Autism Spectrum DisorderRESTORENCT05271357
Transcranial Magnetic Stimulation for Depression in Autism Spectrum Conditions
A study testing Bilateral TMS and Unilateral TMS in people with Autism Spectrum Disorder and Major Depressive Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 26 years
- Conditions the study is for
- Autism Spectrum Disorder, Major Depressive Disorder
- What is being tested?
- Bilateral TMS and Unilateral TMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2021to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Theta Burst Stimulation for Refractory Depression in Autism Spectrum Conditions
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.
Read the 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.
- Being tested
- Bilateral TMS, Unilateral TMS
- Keywords
- Transcranial magnetic stimulation, TMS, MDD, ASD, TBS, theta burst stimulation, autism, depression
- Medical subject headings
- Autism Spectrum Disorder, Depressive Disorder, Major, Autistic Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral TMSProcedure or surgery
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.
Unilateral TMSProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral | Experimental | Theta burst stimulation (TBS) Receives: Procedure: Bilateral TMS |
| Unilateral | Active comparator | Theta burst stimulation (TBS) Receives: Procedure: Unilateral TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks post-treatment
Secondary outcomes (2)
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.
Measured: 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.
Measured: 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start24 Nov 2021
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernest Pedapati, MD, Children's Hospital Medical Center, Cincinnati
- Investigators
- Ernest Pedapati, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271357
- Sponsor's protocol ID
- 2021-0594
- Acronym
- RESTORE
- Status last verified
- Feb 2024
- First submitted
- 28 Oct 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theta Burst Stimulation for Refractory Depression in Autism Spectrum Conditions
- ClinicalTrials.gov ID
- NCT05271357
- Acronym / sponsor ID
- RESTORE / 2021-0594
- Keywords
- Transcranial magnetic stimulation, TMS, MDD, ASD, TBS, theta burst stimulation, autism, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral | Experimental | Procedure: Bilateral TMSTheta burst stimulation (TBS) |
| Unilateral | Active comparator | Procedure: Unilateral TMSTheta burst stimulation (TBS) |
Who may qualify
- Ages
- 12 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral TMSStimulation 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. | Procedure or surgery | Bilateral |
| Unilateral TMSStimulation 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. | Procedure or surgery | Unilateral |
Primary outcome
Change-from-baseline at 4 weeks in mean Hamilton Depression Rating Scale (HDRS-17) score.
Time frame: 4 weeks post-treatment
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.
Change-from-baseline at 4 weeks in mean and Beck Depression Inventory (BDI-II) scores.
Time frame: 4 weeks post-treatment
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.
2 secondary outcomes
Change-from-baseline at 4 weeks in physiological markers via the use of high-resolution electroencephalography (EEG).
Time frame: 4 weeks post-treatment
Change-from-baseline at 4 weeks in handgrip strength or relative handgrip strength.
Time frame: 4 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest Pedapati, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral TMS and Unilateral TMS in people with Autism Spectrum Disorder and Major Depressive Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change-from-baseline at 4 weeks in mean Hamilton Depression Rating Scale (HDRS-17) score. (time frame: 4 weeks post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.