NCT03564210

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

May 23, 2018

Last Update Submit

November 4, 2020

Conditions

Concussion, Brain

Keywords

screen time

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Number of specific symptoms (Day 1-3)

    Day 1 to day 3

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

    Day 4 to day 10

  • Severity of specific symptoms (Day 1-3)

    Day 1 to day 3

  • Severity of specific symptoms (Day 4-10)

    Day 4 to day 10

  • Amount of screen time use

    Randomization to 48 hours.

  • +1 more secondary outcomes

Study Arms (2)

Screen time permitted

ACTIVE COMPARATOR

Concussion sufferers permitted screen time for first 48 hours of recovery

Behavioral: Screen time permitted

Screen time abstain

ACTIVE COMPARATOR

Concussion sufferers asked to abstain from screen time for first 48 hours of recovery

Behavioral: Screen Time Abstain

Interventions

Screen time permittedBEHAVIORAL

Cohort will not be directed to abstain from screen time

Screen time permitted
Screen Time AbstainBEHAVIORAL

Cohort will be directed to abstain from screen time

Screen time abstain

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

  • 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.

    PMID: 34491285DERIVED

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Theodore Macnow, MD

    UMass Memorial Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of pediatrics

Study Record Dates

First Submitted

May 23, 2018

First Posted

June 20, 2018

Study Start

May 7, 2018

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)