Clinical trial NCT03672266: Studies of Brain and Body Interaction
Official title: Studies of Brain and Body Interaction at Rutgers University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autistic Disorders Spectrum
Adhd
Asperger Syndrome
Alzheimer Disease
Parkinson
Tremor Essential
Dementia, Alzheimer Type
Lewy Body Dementia With Behavioral Disturbance (Disorder)
Dementia With Lewy Bodies
Dementia Frontal
Lead sponsor: Rutgers University
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: No restriction from which the cohort will be selected

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Unitless Stochastic Signatures of Biophysiological Signals, consisting of the Empirically Estimated Shape and Dispersion (scale) Parameters of Probability Distribution Functions
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Brain and Body Connectivity metrics and Derived Geometric and Topological Indexes from the Network Connectivity Model and Inverse Kinematic Model
timeFrame: through study completion, an average of 1 year
measure: Information theoretic metric
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
References: