Ignite Creation Date:
2024-05-06 @ 2:34 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04355065
Status:
UNKNOWN
Last Update Posted:
2020-04-21
First Post:
2020-04-17
Brief Title:
The Secret Trail of Moon Serious Videogame and Chess on ADHD a Clinal Trial
Sponsor:
Puerta de Hierro University Hospital
Organization:
Puerta de Hierro University Hospital
Study Overview
Official Title:
Randomized Study of Personalized Cognitive Training With Virtual Reality Technology The Secret Trail of Moon Versus Online Therapeutic Chess Cognitive Training Versus Usual Treatment TAU in Attention Deficit Hyperactivity Disorder ADHDa Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Blackground
Currently research on alternative forms of cognitive training in patients diagnosed with ADHD is gaining interest Especially the use of Virtual Reality video games Our team has developed an innovative video game based on Virtual Reality The Secret Trail of Moon TSTM as a cognitive tool to train 5 main areas of deficit in patients with ADHD It is superiority study comparing TSTM with therapeutic chess and control group
Methods
This study is prospective unicentric randomized with a control group 105 patients diagnosed with ADHD and pharmacologically stable aged between 12 and 22 years These patients will be randomized intro three groups TSTM group The Secret Trail of Moon TC group Therapeutic Chess and CG Control Group Objective and subjective measures of the patient parents and teachers will be included Patientsvisit will be different for each group The TSTM group will have 15 face-to face visits pre-inclusion visit inclusion visit 12 training visits and final visit CT and GC group patients will have 3 face-to- face visits pre-inclusion initial visit and final visit and 12 email or phone communications during training
Discussion This study aims to demonstrate the added efficacy of cognitive training to drug treatment It is a study that tries to demonstrate the superiority of cognitive training with TSTM compared to a traditional cognitive training TC and a control group
TSTM is presented as a new and powerful cognitive tool thanks to four factors that make it unique the feeling of immersion in the scenarios the variety of mechanics the personalization and the playful aspect
Currently research on alternative forms of cognitive training in patients diagnosed with ADHD is gaining interest Especially the use of Virtual Reality video games Our team has developed an innovative video game based on Virtual Reality The Secret Trail of Moon TSTM as a cognitive tool to train 5 main areas of deficit in patients with ADHD It is superiority study comparing TSTM with therapeutic chess and control group
Methods
This study is prospective unicentric randomized with a control group 105 patients diagnosed with ADHD and pharmacologically stable aged between 12 and 22 years These patients will be randomized intro three groups TSTM group The Secret Trail of Moon TC group Therapeutic Chess and CG Control Group Objective and subjective measures of the patient parents and teachers will be included Patientsvisit will be different for each group The TSTM group will have 15 face-to face visits pre-inclusion visit inclusion visit 12 training visits and final visit CT and GC group patients will have 3 face-to- face visits pre-inclusion initial visit and final visit and 12 email or phone communications during training
Discussion This study aims to demonstrate the added efficacy of cognitive training to drug treatment It is a study that tries to demonstrate the superiority of cognitive training with TSTM compared to a traditional cognitive training TC and a control group
TSTM is presented as a new and powerful cognitive tool thanks to four factors that make it unique the feeling of immersion in the scenarios the variety of mechanics the personalization and the playful aspect
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None