Rozwój interwencji opartych na wirtualnej rzeczywistości w celu wzmocnienia umiejętności poznawczych związanych z zespołem nadpobudliwości psychoruchowej z deficytem uwagi (ADHD)
Opracowanie interwencji opartych na rzeczywistości wirtualnej w celu wzmocnienia umiejętności poznawczych związanych z zespołem nadpobudliwości psychoruchowej z deficytem uwagi (ADHD): randomizowane, kontrolowane badanie fazy II
Background:
Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems. It may be hard for them to control their behaviors, concentrate for long periods, or make decisions. This can affect their education, friendships, and daily life. Virtual reality-based games may help improve cognitive skills in children with ADHD. It may also help change how the brain functions.
Objective:
To see if virtual reality-based games help improve thinking skills and brain function in children with ADHD.
Eligibility:
Children aged 8 to 16 years with ADHD.
Design:
We will first do a pilot study, meaning that everyone will receive the games. If this is successful, we will then conduct a randomized controlled trial, meaning that some participants will be randomly assigned to the full version of the games and some will be randomly assigned to a limited version. Participants will be screened. Their physical and mental health, medical and family history, and intellectual and emotional development will be evaluated. They will have tests of their mood, memory, attention, thinking, and behavior. Participants may have an MRI scan of the brain. They may also have magnetoencephalography (MEG) and electroencephalography (EEG) scans, which record brain activity using sensors placed near or on the head. These scans are optional.
Participants will receive a set of virtual reality games. The set includes 3 different games all played using a virtual reality headset. The participant will play the games for 20 minutes 5 days a week for 4 weeks.
The parent or caregiver will start each game using an iPad. Each of the games is designed to help the participant practice specific cognitive skills. These include inhibition control, processing speed, and working memory.
Participants will have interviews each week. They will answer questions about motion sickness, eye strain, headache, and any other side effects, as well as number of game sessions played.
The brain scans may be repeated after the last game session. For the pilot, participants will have a final interview at the study end. For the full trial, a 1-month follow-up visit will be done by telehealth.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Study Description:
This study will be a randomized, double-blind, placebo-controlled trial examining the efficacy of a novel virtual reality (VR) adaptive cognitive training intervention for youth with ADHD in improving symptoms of inattention relative to a non-adaptive training control intervention. Prior to the main randomized trial, a 'proof-of concept' open-label pilot study will assess the safety, tolerability, usability, feasibility, credibility and treatment expectancy of the intervention. It will also provide an initial assessment of the efficacy on the intervention in improving inattention symptoms and neuropsychological performance. When these parameters are met, the pilot will be complete and the RCT will begin.
Objectives:
Primary Objective: Examine the efficacy of the Floreo VR intervention in improving symptoms of inattention in children/adolescents with ADHD.
Secondary Objectives: Examine the efficacy of the VR intervention in improving neuropsychological performance in three cognitive domains pertinent to ADHD.
Pilot Study Objective: Assess the safety, tolerability, usability, feasibility, credibility, and treatment expectancy of the VR intervention. Provide an initial open-label assessment of the efficacy of the intervention.
Endpoints:
Primary Endpoint: The primary endpoint of the main trial is to investigate whether the intervention decreases symptoms of inattention as assessed using the ADHD Rating Scale-5 for Children and Adolescents (ADHD-RS-5).
A secondary aim of the main study is to investigate whether the intervention brings about improvements in performance on three neuropsychological performance indices. These are stop signal reaction time on the Stop Signal task (inhibitory control), visuospatial working memory as determined using number of correct responses on the Dot Matrix task, and the number of correct responses on the NIH Toolbox Pattern Comparison Processing Speed Test. A fourth index, a composite measure of temporal deviation on a Temporal Reproduction task, was included in the Phase I pilot only.
Pilot intervention Endpoints: Responses to structured interview items on safety, tolerability, usability, credibility and treatment expectancy of the intervention. Reports of adverse events will be used to assess safety. Feasibility will be assessed using participation and compliance rates. Usability will also be assessed using a System Usability Scale. Open-label assessments of efficacy will also be performed using the ADHD-RS-5 inattention subscale. Secondary endpoints for the pilot study are the same as for the main study.
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Daniel S Pine, M.D.
- Numer telefonu: (301) 594-1318
- E-mail: daniel.pine@nih.gov
Kopia zapasowa kontaktu do badania
- Nazwa: Saadia A Choudhury
- Numer telefonu: (301) 437-0489
- E-mail: saadia.choudhury@nih.gov
Lokalizacje studiów
-
-
Maryland
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Bethesda, Maryland, Stany Zjednoczone, 20892
- Rekrutacyjny
- National Institutes of Health Clinical Center
-
Kontakt:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Numer telefonu: TTY dial 711 800-411-1222
- E-mail: ccopr@nih.gov
-
Kontakt:
- Saadia Choudhury
- Numer telefonu: (301) 437-0489
- E-mail: saadia.choudhury@nih.gov
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
- INCLUSION CRITERIA:
In order to be eligible to participate, an individual must meet all of the following criteria:
- Children must provide informed assent and parents must provide informed consent to participate in the study.
- Any sex assigned at birth, or race/ethnicity.
- Aged between 8 and 16 years of age, including all months leading up to age 17. For the pilot only, the minimum age was 10 years (i.e., pilot participants were aged 10 to 16 years, including all months leading up to age 17).
- Meets diagnosis for ADHD, predominately inattentive or combined presentations, or a specified presentation of having prominent symptoms of inattention that are impairing in two or more settings (but not numerous enough to meet a diagnosis of inattentive or combined presentation).
- A score of >12 on the ADHD-RS-5 inattention subscale at the screening/baseline assessment. For participants receiving ADHD medication at the time of assessment, the rating will reflect current (i.e., on-medication) symptom levels.
