Clinical trial NCT04526600: Fidgeting and Attentional and Emotional Regulation in ADHD
Official title: Can Fidgeting Lead to Enhanced Attention and Emotional Regulation in ADHD?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This project will study how fidgeting relates to cognitive and emotional functioning in adults with attention-deficit/hyperactivity disorder (ADHD). It will determine, in a laboratory setting, whether movement and access to a "fidget device" providing sensory and motor stimulation can improve cognitive and emotional regulation (including on physiological measures) in adult ADHD. The investigators will also acquire pilot data for machine learning analyses to be used in future, large scale studies to identify gestures and touch characteristics associated with improved cognitive and emotional regulation to see if the data can predict and subsequently develop recommendations to improve performance and emotional control in natural settings (e.g., home, office, college classroom) for adult ADHD.

Detailed description: Fidgeting is a highly common behavior, with excessive fidgeting associated with attention-deficit/hyperactivity disorder (ADHD). Studies from the investigator's laboratory and colleagues suggest physical movement can enhance cognitive performance in children with ADHD. Hyper-sensorimotor behavior may be related to impaired regulation of arousal in the noradrenergic and dopaminergic systems. This project will assess if frequency and characteristics of sensorimotor behavior relates to cognitive and emotional response in adults with ADHD, in a fine-grained manner, unlike other studies. The investigators will test if intrinsic fidgeting (Aim 1) and access to a specially designed fidget device (Aim 2) modulates behavioral and physiological response in cognitively and emotionally-demanding contexts. The hype of the commercially available fidget devices, its competitors and fidget spinners suggest it might, but there is no systematic evidence to inform consumers, a gap, the investigators aim to fill.

Eligibility criteria: Inclusion Criteria:

* ADHD
* History of fidgeting

Exclusion Criteria:

* Currently taking psychoactive medication, with the exception of stimulant medication for ADHD or medication that can affect heart rate;
* Presence of significant depression or psychotic disorders, autism, visual or hearing impairment or any other disorder that may interfere with task performance; and IQ below 85

Primary outcomes:
measure: Processing speed
timeFrame: Day 1
measure: Working memory
timeFrame: Day 1
measure: Response inhibition
timeFrame: Day 1
Secondary outcomes:
measure: Physiological response as an index of emotional regulation
timeFrame: Approximately 45 minutes
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis MIND Institute
state: California
Study officials:
affiliation: UC Davis MIND Institute
name: Julie Schweitzer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: