Clinical trial NCT03564210: The Effect of Screen Time on Recovery From Concussion
Official title: The Effect of Screen Time on Recovery From Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Brain
Keywords: screen time
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 125
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will prospectively examine the effect of screen time on recovery from concussion. Patients 12 to 25 years of age presenting to the ED with a concussion will be randomized to allow for screen time as tolerated or to abstain from screen time for the first 48 hours of recovery. The amount of screen time use and duration of concussive symptoms will be assessed through daily surveys and a daily post-concussive symptom score (PCSS).


Eligibility criteria: Inclusion Criteria:

* Individuals presenting to the emergency department with a traumatic head injury sustained in the last 24 hours and diagnosed concussion as defined by Acute Concussion Evaluation tool (ACE-ED)
* Between 12 and 25.99 years of age
* English-speaking
* Subject (and parent/guardian when applicable) is able and willing to provide informed consent and assent
* pregnant women,

Exclusion Criteria:

* individuals who have a Glasgow Coma Scale score of 13 or less;
* have brain abnormalities on imaging;
* have severe preexisting neurological conditions;
* a concussion diagnosed within the last 2 weeks;
* have significant developmental delay;
* are intoxicated;
* require neurosurgical intervention, intubation, or hospital admission
* individuals who do not meet the age criteria;
* non-English speaking;
* prisoners;
* unable or unwilling to provide informed consent;
* Are under the age of 18 and do not have a parent/guardian with them who is willing and able to consent.

Primary outcomes:
measure: Duration of concussive symptoms
timeFrame: From date of randomization until PCSS of less than 7 is achieved or up to 10 days, whichever comes first.
Secondary outcomes:
measure: Number of specific symptoms (Day 1-3)
timeFrame: Day 1 to day 3
measure: Number of specific symptoms each day (Day 4-10)
timeFrame: Day 4 to day 10
measure: Severity of specific symptoms (Day 1-3)
timeFrame: Day 1 to day 3
measure: Severity of specific symptoms (Day 4-10)
timeFrame: Day 4 to day 10
measure: Amount of screen time use
timeFrame: Randomization to 48 hours.
measure: Days until return to school/work and sports
timeFrame: From date of randomization to return to school/work and sports, up to day 10.
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMass Memorial Health
name: Theodore Macnow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Macnow T, Curran T, Tolliday C, Martin K, McCarthy M, Ayturk D, Babu KM, Mannix R. Effect of Screen Time on Recovery From Concussion: A Randomized Clinical Trial. JAMA Pediatr. 2021 Nov 1;175(11):1124-1131. doi: 10.1001/jamapediatrics.2021.2782.