Autism Spectrum DisorderNCT06807684
Abnormal Connectivity Involving the Social Reciprocity Network in Autism and the Impact of Neurostimulation in Mitigating the Abnormalities
A study testing transcranial magnetic stimulation in people with Autism Spectrum Disorder, run by Christiana Care Health Services at 1 site in United States.
Trial summary
There is no consensus regarding the neurological substrate underpinning ASD. The investigators describe the novel concept of "social reciprocity network" and hypothesize that aberrant connectivity/oscillatory patterns affecting this network contribute to the core deficits in ASD. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Fulfilling the DSM-V criteria for ASD and confirmed by CARS2, HF Exclusion criteria
- Patients with ASD exhibiting significant anxiety or contact avoidance, precluding them from cooperating with the procedure
- Patients with a known diagnosis of seizures
- Presence of any metallic implants or devices in the head or neck area
- Pregnant women
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Christiana Care
Newark, Delaware, 19718
Mitra Assadi, MD, 3026233017, mitra.assadi@christianacare.org
About this study
Official title: Discerning the Abnormal Functional Connectivity Involving the Social Reciprocity Network in Autism Spectrum Disorder and the Impact of Transcranial Magnetic Stimulation in Mitigating the Abnormalities
There is no consensus regarding the neurological substrate underpinning ASD. The investigators describe the novel concept of "social reciprocity network" and hypothesize that aberrant connectivity/oscillatory patterns affecting this network contribute to the core deficits in ASD.
The overarching goal of this trial is to explore abnormalities involving the neuronal connectivity and oscillatory patterns within the social reciprocity network and to elucidate the role of modulating this network via rTMS in improving the above measures and social cognition in ASD. Quantitative electroencephalography (QEEG) coherence and spectral power analysis are reliable measures of neuronal connectivity and dynamics. The investigators aim to study the QEEG coherence/spectral power analysis to explore the neuronal dynamics affecting the social reciprocity network in ASD.
Read the detailed description
Autism spectrum disorder (ASD) encompasses a range of limitations in reciprocal and communicative milestones, leading to significant functional challenges throughout the lifespan. While there is no consensus regarding the neuroanatomical substrate underpinning ASD, there are two major schools of thought: a group of researchers have focused on abnormalities affecting the mirror neurons and other cortical areas involved in social reciprocity, while others have proposed a more widespread alteration in neuronal organization in this condition resulting in abnormal white matter trajectories leading to cortical over or under connectivity. The investigators describe the social reciprocity network: the mirror neurons populated in the inferior frontal gyrus (IFG) and inferior parietal lobule (IPL), plus cortical areas involved in abstract social cognition including the medial prefrontal cortex, temporal-parietal junction and posterior cingulate gyrus. We hypothesize that aberrant connectivity affecting the above neuronal circuitry, "the social reciprocity network" contributes significantly to the core deficits in this condition.
Quantitative electroencephalography (QEEG) coherence and spectral power analysis are reliable measures of functional connectivity and neuronal dynamics. The investigators aim to study the QEEG coherence/spectral power analysis to explore the abnormal neuronal dynamics affecting the social reciprocity network in ASD. The existing literature suggest that noninvasive brain modulation, via Repetitive transcranial magnetic stimulation (rTMS), could potentially ameliorate the aberrant connectivity and the behaviors in ASD by altering neuronal dynamics. The investigator's overarching goal is to explore the neuronal connectivity in the social reciprocity network and to elucidate the mechanism of modulating these connections in improving social cognition in ASD.
Within this design, there are 3 aims:
Aim 1: Exploring the QEEG measures of connectivity and oscillatory patterns in the social reciprocity network in ASD. Hypothesis: abnormal connectivity affecting the social reciprocity network contributes to the core deficits in ASD.
Aim 2: Assessing the effects of rTMS of the bilateral social reciprocity network on the connectivity/spectral analysis as well as social cognition in ASD. Hypothesis: neurostimulation of the social reciprocity network ameliorates social cognition, power densities and the functional connectivity within the network.
