Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05067322 |
| Other study ID # |
TVG001 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 9, 2017 |
| Est. completion date |
September 23, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Spherix Incorporated |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Children with ADHD play a videogame to test symptom control
Description:
Minecraft is an online video game containing a "virtual land where users can create their own
worlds and experiences, using building blocks, resources discovered on the site and their own
creativity" that requires its users to apply problem solving, planning, and organizational
skills for creative building and exploration.1
It is being studied as an adjunctive treatment in combination with stimulant medications in
children with attention deficit hyperactivity disorder (ADHD) to improve executive function
and ADHD symptoms, as well as to allow for the use of lower doses of stimulant drugs.
Although there is little research on the effect of Minecraft in humans, there is considerable
research on the effects of other video games. Like pharmaceuticals, the effect seen seems to
be often related to the amount and style of video games to which humans are exposed.
First-person shooter games with violence have been associated with anxiety and fear
(Strasburger et al. 2010). The negative outcomes of video play include obesity,
aggressiveness, antisocial behavior, and addiction (Strasburger et al 2010).2 Video and
computer games come in many different genres, some violent, some nonviolent, some with lots
of action, some without any action, etc. Chess and checkers were among the earliest computer
games and they still remain popular. Cognitive training interventions administered in a game
format have been studied in children with ADHD. Taken together, the results of studies show
that these cognitive training interventions are generally effective in improving the specific
executive functions they target, as well as parent-reported ADHD symptoms. The majority of
the interventions studied have targeted training of working memory, although some
interventions have also targeted attention, response inhibition, and cognitive flexibility in
the training. A recent meta-analysis found that interventions targeting multiple executive
function domains had a stronger effect on parent-reported ADHD symptoms than studies
targeting working memory alone (which showed minimal benefits), but it is possible that the
greater benefits seen were due to a more intensive intervention schedule.3
The improvements in cognitive assessments and parent-rated ADHD symptoms have been shown to
persist for up to 6 months after completion of training.4 However, it should be noted that
the improvements in cognitive function could be due to practice effects arising from
repetition of the cognitive tasks, rather than a true alteration in cognitive function.5 In
contrast to the effects on "near-transfer" functions and parent-rated ADHD symptoms, evidence
of "far-transfer" effects to untrained functions and non-clinical environments has been
limited, and improvements in teacher-rated ADHD symptoms have not been observed. The latter
observation is particularly important as teacher ratings of ADHD symptoms can be a more
objective measure of efficacy than parent ratings, and the most significant limitations for a
majority of the studies have been effective blinding procedures and an appropriate control
condition. These results are further limited by overrepresentation of males subjects in study
populations, the exclusion of patients with comorbidities in most of the studies, and small
sample sizes (for review, see Rutledge, et al. (2012), Chacko, et al. (2013) , and Rivero, et
al. (2015)).
