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The Effect of Screen Time on Recovery From Concussion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03564210
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Theodore Macnow, University of Massachusetts, Worcester

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).

Condition or disease Intervention/treatment Phase
Concussion, Brain Behavioral: Screen time permitted Behavioral: Screen Time Abstain Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Screen Time on Recovery From Concussion
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Active Comparator: Screen time permitted
Concussion sufferers permitted screen time for first 48 hours of recovery
Behavioral: Screen time permitted
Cohort will not be directed to abstain from screen time

Active Comparator: Screen time abstain
Concussion sufferers asked to abstain from screen time for first 48 hours of recovery
Behavioral: Screen Time Abstain
Cohort will be directed to abstain from screen time




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564210


Contacts
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Contact: Theodore Macnow, MD 610-613-0533 theodore.macnow@umassmemorial.org

Locations
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United States, Massachusetts
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Principal Investigator         
Principal Investigator: Theodore E Macnow, md         
Sponsors and Collaborators
Theodore Macnow
Investigators
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Principal Investigator: Theodore Macnow, MD UMass Memorial Medical Center
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Responsible Party: Theodore Macnow, Assistant professor of pediatrics, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03564210    
Other Study ID Numbers: H00014355
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Theodore Macnow, University of Massachusetts, Worcester:
screen time
Additional relevant MeSH terms:
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Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating