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ADHD - Attention Deficit Disorder With HyperactivityNCT06900400

Sustained Endogenous Attention Deficits in Attention Deficit Hyperactivity Disorder

A study testing Sustained-Paced Finger Tapping" (Petilli et al., 2018) in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by IRCCS Eugenio Medea at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 13 yearsHealthy volunteers can take part
What is being tested?
Sustained-Paced Finger Tapping" (Petilli et al., 2018)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesItaly
Study dates
11 Nov 2024to May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 13 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Italy2 sites, 2 recruiting
  • 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

    Luigi Macchitella, 0831349111 ext. +39, luigi.macchitella@lanostrafamiglia.it

    Recruiting
  • Università del Salento

    Lecce

    Paola Angelelli, 0831349111 ext. +39, paola.angelelli@unisalento.it

    Recruiting

Other trials in Italy

About this study

Official title: Evaluation of Sustained Endogenous Attention Deficits in Attention Deficit Hyperactivity Disorder: Validation of a Computerized Neuropsychological Test."

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."

Read the detailed description

Recently, a distinction has been recognized between external sustained attention and internal sustained attention. Internal sustained attention is defined as the ability to maintain attention over time on neurocognitive processes that, rather than processing external information, act on information stored in memory. The "Sustained-Paced Finger Tapping" test was developed and used in experimental research protocols in international literature to assess internal sustained attention in typically developing children. While numerous studies confirm that ADHD is associated with deficits in external sustained attention, the international literature emphasizes that internal attention has been underexplored in ADHD. A pilot study conducted by the University of Salento revealed preliminary data showing that children with ADHD exhibit significantly lower performance compared to control subjects in the "Sustained-Paced Finger Tapping." Despite these preliminary data suggesting that the "Sustained-Paced Finger Tapping" test has the ability to discriminate between children with and without ADHD, there are no published studies formally investigating this hypothesis. Two subject samples will be recruited: one sample of subjects with ADHD and one sample of subjects without ADHD and with typical development. The ADHD diagnosis will be made based on the concordance of four data sources: 1) the detection of diagnostic criteria indicated in the DSM-5 through interviews, medical history, and observation during a neuropsychiatric and psychological visit; 2) high and/or medium-high scores, i.e., ≥ 65/70 T, on the ADHD symptom subscales of both the Conners-3-Parent and the CBCL-Parent; 3) high and/or medium-high scores, i.e., ≥ 65/70 T, on the ADHD symptom subscales of at least one questionnaire (Conners-3 or CBCL) administered to teachers; 4) the presence of all DSM-5 symptoms for ADHD on the Conners-3 scale for both parents and teachers.

Inclusion criteria:

ADHD Group:

Subjects with a diagnosis of ADHD (of any severity level and subtype) aged between 6 and 10 years; "Medication-naive" ADHD subjects, i.e., subjects who have not been prescribed and/or have not yet started taking any medication for ADHD; IQ ≥ 70.

Non-ADHD Group:

Normal IQ; Aged between 6 and 10 years.

Exclusion criteria:

Exclusion criteria for both groups:

Symptoms suggestive of autism spectrum disorders, psychotic disorders, mood disorders, and anxiety disorders; Use of psychotropic drugs; Subjects with cerebral palsy and/or neuromotor and neuromuscular disorders; CNS diseases (e.g., epilepsy and/or neurodegenerative diseases) or CNS injuries due to, for example, head trauma or stroke.

The assessment of autism spectrum disorder symptoms will be carried out using the SRS-2 questionnaire, while the evaluation of other exclusion criteria will be done through medical history and clinical interview during enrollment.

Exclusion criteria for the non-ADHD group:

Presence of ADHD symptoms as identified through clinical interview and administration of a questionnaire (questionnaire from the BIA battery).

Both groups of subjects will be administered the "Sustained-Paced Finger Tapping". 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).

Depending on the variables to be analyzed, non-parametric statistics or the Student's t-test and/or ANOVA will be used. ANCOVA will be employed to assess significant differences between the study variables, accounting for variables that could influence the potential differences (e.g., demographic differences between groups). ROC curve analysis, the Youden Index, and the specific formulas for calculating the diagnostic characteristics of the test will be used. The discriminant validity and the presence of any deficits in the performance related to the test will be evaluated in two ways:

  1. by comparing the performances obtained from subjects with and without ADHD. To this end, the Student's t-test and/or analysis of variance (ANOVA) will be used, and if significant differences are found between the two groups regarding variables other than the dependent variables, ANCOVA will be implemented;
  2. by calculating sensitivity, specificity, accuracy indices, and test cut-offs. These parameters will be calculated using the ADHD diagnosis as the gold standard for the subjects with ADHD.

The cut-off will be calculated through ROC curve analysis and the Youden Index. By "cut-off" of the test, we mean the score that best discriminates, with a certain degree of accuracy, the optimal balance between sensitivity and specificity, separating subjects with ADHD from those without ADHD. In this sense, the cut-off is considered a measure of discriminant validity, similar to statistically significant differences that can be identified using other statistical techniques.

Ecological validity will be assessed by calculating correlations and regressions between the test scores and the scores obtained on the Conners scales. Finally, simple and partial correlations will be calculated between the Sustained-Paced Finger Tapping scores and the scores from other neuropsychological tests and questionnaires administered in order to gather information on various types of validity of the instrument (construct validity, divergent, and convergent validity).

Being tested
Sustained-Paced Finger Tapping" (Petilli et al., 2018)
Keywords
Case control, diagnostic, ADHD
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sustained-Paced Finger Tapping" (Petilli et al., 2018)Diagnostic test

    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).

Study groups in NCT06900400
Study groupRoleWhat they receive
ADHD group and Control GroupOtherThe 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) .
Receives: Diagnostic Test: Sustained-Paced Finger Tapping" (Petilli et al., 2018)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2025
  2. Study start11 Nov 2024
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
The same neuropsychological test is administered to two groups of subjects: one group of subjects with ADHD and one group of typically developing subjects.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06900400
Sponsor's protocol ID
1064
Status last verified
Mar 2025
First submitted
20 Mar 2025
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Sustained-Paced Finger Tapping" (Petilli et al., 2018) in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by IRCCS Eugenio Medea at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performances on Sustained-Paced Finger Tapping test (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.

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