- Conditions
- Autism Spectrum Disorder
- Being tested
- transcranial magnetic stimulation
- Keywords
- Autism spectrum, transcranial magnetic stimulation, neuronal connectivity
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
The investigators will deliver a type of high frequency rTMS known as intermittent theta burst stimulation (iTBS), 2400 stimulations per session, equally divided between the bilateral IPL and IFG.
| Study group | Role | What they receive |
|---|---|---|
| phase 1 | Sham comparator | During phase I (3 weeks), half of the subjects will receive rTMS, while the other half will receive sham stimulation. Receives: Device: transcranial magnetic stimulation |
| phase 2 | Active comparator | During phase II (3 weeks) all subjects will receive active stimulation. Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploring neuronal connectivity and oscillatory patterns in the social reciprocity network in ASD
Abnormal connectivity affecting the social reciprocity network contributes to the core deficits in ASD. The investigators will record an electroencephalogram (EEG) at baseline and after completing treatments with transcranial magnetic stimulation. The EEG data will be subjected to mathematical analysis in order to calculate measures of EEG coherence, functional connectivity and oscillatory patterns within the social reciprocity network. These numerical values will be used to discern:
- presence of a consistent pattern across the social reciprocity network at baseline for measurements of neuronal connectivity as well as the oscillatory patterns including alpha, beta, gamma, theta and mu rhythms
- improvement of the above neuronal connectivity and oscillatory patterns after the transcranial magnetic intervention
Measured: 9 weeks
Secondary outcomes (1)
Assessing the effects of iTBS stimulation of the bilateral social reciprocity network on social cognition in ASD
Presence and severity of autism spectrum disorder as assessed using the Childhood Autism Rating Scale, 2nd addition, high functioning.
The investigators hypothesize that iTBS of the social reciprocity network ameliorates social cognition in ASD. To measure the outcomes, the investigators will implement the Childhood Autism Rating Scale, 2nd addition, high functioning (CARS2, HF). This is a validated test that is based on actual measures of patient performance on behavioral tasks (score 30-37). The test is administered by a board-certified neuropsychologist before and after neurostimulation intervention. The test produces numerical values quantifying social cognition, reciprocity and rigid behaviors, comparing the results before and after the treatment to discern any potential efficacy.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start15 Aug 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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.
- 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
- Crossover
- Model description
- The investigators will recruit ASD cases 13-18 years of age and implementing 18 sessions (3 times/week for 6 weeks) of rTMS or sham stimulation of the bilateral IPL/IFG in a prospective, single blind study design. During phase I (3 weeks), half of the subjects will receive rTMS, while the other half will receive sham stimulation. During phase II (3 weeks) all subjects will receive active stimulation. The investigators will deliver a type of high frequency rTMS known as intermittent theta burst stimulation (iTBS), 2400 stimulations per session, equally divided between the bilateral IPL and IFG.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitra Assadi, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807684
- Sponsor's protocol ID
- DDD 605632
- Status last verified
- Feb 2025
- First submitted
- 12 Aug 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: we will enter all the data to the NIMH repository
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discerning the Abnormal Functional Connectivity Involving the Social Reciprocity Network in Autism Spectrum Disorder and the Impact of Transcranial Magnetic Stimulation in Mitigating the Abnormalities
- ClinicalTrials.gov ID
- NCT06807684
- Acronym / sponsor ID
- DDD 605632
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum, transcranial magnetic stimulation, neuronal connectivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Feb 2025 (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.
There is no consensus regarding the neurological substrate underpinning ASD. The investigators describe the novel concept of "social reciprocity network" and hypothesize that aberrant connectivity/oscillatory patterns affecting this network contribute to the core deficits in ASD.
The overarching goal of this trial is to explore abnormalities involving the neuronal connectivity and oscillatory patterns within the social reciprocity network and to elucidate the role of modulating this network via rTMS in improving the above measures and social cognition in ASD. Quantitative electroencephalography (QEEG) coherence and spectral power analysis are reliable measures of neuronal connectivity and dynamics. The investigators aim to study the QEEG coherence/spectral power analysis to explore the neuronal dynamics affecting the social reciprocity network in ASD.
Detailed description
Autism spectrum disorder (ASD) encompasses a range of limitations in reciprocal and communicative milestones, leading to significant functional challenges throughout the lifespan. While there is no consensus regarding the neuroanatomical substrate underpinning ASD, there are two major schools of thought: a group of researchers have focused on abnormalities affecting the mirror neurons and other cortical areas involved in social reciprocity, while others have proposed a more widespread alteration in neuronal organization in this condition resulting in abnormal white matter trajectories leading to cortical over or under connectivity. The investigators describe the social reciprocity network: the mirror neurons populated in the inferior frontal gyrus (IFG) and inferior parietal lobule (IPL), plus cortical areas involved in abstract social cognition including the medial prefrontal cortex, temporal-parietal junction and posterior cingulate gyrus. We hypothesize that aberrant connectivity affecting the above neuronal circuitry, "the social reciprocity network" contributes significantly to the core deficits in this condition.
