Clinical trials: Pediatric Mild Traumatic Brain Injury
Concussion, Mild
Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion
The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the sub-acute period after concussion, and to document the…
- Trial name
- Breathe (NCT06559865)
- Testing
- Breathing exercises
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Sports Related Concussion
Concussion Goody Bag Study
For the pilot study, thirty eligible participants will be provided a concussion goody bag at their initial concussion evaluation visit.
- Trial name
- NCT07884604
- Where
- United States
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Children, Only, Traumatic Brain Injury
Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion
EEG signals have been collected and studied since the early 1990's as a way of assessing brain function at a gross level. As early as the 1930's a derivative of the raw EEG signal - event-related potentials (ERPs) - have been…
- Conditions
- Children, Only, Traumatic Brain Injury, Concussion, Mild, Pediatric ALL
- Trial name
- NCT03889483
- Testing
- NeuroCatch™ Platform
- Where
- Canada
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Dr. Michael Esser
Brain Concussion
Active Injury Management (AIM) After Pediatric Concussion
The proposed interventions of this study will determine the ideal discharge recommendations related to activity
- Trial name
- AIM (NCT03869970)
- Testing
- REST, ACTIVITY, mHEALTH
- Where
- 2 sites in United States
- Volunteers
- 237 people
- Sponsor
- Medical College of Wisconsin
Concussions, Mild Traumatic Brain Injury, Concussion
Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury
Formal MBIs, such as Mindfulness-Based Stress Reduction (MBSR), have been shown to increase resiliency and teach affect regulation.
- Conditions
- Concussions, Mild Traumatic Brain Injury, Concussion, Concussion Mild
- Trial name
- MBI-4-mTBI (NCT07272941)
- Testing
- Mindfulness Based Intervention (MBI)
- Where
- 5 sites in Canada
- Volunteers
- 362 people
- Sponsor
- Children's Hospital of Eastern Ontario
Mild Traumatic Brain Injury, Concussion
Neurocognitive Evaluation of Mild Traumatic Brain Injury in the Hospitalized Pediatric Population
Brain injuries from trauma are common in children, often resulting in death and disability. Most brain injuries are minor, yet their treatment can be challenging.
- Trial name
- NCT00715949
- Testing
- Immediate Post-concussion Assessment and Cognitive Testing
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Children's Hospital of Philadelphia
Concussion, Mild, Concussion, Brain
Acute Concussion and Melatonin
In this study, the investigator plans a randomized trial of melatonin versus placebo post acute pediatric concussion. The investigator hypothesizes that patients with acute concussions managed with melatonin will have improved…
- Conditions
- Concussion, Mild, Concussion, Brain, Pediatric ALL
- Trial name
- NCT04731974
- Testing
- Melatonin 3 MG
- Where
- United States
- Volunteers
- 254 people, healthy volunteers welcome
- Sponsor
- Children's National Research Institute
Concussion, Mild Traumatic Brain Injury
Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion (Acute Phase)
The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the acute period after concussion.
- Trial name
- Breathe - PED (NCT07572734)
- Testing
- Paced breathing exercises
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Concussion, Brain, Concussion, Mild
Mobile Subthreshold Exercise Program for Concussion--R01
Approximately 1.9 million youth sustain a concussion each year, and up to 30% experience persistent post-concussive symptoms (PPCS) such as headache, dizziness, and difficulty focusing that continue for weeks or months.
- Conditions
- Concussion, Brain, Concussion, Mild, Brain Injuries, Traumatic, Persistent Post Traumatic Headache
- Trial name
- MSTEP-R01 (NCT04688255)
- Testing
- MSTEP, Stretching
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Seattle Children's Hospital
Concussion, Mild Traumatic Brain Injury
DHA For The Treatment of Pediatric Concussion Related to Sports Injury
In recent years, media attention has focused on the long-term sequelae of repeated concussive episodes in professional athletes.
- Trial name
- NCT01903525
- Testing
- Docosahexaenoic acid (DHA)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Texas Southwestern Medical Center
Concussion Post Syndrome, Headaches Posttraumatic
Pediatric Concussion Outcomes
This is a randomized, placebo-controlled, double-blinded trial in which subjects with a post concussive headache meeting inclusion criterion will be assigned to one of two treatment groups: placebo or nortriptyline.
