Concussion, BrainNCT03564210
The Effect of Screen Time on Recovery From Concussion
A study testing Screen time permitted and Screen Time Abstain in people with Concussion, Brain, run by Theodore Macnow at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- Screen time permitted and Screen Time Abstain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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,
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
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).
- Conditions
- Concussion, Brain
- Being tested
- Screen time permitted, Screen Time Abstain
- Keywords
- screen time
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screen time permittedBehavioural
Cohort will not be directed to abstain from screen time
Screen Time AbstainBehavioural
Cohort will be directed to abstain from screen time
| Study group | Role | What they receive |
|---|---|---|
| Screen time permitted | Active comparator | Concussion sufferers permitted screen time for first 48 hours of recovery Receives: Behavioral: Screen time permitted |
| Screen time abstain | Active comparator | Concussion sufferers asked to abstain from screen time for first 48 hours of recovery Receives: Behavioral: Screen Time Abstain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
The average total number of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant.
Measured: Day 1 to day 3
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.
Measured: Day 4 to day 10
Severity of specific symptoms (Day 1-3)
The average severity of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant.
Measured: Day 1 to day 3
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.
Measured: Day 4 to day 10
Amount of screen time use
Average minutes of screen time (video games, television, computer, smartphone) as self-reported by participant on questionnaire.
Measured: Randomization to 48 hours.
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.
Measured: From date of randomization to return to school/work and sports, up to day 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start7 May 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodore Macnow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Theodore Macnow, University of Massachusetts, Worcester
- Investigators
- Theodore Macnow, MD, Principal investigator, UMass Memorial Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564210
- Sponsor's protocol ID
- H00014355
- Status last verified
- Nov 2020
- First submitted
- 23 May 2018
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34491285
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Screen Time on Recovery From Concussion
- ClinicalTrials.gov ID
- NCT03564210
- Acronym / sponsor ID
- H00014355
- Conditions
- Concussion, Brain
- Keywords
- screen time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Theodore MacnowUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screen time permitted | Active comparator | Behavioral: Screen time permittedConcussion sufferers permitted screen time for first 48 hours of recovery |
| Screen time abstain | Active comparator | Behavioral: Screen Time AbstainConcussion sufferers asked to abstain from screen time for first 48 hours of recovery |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screen time permittedCohort will not be directed to abstain from screen time | Behavioural | Screen time permitted |
| Screen Time AbstainCohort will be directed to abstain from screen time | Behavioural | Screen time abstain |
Primary outcome
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
6 secondary outcomes
Number of specific symptoms (Day 1-3)
Time frame: Day 1 to day 3
Number of specific symptoms each day (Day 4-10)
Time frame: Day 4 to day 10
Severity of specific symptoms (Day 1-3)
Time frame: Day 1 to day 3
Severity of specific symptoms (Day 4-10)
Time frame: Day 4 to day 10
Amount of screen time use
Time frame: Randomization to 48 hours.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Derived from this study: PubMed 34491285Macnow 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.
- Individual participant dataSharing planned: No
Related trials for Concussion, Brain
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore Macnow, MD principal investigator
UMass Memorial Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screen time permitted and Screen Time Abstain in people with Concussion, Brain, run by Theodore Macnow at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03564210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.