The Effect of Screen Time on Recovery From Concussion

Concussion, Brain Clinical Trial

Official title:

The Effect of Screen Time on Recovery From Concussion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564210
• Other study ID #: H00014355
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: November 2020
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

Intervention

Behavioral:
• Screen time permitted
Cohort will not be directed to abstain from screen time
• Screen Time Abstain
Cohort will be directed to abstain from screen time

Locations

Country	Name	City	State
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Theodore Macnow

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of concussive symptoms	The average number of days from initial concussion diagnosis until participant has a Post Concussive Symptom Scale Score (PCSS) of less than 7	From date of randomization until PCSS of less than 7 is achieved or up to 10 days, whichever comes first.
Secondary	Number of specific symptoms (Day 1-3)	The average total number of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant.	Day 1 to day 3
Secondary	Number of specific symptoms each day (Day 4-10)	The average total number of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant.	Day 4 to day 10
Secondary	Severity of specific symptoms (Day 1-3)	The average severity of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant.	Day 1 to day 3
Secondary	Severity of specific symptoms (Day 4-10)	The average severity of symptoms as reported daily by participant on the Post Concussive Symptom Scale (PCSS) by participant.	Day 4 to day 10
Secondary	Amount of screen time use	Average minutes of screen time (video games, television, computer, smartphone) as self-reported by participant on questionnaire.	Randomization to 48 hours.
Secondary	Days until return to school/work and sports	The average number of days until the participant is able to return to routine activities such as school/work and sports as self-reported on questionnaire.	From date of randomization to return to school/work and sports, up to day 10.