NCT06900400

Brief Summary

Subjects with ADHD may exhibit deficits in sustained internal attention. The "Sustained-Paced Finger Tapping" test was recently developed and experimentally used in international literature to assess sustained internal attention in typically developing children. This clinical study has several objectives: 1) to assess the presence of "internal" sustained attention deficits in children with ADHD through the "Sustained-Paced Finger Tapping"; 2) to evaluate the discriminant and ecological validity of the "Sustained-Paced Finger Tapping."

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

March 20, 2025

Last Update Submit

March 27, 2025

Conditions

Keywords

Case controldiagnosticADHD

Outcome Measures

Primary Outcomes (1)

  • Performances on Sustained-Paced Finger Tapping test

    Both groups of subjects (i.e. ADHD group and Control Group) will be administered the "Sustained-Paced Finger Tapping" (Petilli et al., 2018). It is a computerized test that lasts approximately 10 minutes. It consists of maintaining and reproducing for a certain period of time (10 minutes) the rhythm of a sound presentation (auditory version).

    baseline

Study Arms (1)

ADHD group and Control Group

OTHER

The same neuropsychological test (i.e.Sustained-Paced Finger Tapping) is administered to two groups of subjects: one group of subjects with ADHD and one group of typically developing subjects. Sustained-Paced Finger Tapping" (Petilli et al., 2018) is a computerized test that lasts approximately 10 minutes. It involves maintaining and reproducing the rhythm of a sound (auditory version) .

Diagnostic Test: Sustained-Paced Finger Tapping" (Petilli et al., 2018)

Interventions

Sustained-Paced Finger Tapping" (Petilli et al., 2018) a computerized test that lasts approximately 10 minutes. It involves maintaining and reproducing the rhythm of a sound (auditory version).

ADHD group and Control Group

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ADHD Group (1) Subjects with a diagnosis of ADHD of any severity level and subtype
  • ADHD Group (2) "Medication-naive" ADHD subjects, meaning subjects who have not been prescribed and/or have not yet started any pharmacological treatment for ADHD
  • ADHD Group (3) IQ ≥ 70
  • Non-ADHD Group, Normal IQ

You may not qualify if:

  • for both groups, symptomatology suggestive of autism spectrum disorders, psychotic disorders, mood disorders, and anxiety disorders
  • for both groups, use of psychotropic drugs
  • for both groups, subjects with cerebral palsy and/or neuromotor and neuromuscular disorders
  • for both groups, CNS diseases, e.g., epilepsy and/or neurodegenerative diseases, or central nervous system injuries resulting from, for example, head trauma or stroke
  • for the non-ADHD group, presence of ADHD symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Associazione "La Nostra Famiglia"-IRCCS "E. Medea"-Scientific Hospital for Neurorehabilitation-Unit for Severe Disabilities in Developmental Age and Young Adults (Developmental Neurology and Neurorehabilitation)

Brindisi, Italy

RECRUITING

Università del Salento

Lecce, Italy

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityDisease

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: The same neuropsychological test is administered to two groups of subjects: one group of subjects with ADHD and one group of typically developing subjects.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2025

First Posted

March 28, 2025

Study Start

November 11, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations