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.
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
- Conditions the study is for
- ADHD - Attention Deficit Disorder With Hyperactivity
- 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
- 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
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:
- 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;
- 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 group | Role | What they receive |
|---|---|---|
| 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) . 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.
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.
- First posted28 Mar 2025
- Study start11 Nov 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD - Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sustained Endogenous Attention Deficits in Attention Deficit Hyperactivity Disorder: Validation of a Computerized Neuropsychological Test."
- ClinicalTrials.gov ID
- NCT06900400
- Acronym / sponsor ID
- 1064
- Keywords
- Case control, diagnostic, ADHD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
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:
- 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;
- 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| ADHD group and Control Group | Other | Diagnostic Test: Sustained-Paced Finger Tapping" (Petilli et al., 2018)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) . |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustained-Paced Finger Tapping" (Petilli et al., 2018)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). | Diagnostic test | ADHD group and Control Group |
Primary outcome
Performances on Sustained-Paced Finger Tapping test
Time frame: baseline
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
2 sites in 1 country: see every site and its status.
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.