Autistic Disorders SpectrumNCT03672266
Studies of Brain and Body Interaction
An observational study of Autistic Disorders Spectrum and Adhd, run by Rutgers University at 1 site in United States.
Trial summary
The goal of this study is to characterize biophysiolgoical signals as a comprehensive profile of the nervous systems in order to understand interactions between the brain and body, while an individual performs naturalistic behaviors (ex. walking, pointing) and while breathing at a slow controlled pace. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Autistic Disorders Spectrum, Adhd, Asperger Syndrome
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 25 Dec 2025
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: No restriction from which the cohort will be selected
Who may be able to join
- Clinical diagnosis of any one of the following:
- Autism Spectrum Disorder(s)
- ADHD
- Asperger's syndrome
- Alzheimer's disease
- Fragile X syndrome
- Parkinson's disease
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers University
Piscataway, New Jersey, 08854-8020
About this study
Official title: Studies of Brain and Body Interaction at Rutgers University
The goal of this study is to characterize biophysiolgoical signals as a comprehensive profile of the nervous systems in order to understand interactions between the brain and body, while an individual performs naturalistic behaviors (ex. walking, pointing) and while breathing at a slow controlled pace. The investigators aim to study these interactions among a variety of populations, from healthy individuals to those with disorders such as Autism Spectrum Disorder(s), including those who may also have an ADHD (Attention-deficit/hyperactivity disorder) diagnosis, Asperger's Syndrome, Alzheimer's Disease, and/or Fragile X syndrome
Read the detailed description
What is the study for? The goal of this study is to characterize biophysical signals simultaneously co-registered from the person's nervous systems. To that end the investigators use multiple wearable biosensors (electroencephalogram, electrocardiogram, kinematics,etc.) and have the person move naturally during activities that are similar to what the person would do in activities of daily living. These include walking, walking with a metronome in the background and walking while breathing at the metronome's pace. The purpose of the study is to learn about the inherent properties of the biorhythms of each person in order to build a proper neurotypical scale and measure the departure of several groups of subjects from this typical ranges. These include Autism Spectrum Disorder(s), ADHD (Attention-deficit/hyperactivity disorder) , Asperger's Syndrome, Alzheimer's Disease, and/or Fragile X syndrome. This study does not provide any recommendations of diagnosis or treatment. It is merely a characterization of the person's biorhythms across these conditions.
What will the participant do? The participant will perform naturalistic behaviors (ex. walk naturally around the room, point at an object) while hearing a metronome beating in the background. At certain points, the participant will be instructed to breathe along with the beat of the metronome. During this experiment, the participant will be wearing a wireless Electroencephalographic (EEG) cap to record brain activity, wireless motion sensors around the body to record movement, and wireless electrocardiogram (ECG) on the chest to record heart activity.The participant will also be wearing Zeblok insoles placed inside their shoes, to monitor their gait. The recorded biophysical signals are to be used to assess biorhythms of the nervous system from an already diagnosed participants and neurotypical participants, as this experiment is designed to study and characterize the biophysical signals of various populations. The study does not provide criteria for diagnosis, nor does it provide recommendations for treatments. The study is merely characterizing the ranges of biophysical data and their variability across different populations to measure departure from neurotypical features. Please note, wearing a wireless EEG cap will involve applying electrode gel (similar to hair gel) on the participant's hair.
How long is the experiment? The experiment itself will take 45 minutes - comprising 3 walking trials lasting 15 minutes each - but this can be reduced depending on the participant's disposition. Breaks for light refreshments and sensory toys will be provided as needed. The setup will take an additional 15-30 minutes.
Where/when does the experiment take place? The experiment will be conducted at the Sensory-motor Integration Lab, Psychology Building on Busch campus, at Rutgers University (152 Frelinghuysen Road, Piscataway, NJ 08854). If necessary the experiment may also be conducted at the participant's home. Based on the availability of the participant and the experimenter, the date and place can be coordinated any day and time of the week - including weekends. Additional members of staff can provide on-site childcare for siblings upon request.
