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Fidgeting and Attentional and Emotional Regulation in ADHD

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ClinicalTrials.gov Identifier: NCT04526600
Recruitment Status : Recruiting
First Posted : August 26, 2020
Last Update Posted : June 7, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
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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.

Condition or disease Intervention/treatment Phase
ADHD Other: Fidget ball Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Can Fidgeting Lead to Enhanced Attention and Emotional Regulation in ADHD?
Actual Study Start Date : March 21, 2022
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2024
Arms and Interventions
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Arm Intervention/treatment
No Intervention: No fidget
Experimental: With fidget
The participant is given a specially designed fidget ball
 Other: Fidget ball
Access to a prototype 'smart' fidget ball with pressure sensors embedded, that produces touch traces and transmits real time data


Outcome Measures
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Primary Outcome Measures :
  1. Processing speed [ Time Frame: Day 1 ]
    Paced Auditory Serial Addition Task (PASAT)

  2. Working memory [ Time Frame: Day 1 ]
    List Sorting Test

  3. Response inhibition [ Time Frame: Day 1 ]
    Flanker type test


Secondary Outcome Measures :
  1. Physiological response as an index of emotional regulation [ Time Frame: Approximately 45 minutes ]
    Heart rate variability and pre ejection period


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526600


Contacts
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Contact: Jared Borden 916-703-0294 jborden@ucdavis.edu

Locations
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United States, California
UC Davis MIND Institute Recruiting
Sacramento, California, United States, 95817
Contact: Jared Borden    916-703-0294    jborden@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Julie Schweitzer, Ph.D. UC Davis MIND Institute
More Information
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Additional Information:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04526600    
Other Study ID Numbers: 1607722
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared via NDAR
Supporting Materials: Study Protocol
Time Frame: Undecided, likely after publication date
Access Criteria: Will be through NDAR

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No