ADHD, Deficits in Motor Control and PerceptionNCT06477575
Effectiveness of Technology-based Interventions for the Improvement of Cognitive Processes in ADHD.
A study testing neurocognitive therapy based on new technologies and conventional neurocognitive therapy in people with ADHD, Deficits in Motor Control and Perception, run by University of Extremadura at 1 site in Spain.
Trial summary
To scientifically demonstrate the improvements in cognitive functions and core symptoms of children and adolescents diagnosed with ADHD through the implementation of a cognitive rehabilitation program based on the use of the most relevant technologies found in the systematic review carried out during the first phase. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ADHD, Deficits in Motor Control and Perception
- What is being tested?
- neurocognitive therapy based on new technologies and conventional neurocognitive therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents diagnosed with ADHD
- Age: 6-17 years old
Who cannot join
- Children and adolescents diagnosed with ADHD + ADD.
- Age: under 6 years old or over 17 years old.
- Other psychopharmacological treatments not specific for ADHD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Technology-based Interventions for the Improvement of Cognitive Processes in Children and Adolescents With ADHD.
To scientifically demonstrate the improvements in cognitive functions and core symptoms of children and adolescents diagnosed with ADHD through the implementation of a cognitive rehabilitation program based on the use of the most relevant technologies found in the systematic review carried out during the first phase.
Two intervention groups will be randomly assigned for the study:
G1: composed of 20 patients who will receive neurocognitive therapy based on new technologies. This will be the experimental group.
G2: composed of 20 patients who will receive conventional neurocognitive therapy for ADHD treatment. This group will be the control group
- Being tested
- neurocognitive therapy based on new technologies, conventional neurocognitive therapy
- Keywords
- ADHD, cognitive rehabilitation, new technologies
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurocognitive therapy based on new technologiesDevice
The cognitive neurorehabilitation program is based on gaming through the use of the Nintendo Switch device. The following games have been chosen: Pufferfish, Hex Egg, Mystic Totem, Thor's Thunder, since they are games that work on selective attention, concentration and processing speed, which are the variables to be studied in this project.
Hardware: Nintendo Switch Software: 60 in 1 game Games: Pufferfish, Hex Egg, Mystic Totem, Thor's Thunder. Therapy time: 30 minutes effective. Number of Sessions: 2 per week / Number of weeks: 8 Total number of intervention sessions: 16 sessions Place: Thercli Center (Don Benito).
conventional neurocognitive therapyOther
The cognitive neurorehabilitation program for group active comparator is based on playing more conventional board games that work on selective attention, concentration and processing speed, which are the variables to be studied in this project.
Traditional games and token book. Games: Dobble, Lynx, Crazy cups, Jungle speed, animalea, ghost. Card: Stimulate and learn level 3 and 4. Therapy time: 30 minutes effective. No. of sessions: 2 per week / No. of weeks: 8 Total number of intervention sessions: 16 sessions Place: Thercli Center (Don Benito).
| Study group | Role | What they receive |
|---|---|---|
| neurocognitive therapy based on new technologies | Experimental | Not described Receives: Device: neurocognitive therapy based on new technologies |
| conventional neurocognitive therapy | Active comparator | Not described Receives: Other: conventional neurocognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
WisC-V (Wechsler intelligence scale for children)
provides primary intelligence index scores that reflect intellectual functioning in different cognitive areas: verbal comprehension, visuospatial, fluid reasoning, working memory and processing speed.
Measured: 8 weeks
STROOP (Colors and Words Test)
reference test for the detection of neuropsychological problems and brain damage. It allows to evaluate the phenomenon of interference, intimately linked to inhibitory control processes.
Measured: 8 weeks
CARAS-R(Difference perception test)
evaluates the ability to quickly and correctly perceive similarities and differences in partially ordered patterns of stimulation. It measures perceptual and attentional skills by means of 60 graphic items consisting of schematic drawings of faces with elementary strokes.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Mar 2024
- Primary completion20 Mar 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD, Deficits in Motor Control and PerceptionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Caña Pino, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477575
- Sponsor's protocol ID
- 210624
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Technology-based Interventions for the Improvement of Cognitive Processes in Children and Adolescents With ADHD.
- ClinicalTrials.gov ID
- NCT06477575
- Acronym / sponsor ID
- 210624
- Keywords
- ADHD, cognitive rehabilitation, new technologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 27 Jun 2024 (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.
To scientifically demonstrate the improvements in cognitive functions and core symptoms of children and adolescents diagnosed with ADHD through the implementation of a cognitive rehabilitation program based on the use of the most relevant technologies found in the systematic review carried out during the first phase.
Two intervention groups will be randomly assigned for the study:
G1: composed of 20 patients who will receive neurocognitive therapy based on new technologies. This will be the experimental group.
G2: composed of 20 patients who will receive conventional neurocognitive therapy for ADHD treatment. This group will be the control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neurocognitive therapy based on new technologies | Experimental | Device: neurocognitive therapy based on new technologies |
| conventional neurocognitive therapy | Active comparator | Other: conventional neurocognitive therapy |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children and adolescents diagnosed with ADHD
- Age: 6-17 years old
Key exclusion criteria (3 listed)
- Children and adolescents diagnosed with ADHD + ADD.
- Age: under 6 years old or over 17 years old.
- Other psychopharmacological treatments not specific for ADHD.
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 |
|---|---|---|
| neurocognitive therapy based on new technologiesThe cognitive neurorehabilitation program is based on gaming through the use of the Nintendo Switch device. The following games have been chosen: Pufferfish, Hex Egg, Mystic Totem, Thor's Thunder, since they are games that work on selective attention, concentration and processing speed, which are the variables to be studied in this project. Hardware: Nintendo Switch Software: 60 in 1 game Games: Pufferfish, Hex Egg, Mystic Totem, Thor's Thunder. Therapy time: 30 minutes effective. Number of Sessions: 2 per week / Number of weeks: 8 Total number of intervention sessions: 16 sessions Place: Thercli Center (Don Benito). | Device | neurocognitive therapy based on new technologies |
| conventional neurocognitive therapyThe cognitive neurorehabilitation program for group active comparator is based on playing more conventional board games that work on selective attention, concentration and processing speed, which are the variables to be studied in this project. Traditional games and token book. Games: Dobble, Lynx, Crazy cups, Jungle speed, animalea, ghost. Card: Stimulate and learn level 3 and 4. Therapy time: 30 minutes effective. No. of sessions: 2 per week / No. of weeks: 8 Total number of intervention sessions: 16 sessions Place: Thercli Center (Don Benito). | Other | conventional neurocognitive therapy |
Primary outcome
WisC-V (Wechsler intelligence scale for children)
Time frame: 8 weeks
provides primary intelligence index scores that reflect intellectual functioning in different cognitive areas: verbal comprehension, visuospatial, fluid reasoning, working memory and processing speed.
STROOP (Colors and Words Test)
Time frame: 8 weeks
reference test for the detection of neuropsychological problems and brain damage. It allows to evaluate the phenomenon of interference, intimately linked to inhibitory control processes.
CARAS-R(Difference perception test)
Time frame: 8 weeks
evaluates the ability to quickly and correctly perceive similarities and differences in partially ordered patterns of stimulation. It measures perceptual and attentional skills by means of 60 graphic items consisting of schematic drawings of faces with elementary strokes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurocognitive therapy based on new technologies and conventional neurocognitive therapy in people with ADHD, Deficits in Motor Control and Perception, run by University of Extremadura at 1 site in Spain.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WisC-V (Wechsler intelligence scale for children) (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 27 Jun 2024.