- Conditions
- Autistic Disorders Spectrum, Adhd, Asperger Syndrome, Alzheimer Disease, Parkinson, Tremor Essential
- Medical subject headings
- Child Development Disorders, Pervasive, Attention Deficit Disorder with Hyperactivity, Asperger Syndrome, Alzheimer Disease, Essential Tremor, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neurological Disorder | Individuals with neurological disorders such as Autism Spectrum Disorder(s), including those who may also have an ADHD diagnosis, Asperger's Syndrome, Alzheimer's Disease, Fragile X syndrome, Parkinson's disease, Lewy Body Dementia, and/or Frontoparietal Dementia | |
| Neurotypical | Healthy individuals with no known neurological disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unitless Stochastic Signatures of Biophysiological Signals, consisting of the Empirically Estimated Shape and Dispersion (scale) Parameters of Probability Distribution Functions
Biophysical signals extracted from the brain and heart (mV) and motor kinematics (m/s) activities will be normalized and scaled to a unit-less waveform dataset. The standardized unitless data set will account for anatomical differences and will then be empirically characterized as families of probability distributions for each person, by the shape and scale parameters of continuous families of probability distribution functions with variable shapes and dispersion (noise to signal ratio). These parameters are objective biomarkers for a variety of disorders, and inform the level of noise-to-signal ratio and predictability of an individual's biorhythms (Torres, 2018).
Torres, E. (2018). Objective Biometric Methods for the Diagnosis and Treatment of Nervous Systems Disorder: Elsevier
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Brain and Body Connectivity metrics and Derived Geometric and Topological Indexes from the Network Connectivity Model and Inverse Kinematic Model
Based on a mathematical network connectivity model (Rubinov and Sporns, 2010), the investigators will measure how the brain and body (central and peripheral networks) interact while participants perform naturalistic tasks. Based on the physiological data from the brain and heart activities (mV) and motor kinematics (m/s), the experimental analytics provide a model that measures unit-less connectivity measures between different parts of the body. Namely, they are degrees (i.e., number of links connected to a node), shortest path length (a basis for measuring integration), number of triangles (a basis for measuring segregation), and modularity. Further, analyzes of forward and inverse kinematics dynamics will be derived from the three dimensional positional and orientation data of the kinematic sensors along with the person's mass and bone-length data, using state of the art models of inverse dynamics (Torres, 2001).
Measured: through study completion, an average of 1 year
Information theoretic metric
Based on an information theoretic model (Shannon,1956), the investigators will quantify the probability distribution function of measured biophysical signals from the brain and heart (mV) and kinematics (m/s), and characterize information passing across the central and peripheral nervous systems, including as well the autonomic nervous system.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Aug 2018
- Primary completion1 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic Disorders SpectrumStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth B. Torres Ph.D., Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672266
- Sponsor's protocol ID
- BrainBody
- Status last verified
- Oct 2025
- First submitted
- 7 Sep 2018
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Brain and Body Interaction at Rutgers University
- ClinicalTrials.gov ID
- NCT03672266
- Acronym / sponsor ID
- BrainBody
- Conditions
- Autistic Disorders Spectrum, Adhd, Asperger Syndrome, Alzheimer Disease, Parkinson, Tremor Essential
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rutgers UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 14 Sep 2018 (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.
The goal of this study is to characterize biophysiolgoical signals as a comprehensive profile of the nervous systems in order to understand interactions between the brain and body, while an individual performs naturalistic behaviors (ex. walking, pointing) and while breathing at a slow controlled pace. The investigators aim to study these interactions among a variety of populations, from healthy individuals to those with disorders such as Autism Spectrum Disorder(s), including those who may also have an ADHD (Attention-deficit/hyperactivity disorder) diagnosis, Asperger's Syndrome, Alzheimer's Disease, and/or Fragile X syndrome
Detailed description
What is the study for? The goal of this study is to characterize biophysical signals simultaneously co-registered from the person's nervous systems. To that end the investigators use multiple wearable biosensors (electroencephalogram, electrocardiogram, kinematics,etc.) and have the person move naturally during activities that are similar to what the person would do in activities of daily living. These include walking, walking with a metronome in the background and walking while breathing at the metronome's pace. The purpose of the study is to learn about the inherent properties of the biorhythms of each person in order to build a proper neurotypical scale and measure the departure of several groups of subjects from this typical ranges. These include Autism Spectrum Disorder(s), ADHD (Attention-deficit/hyperactivity disorder) , Asperger's Syndrome, Alzheimer's Disease, and/or Fragile X syndrome. This study does not provide any recommendations of diagnosis or treatment. It is merely a characterization of the person's biorhythms across these conditions.