- Conditions
- Concussion Post Syndrome, Headaches Posttraumatic, Mild Traumatic Brain Injury
- Trial name
- PeCon (NCT04226365)
- Testing
- Nortriptyline
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Lancaster General Hospital
Mild Traumatic Brain Injury, Pediatric Traumatic Brain Injury
Kids Injury Detection Study Using the i-STAT
KIDS-STAT is a prospective study evaluating whether a rapid blood test measuring the brain injury biomarkers GFAP and UCH-L1 using the i-STAT Alinity system can help identify children with mild traumatic brain injury who do not…
- Conditions
- Mild Traumatic Brain Injury, Pediatric Traumatic Brain Injury, Head Trauma
- Trial name
- KIDS-STAT (NCT07835919)
- Testing
- i-STAT TBI Cartridge with the i-STAT Alinity System
- Volunteers
- 700 people
- Sponsor
- Children's Healthcare of Atlanta
Traumatic Brain Injury, Brain Concussion
Ondansetron for Pediatric Mild Traumatic Brain Injury
Background: Most patients suffering from mild Traumatic Brain Injury (mTBI) present persistent symptoms at one week post injury. A systematic review showed a paucity of studies for short term outcomes following mTBI.
- Trial name
- NCT01815125
- Testing
- Ondansetron
- Where
- Canada
- Volunteers
- 16 people
- Sponsor
- St. Justine's Hospital
Pediatric ALL, Concussion, Mild
Concussion Active Rehabilitation
In this study, the investigator plans a randomized trial of active rehabilitation and standard care for acute concussion management.
- Conditions
- Pediatric ALL, Concussion, Mild, Concussion, Brain, Concussion, Intermediate
- Trial name
- NCT04248218
- Testing
- Active Rehabilitation Group/Case
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Children's National Research Institute
Concussion, Brain, Concussion, Mild
The Role of Cerebral Oximetry in Pediatric Concussion Assessment
The purpose of this study is to determine whether there is a difference in cerebral oxygenation as measured by near-infrared spectroscopy (NIRS) in children with concussion and healthy controls.
- Conditions
- Concussion, Brain, Concussion, Mild, Traumatic Brain Injury
- Trial name
- NCT02036333
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Concussion, MTBI - Mild Traumatic Brain Injury
Online Treatment Recovery Assistance for Concussion in Kids
The investigators propose to develop a software platform, OnTRACK (Online Treatment Recovery Assistance for Concussion in Kids), for children and adolescents recovering from concussion or mild traumatic brain injury (mTBI).
- Trial name
- OnTRACK (NCT05065099)
- Testing
- Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK)
- Where
- United States
- Volunteers
- 408 people
- Sponsor
- Children's National Research Institute
Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury
BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)
Traumatic brain injury (TBI) is defined as a structural alteration of brain function caused by external causes, where mild traumatic brain injury (mTBI) represents approximately 80% of all TBI, and although its prognosis is…
- Trial name
- BIOTRABIS (NCT04641767)
- Where
- 9 sites in Spain
- Volunteers
- 200 people
- Sponsor
- Hospital Universitario Virgen Macarena
Concussions, Post-Concussive Symptoms
Pediatric Concussion Assessment of Rest and Exertion
The goal of this study is to investigate when is the best time to resume physical activity following a head injury. Two treatment plans will be studied; the first treatment plan consists of gradually reintroducing physical…
- Trial name
- PedCARE (NCT02893969)
- Testing
- Physical Activity, Rest
- Where
- Canada
- Volunteers
- 456 people
- Sponsor
- Children's Hospital of Eastern Ontario
Mild Traumatic Brain Injury, Concussion
Effect of Early Rest on Recovery From Pediatric Concussion
The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion.
- Conditions
- Mild Traumatic Brain Injury, Concussion, Post-concussive Syndrome
- Trial name
- NCT01101724
- Testing
- Mandated Rest, Intervention
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Medical College of Wisconsin
Head Injury, Minor, Pediatric
Hypertonic Saline for Mild TBI in Pediatric Patients
The purpose of this study is to compare two different treatments (normal saline and hypertonic saline) for concussions to see if one makes more of a difference in symptoms that can occur following concussions.
- Conditions
- Head Injury, Minor, Pediatric, Emergency Department Patient
- Trial name
- NCT07060105
- Testing
- Hypertonic Saline ( 3% Sodium Chloride Saline), Normal Saline (0.9% NaCl)
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- University of Texas at Austin