Quantitative electroencephalography (QEEG) coherence and spectral power analysis are reliable measures of functional connectivity and neuronal dynamics. The investigators aim to study the QEEG coherence/spectral power analysis to explore the abnormal neuronal dynamics affecting the social reciprocity network in ASD. The existing literature suggest that noninvasive brain modulation, via Repetitive transcranial magnetic stimulation (rTMS), could potentially ameliorate the aberrant connectivity and the behaviors in ASD by altering neuronal dynamics. The investigator's overarching goal is to explore the neuronal connectivity in the social reciprocity network and to elucidate the mechanism of modulating these connections in improving social cognition in ASD.
Within this design, there are 3 aims:
Aim 1: Exploring the QEEG measures of connectivity and oscillatory patterns in the social reciprocity network in ASD. Hypothesis: abnormal connectivity affecting the social reciprocity network contributes to the core deficits in ASD.
Aim 2: Assessing the effects of rTMS of the bilateral social reciprocity network on the connectivity/spectral analysis as well as social cognition in ASD. Hypothesis: neurostimulation of the social reciprocity network ameliorates social cognition, power densities and the functional connectivity within the network.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will recruit ASD cases 13-18 years of age and implementing 18 sessions (3 times/week for 6 weeks) of rTMS or sham stimulation of the bilateral IPL/IFG in a prospective, single blind study design. During phase I (3 weeks), half of the subjects will receive rTMS, while the other half will receive sham stimulation. During phase II (3 weeks) all subjects will receive active stimulation. The investigators will deliver a type of high frequency rTMS known as intermittent theta burst stimulation (iTBS), 2400 stimulations per session, equally divided between the bilateral IPL and IFG.
| Arm | Type | Receives |
|---|---|---|
| phase 1 | Sham comparator | Device: transcranial magnetic stimulationDuring phase I (3 weeks), half of the subjects will receive rTMS, while the other half will receive sham stimulation. |
| phase 2 | Active comparator | Device: transcranial magnetic stimulationDuring phase II (3 weeks) all subjects will receive active stimulation. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 1. Fulfilling the DSM-V criteria for ASD and confirmed by CARS2, HF Exclusion criteria
- Patients with ASD exhibiting significant anxiety or contact avoidance, precluding them from cooperating with the procedure
- Patients with a known diagnosis of seizures
- Presence of any metallic implants or devices in the head or neck area
- Pregnant women
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| transcranial magnetic stimulationThe investigators will deliver a type of high frequency rTMS known as intermittent theta burst stimulation (iTBS), 2400 stimulations per session, equally divided between the bilateral IPL and IFG. | Device | phase 1, phase 2 |
Primary outcome
Exploring neuronal connectivity and oscillatory patterns in the social reciprocity network in ASD
Time frame: 9 weeks
Abnormal connectivity affecting the social reciprocity network contributes to the core deficits in ASD. The investigators will record an electroencephalogram (EEG) at baseline and after completing treatments with transcranial magnetic stimulation. The EEG data will be subjected to mathematical analysis in order to calculate measures of EEG coherence, functional connectivity and oscillatory patterns within the social reciprocity network. These numerical values will be used to discern: 1. presence of a consistent pattern across the social reciprocity network at baseline for measurements of neuronal connectivity as well as the oscillatory patterns including alpha, beta, gamma, theta and mu rhythms 2. improvement of the above neuronal connectivity and oscillatory patterns after the transcranial magnetic intervention
1 secondary outcome
Assessing the effects of iTBS stimulation of the bilateral social reciprocity network on social cognition in ASD
Time frame: 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: Yes. we will enter all the data to the NIMH repository
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Autism Spectrum Disorder, run by Christiana Care Health Services 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 5 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 21 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mitra Assadi, MD (3026233017, mitra.assadi@christianacare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploring neuronal connectivity and oscillatory patterns in the social reciprocity network in ASD (time frame: 9 weeks). 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 21 Feb 2025.