NCT04526600

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Mar 2022Jun 2026

First Submitted

Initial submission to the registry

August 11, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2.3 years

First QC Date

August 11, 2020

Last Update Submit

February 9, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Processing speed

    Paced Auditory Serial Addition Task (PASAT)

    Day 1

  • Working memory

    List Sorting Test

    Day 1

  • Response inhibition

    Flanker type test

    Day 1

Secondary Outcomes (1)

  • Physiological response as an index of emotional regulation

    Approximately 45 minutes

Study Arms (2)

No fidget

NO INTERVENTION

With fidget

EXPERIMENTAL

The participant is given a specially designed fidget ball

Other: Fidget ball

Interventions

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

With fidget

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ADHD
  • History of fidgeting

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis MIND Institute

Sacramento, California, 95817, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Julie Schweitzer, Ph.D.

    UC Davis MIND Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 26, 2020

Study Start

March 21, 2022

Primary Completion

July 1, 2024

Study Completion (Estimated)

June 1, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Data will be shared via NDAR

Shared Documents
STUDY PROTOCOL
Time Frame
Undecided, likely after publication date
Access Criteria
Will be through NDAR

Locations