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The Effect of Screen Time on Recovery From Concussion

Primary Purpose

Concussion, Brain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screen time permitted
Screen Time Abstain
Sponsored by
Theodore Macnow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion, Brain focused on measuring screen time

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UMass Memorial Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Screen time permitted

Screen time abstain

Arm Description

Concussion sufferers permitted screen time for first 48 hours of recovery

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of specific symptoms (Day 1-3)
The average total number of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant.
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.
Severity of specific symptoms (Day 1-3)
The average severity of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant.
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.
Amount of screen time use
Average minutes of screen time (video games, television, computer, smartphone) as self-reported by participant on questionnaire.
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.

Full Information

First Posted
May 23, 2018
Last Updated
November 4, 2020
Sponsor
Theodore Macnow
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1. Study Identification

Unique Protocol Identification Number
NCT03564210
Brief Title
The Effect of Screen Time on Recovery From Concussion
Official Title
The Effect of Screen Time on Recovery From Concussion
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Theodore Macnow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain
Keywords
screen time

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screen time permitted
Arm Type
Active Comparator
Arm Description
Concussion sufferers permitted screen time for first 48 hours of recovery
Arm Title
Screen time abstain
Arm Type
Active Comparator
Arm Description
Concussion sufferers asked to abstain from screen time for first 48 hours of recovery
Intervention Type
Behavioral
Intervention Name(s)
Screen time permitted
Intervention Description
Cohort will not be directed to abstain from screen time
Intervention Type
Behavioral
Intervention Name(s)
Screen Time Abstain
Intervention Description
Cohort will be directed to abstain from screen time
Primary Outcome Measure Information:
Title
Duration of concussive symptoms
Description
The average number of days from initial concussion diagnosis until participant has a Post Concussive Symptom Scale Score (PCSS) of less than 7
Time Frame
From date of randomization until PCSS of less than 7 is achieved or up to 10 days, whichever comes first.
Secondary Outcome Measure Information:
Title
Number of specific symptoms (Day 1-3)
Description
The average total number of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant.
Time Frame
Day 1 to day 3
Title
Number of specific symptoms each day (Day 4-10)
Description
The average total number of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant.
Time Frame
Day 4 to day 10
Title
Severity of specific symptoms (Day 1-3)
Description
The average severity of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant.
Time Frame
Day 1 to day 3
Title
Severity of specific symptoms (Day 4-10)
Description
The average severity of symptoms as reported daily by participant on the Post Concussive Symptom Scale (PCSS) by participant.
Time Frame
Day 4 to day 10
Title
Amount of screen time use
Description
Average minutes of screen time (video games, television, computer, smartphone) as self-reported by participant on questionnaire.
Time Frame
Randomization to 48 hours.
Title
Days until return to school/work and sports
Description
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.
Time Frame
From date of randomization to return to school/work and sports, up to day 10.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Macnow, MD
Organizational Affiliation
UMASS Memorial Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34491285
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.
Results Reference
derived

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The Effect of Screen Time on Recovery From Concussion

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