What will the participant do? The participant will perform naturalistic behaviors (ex. walk naturally around the room, point at an object) while hearing a metronome beating in the background. At certain points, the participant will be instructed to breathe along with the beat of the metronome. During this experiment, the participant will be wearing a wireless Electroencephalographic (EEG) cap to record brain activity, wireless motion sensors around the body to record movement, and wireless electrocardiogram (ECG) on the chest to record heart activity.The participant will also be wearing Zeblok insoles placed inside their shoes, to monitor their gait. The recorded biophysical signals are to be used to assess biorhythms of the nervous system from an already diagnosed participants and neurotypical participants, as this experiment is designed to study and characterize the biophysical signals of various populations. The study does not provide criteria for diagnosis, nor does it provide recommendations for treatments. The study is merely characterizing the ranges of biophysical data and their variability across different populations to measure departure from neurotypical features. Please note, wearing a wireless EEG cap will involve applying electrode gel (similar to hair gel) on the participant's hair.
How long is the experiment? The experiment itself will take 45 minutes - comprising 3 walking trials lasting 15 minutes each - but this can be reduced depending on the participant's disposition. Breaks for light refreshments and sensory toys will be provided as needed. The setup will take an additional 15-30 minutes.
Where/when does the experiment take place? The experiment will be conducted at the Sensory-motor Integration Lab, Psychology Building on Busch campus, at Rutgers University (152 Frelinghuysen Road, Piscataway, NJ 08854). If necessary the experiment may also be conducted at the participant's home. Based on the availability of the participant and the experimenter, the date and place can be coordinated any day and time of the week - including weekends. Additional members of staff can provide on-site childcare for siblings upon request.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurological Disorder | – | –Individuals with neurological disorders such as Autism Spectrum Disorder(s), including those who may also have an ADHD diagnosis, Asperger's Syndrome, Alzheimer's Disease, Fragile X syndrome, Parkinson's disease, Lewy Body Dementia, and/or Frontoparietal Dementia |
| Neurotypical | – | –Healthy individuals with no known neurological disorders |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- No restriction from which the cohort will be selected
Key inclusion criteria (7 listed)
- Autism Spectrum Disorder(s)
- ADHD
- Asperger's syndrome
- Alzheimer's disease
- Fragile X syndrome
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Unitless Stochastic Signatures of Biophysiological Signals, consisting of the Empirically Estimated Shape and Dispersion (scale) Parameters of Probability Distribution Functions
Time frame: through study completion, an average of 1 year
Biophysical signals extracted from the brain and heart (mV) and motor kinematics (m/s) activities will be normalized and scaled to a unit-less waveform dataset. The standardized unitless data set will account for anatomical differences and will then be empirically characterized as families of probability distributions for each person, by the shape and scale parameters of continuous families of probability distribution functions with variable shapes and dispersion (noise to signal ratio). These parameters are objective biomarkers for a variety of disorders, and inform the level of noise-to-signal ratio and predictability of an individual's biorhythms (Torres, 2018). Torres, E. (2018). Objective Biometric Methods for the Diagnosis and Treatment of Nervous Systems Disorder: Elsevier
2 secondary outcomes
Brain and Body Connectivity metrics and Derived Geometric and Topological Indexes from the Network Connectivity Model and Inverse Kinematic Model
Time frame: through study completion, an average of 1 year
Information theoretic metric
Time frame: through study completion, an average of 1 year
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 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autistic Disorders Spectrum and Adhd, run by Rutgers University 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 7 inclusion and 1 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 29 Apr 2026. 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?
Unitless Stochastic Signatures of Biophysiological Signals, consisting of the Empirically Estimated Shape and Dispersion (scale) Parameters of Probability Distribution Functions (time frame: through study completion, an average of 1 year). 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 29 Apr 2026.