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Completed

NCT Number: NCT03564210

The Effect of Screen Time on Recovery From Concussion

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).

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Key information

Conditions

Concussion, Brain Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Screen time permitted

Behavioral

Cohort will not be directed to abstain from screen time

Screen Time Abstain

Behavioral

Cohort will be directed to abstain from screen time

Primary outcomes

  1. Duration of concussive symptoms

    Time frame: From date of randomization until PCSS of less than 7 is achieved or up to 10 days, whichever comes first.

    The average number of days from initial concussion diagnosis until participant has a Post Concussive Symptom Scale Score (PCSS) of less than 7

Secondary outcomes

  1. Number of specific symptoms (Day 1-3)

    Time frame: Day 1 to day 3

    The average total number of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant.

  2. Number of specific symptoms each day (Day 4-10)

    Time frame: Day 4 to day 10

    The average total number of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant.

  3. Severity of specific symptoms (Day 1-3)

    Time frame: Day 1 to day 3

    The average severity of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant.

  4. Severity of specific symptoms (Day 4-10)

    Time frame: Day 4 to day 10

    The average severity of symptoms as reported daily by participant on the Post Concussive Symptom Scale (PCSS) by participant.

  5. Amount of screen time use

    Time frame: Randomization to 48 hours.

    Average minutes of screen time (video games, television, computer, smartphone) as self-reported by participant on questionnaire.

  6. Days until return to school/work and sports

    Time frame: From date of randomization to return to school/work and sports, up to day 10.

    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.

Sponsors and collaborators

Lead sponsor

Theodore Macnow

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 20, 2018
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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