- Stated willingness to comply with all study procedures and lifestyle considerations, availability for the duration of the study, and ability to travel to the NIH Clinical Center for the scheduled in-person study visits.
- For the Pilot only: If treated for ADHD with psychostimulants, willing to withdraw medication three days prior to baseline assessments and to stay off medication until completion of the post-intervention assessment. Not receiving any other psychotropic medication for at least 30 days prior to baseline assessment.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Cognitively not capable of performing study procedures. Indications of a lack of cognitive capacity could include a known IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)
- History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders.
- Impairments in uncorrected visual acuity that would interfere with engagement with the VR training.
- Known to be pregnant.
- Psychotic disorders (including schizophrenia, psychosis not otherwise specified), current substance dependence. Other psychiatric disorders elicited on the interview are not considered exclusionary provided that ADHD is considered to be one of the dominant sources of impairment for the child.
- Considered a suicide risk as determined during the clinical interview at baseline.
- Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments (e.g., limitations in mobility that would render the VR headset unusable).
- Recent (within three months) treatment with other cognitive training interventions (e.g., Cogmed) for ADHD.
- The VR equipment produces excessive discomfort to the child in the opinion of the PI (e.g., including participants with small interpupillary distances (IPD) that are only able to see blurry images on the VR headset, or children showing signs of undue neck and upper body strain or fatigue while trying the headset).
- For the main trial only: Certain psychotropic medications classes that are likely to interfere with the completion of the intervention are exclusionary: antipsychotics, mood stabilizers (lithium, valproate, lamotrigine, gabapentin). In addition, regular use of any other psychoactive (non-stimulant) medication that, in the opinion of the Investigator, may confound study data or interfere with completion of the intervention is exclusionary. Medications for ADHD will not be considered as exclusionary. This includes psychostimulants, atomoxetine, alpha 2 adrenergic agonists. Antidepressant and anxiolytic medication will also not be exclusionary if they are deemed not to interfere with study procedures
- For the main trial only: Prior use of Floreo's products including but not limited to their ADHD cognitive training application.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Floreo VR group
This group will undergo 20 sessions (about 20 minutes each, no more than one per day) of the adaptive Floreo VR training over four weeks, extendable to six weeks to make up missed sessions. Phase I pilot participants also received this intervention in an open-label design. |
Floreo VR is a novel VR-based cognitive training therapy for ADHD. It incorporates multiple learning modules, each of which targets a neuropsychological domain relevant to ADHD (inhibitory control, working memory, and processing speed). A fourth module targeting temporal processing was used in the Phase I pilot only and is not included in the Phase II trial. The demands of the training intervention adapt to the subject's practice-driven improvements in performance. Specifically, when the subject is deemed to perform adequately well at a given level of difficulty, the training adapts by presenting a more challenging difficulty. This adaptation to the subject's performance is designed to allow for continued incremental improvements in the trained domains. The VR games take place in a spaceship themed environment. The VR training is designed to be used at home, under the supervision of a parent. |
|
Pozorny komparator: Non-adaptive VR control group
This group will undergo 20 sessions (about 20 minutes each, no more than one per day) of the non-adaptive Floreo VR control training over four weeks, extendable to six weeks to make up missed sessions. |
The control intervention uses the same Floreo VR training modules, session schedule, headset, and spaceship themed environment as the active intervention. The only difference is that module difficulty is capped at a low level and does not continue to adapt to the child's performance, so demands remain low throughout training. The control training is also completed at home under the supervision of a parent or caregiver, and the two versions are otherwise indistinguishable to families and study staff. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
ADHD-RS-5 inattention sub-scale.
Ramy czasowe: within one month of the end of VR training
|
The ADHD-RS-5 is a rating scale based on the diagnostic criteria for ADHD as described in the DSM-5. Inattention symptoms are one of two key symptom domains for ADHD, and the target of the present intervention. |
within one month of the end of VR training
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Stop signal reaction time on the Stop Signal task (inhibitory control)
Ramy czasowe: within one month of the end of VR training
|
Computerized neuropsychological assessment of inhibitory control |
within one month of the end of VR training
|
|
Temporal deviation on a temporal reproduction task
Ramy czasowe: within one month of the end of VR training
|
Computerized neuropsychological assessment of motor-timing. This measure was collected in the Phase I pilot only and is not administered in the Phase II randomized trial. |
within one month of the end of VR training
|
|
Number of correct responses on the Dot Matrix task
Ramy czasowe: within one month of the end of VR training
|
Computerized neuropsychological assessment of working memory |
within one month of the end of VR training
|
|
Number of correct responses on the NIH Toolbox Pattern Comparison Processing Speed Test.
Ramy czasowe: within one month of the end of VR training
|
Computerized neuropsychological assessment of processing speed |
within one month of the end of VR training
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Daniel S Pine, M.D., National Institute of Mental Health (NIMH)
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 10000744
- 000744-M
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
De-identified data will be placed in NIH-designated repositories in accordance with NIH and NIMH policies and are expected to be submitted to the NIMH Data Archive (NDA). De-identified neuroimaging data may also be deposited in openly accessible repositories such as OpenNeuro. Genomic data, which were collected in the Phase I pilot only, will be shared in controlled-access databases such as dbGaP in accordance with the NIH Genomic Data Sharing Policy. Other databases may be used as approved by NIH for the sharing of de-identified data.
Ramy czasowe udostępniania IPD
The timeline for data sharing will follow NIMH data sharing policies. Currently data is deposited following IRB review once the study data collection is complete and the data has undergone quality control steps.
Kryteria dostępu do udostępniania IPD
Access requests for specific research purposes using NIH controlled-access data are reviewed by NIH Data Access Committees (DACs).
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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