Fidgeting and Attentional and Emotional Regulation in ADHD

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04526600
• Other study ID #: 1607722
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2023
• Source: University of California, Davis
• Contact: Jared Borden
• Phone: 916-703-0294
• Email: jborden[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 109
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

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

Locations

Country	Name	City	State
United States	UC Davis MIND Institute	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Processing speed	Paced Auditory Serial Addition Task (PASAT)	Day 1
Primary	Working memory	List Sorting Test	Day 1
Primary	Response inhibition	Flanker type test	Day 1
Secondary	Physiological response as an index of emotional regulation	Heart rate variability and pre ejection period	Approximately 45 minutes

External Links

•   Learn more or sign up for the study here!