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Recruiting NCT04526600

Fidgeting and Attentional and Emotional Regulation in ADHD

No phase Interventional ADHD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fidget ball.
Who it may be relevant to
Registry conditions: ADHD. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Can Fidgeting Lead to Enhanced Attention and Emotional Regulation in ADHD?

Overview

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.

Interventions

  • Other Fidget ball
    Access to a prototype 'smart' fidget ball with pressure sensors embedded, that produces touch traces and transmits real time data

Primary outcome measures

  • Processing speed [Time frame: Day 1]
  • Working memory [Time frame: Day 1]
  • Response inhibition [Time frame: Day 1]
Secondary outcome measures (1)
  • Physiological response as an index of emotional regulation [Time frame: Approximately 45 minutes]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • UC Davis MIND Institute — Sacramento

Identifiers

NCT: NCT04526600 · 1607722

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