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Clinical Trial 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. Patients´visit 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder With Hyperactivity
  • Hyperkinesis

NCT number NCT04355065
Study type Interventional
Source Puerta de Hierro University Hospital
Contact Hilario M Blasco-Fontecilla, ID
Phone +34 655214857
Email hmblasco@yahoo.es
Status Recruiting
Phase Phase 2
Start date December 9, 2019
Completion date January 22, 2021

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