comparator | Sham aTBS targeting the left dorsolateral prefrontal cortex, 5 sessions per day for 5 days. If participants in the sham group do not show a significant treatment response by the 12-week follow-up - defined as a 50% reduction from baseline on the HDRS- they will then become eligible for and offered active, open-label treatment. Receives: Procedure: Transcranial Magnetic Stimulation Sham |
| Active TBS Treatment | Active comparator | Active aTBS targeting the left dorsolateral prefrontal cortex, 5 sessions per day for 5 days. Receives: Procedure: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-item Hamilton Rating Scale for Depression (HDRS)
The HDRS is a 17-item rating scale administered by a trained rater following a semi-structured interview. Scores of 0-7 are generally within the normal range, and a score of 20 or higher indicates moderate depression severity. Research suggests that a decrement of 7 points on the HAMD-17 represents minimally clinically important differences from patient perspectives. HDRS will be assessed at screening, baseline and all follow up visits.
Measured: Completed at Screening, baseline, 2-week, 6-week, and 12-week follow up
NIH Toolbox Cognition Battery
The NIH Toolbox was designed to serve as a brief, convenient set of measures to supplement other outcome measures in epidemiologic and longitudinal research and clinical trials.
Measured: Completed at Screening, 2-week, 6-week, and 12-week follow up
Secondary outcomes (1)
Electroencephalography (EEG)
Recordings are acquired using a gel-based electrode setup with a Biosemi EEG system, featuring 64 channels. Data are recorded at a sampling rate of 256 Hz, utilizing gel-based electrodes that enhance conductivity and minimize noise. This configuration ensures high-quality signal acquisition, enabling precise analysis of brain responses to various stimuli. 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.
Measured: Completed at baseline, 2-week, 6-week, and 12-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start16 Sep 2024
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It's a randomized controlled trial with active accelerated Theta Burst Stimulation (aTBS) treatment and sham controlled group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Elmaghraby, Children's Hospital Medical Center, Cincinnati
- Investigators
- Rana Elmaghraby, MD, Principal investigator, Cincinnati Childrens Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670040
- Sponsor's protocol ID
- 2023-0682
- Acronym
- RETSORE-RCT
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the IPD collected throughout this trial