Brain Injury, Stroke, Traumatic Brain Injury
Conditions
Keywords
creatine, rehabilitation
Brief summary
A study examining the effects of creatine supplementation to improve recovery after brain injury in children and teenagers.
Detailed description
A 12-week creatine vs placebo supplementation trial in pediatric patients admitted to inpatient rehabilitation with new functional impairments due to brain injury. Effects will be monitored with labs, electroencephalography, transcranial doppler ultrasonography, and clinical assessment.
Interventions
DIETARY_SUPPLEMENTCreatine monohydrate
12 weeks of creating monohydrate supplementation at 5 gm, twice per day
OTHERMicrocrystalline Cellulose
Microcrystalline cellulose, which is an inert powder that is indistinguishable from creatine monohydrate in all sensory and procedural aspects, including appearance, taste, and solvability
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Placebo controlled, double blind trial
Eligibility
Sex/Gender
ALL
Age
8 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* History of subacute moderate-to-severe brain injury resulting in a new functional impairment, as defined by: Glasgow Coma Scale score (GCS) \< 13 points * Subacute brain injury is defined to be \< 3 months since index injury
Exclusion criteria
* Weight \< 25 kg * History pre-existing chronic kidney disease (CKD stage ≥ 2), prior kidney transplantation, previous dialysis dependence, or solitary kidney status * Premorbid (pre-brain injury) eGFR \< 60 * Inability to obtain regular phlebotomy for any reason * Known inborn errors of mitochondrial function * Premorbid history of significant head trauma or brain injury requiring hospitalization * Pregnancy * Concurrent malignancy * Any other current, serious, chronic medical or psychiatric disease that in the PI's judgment may interfere with study participation or data integrity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 12 weeks | Proportion of subjects who enroll in the study compared to those who are approached for consent |
| Attrition | 12 weeks | Proportion of subjects who consent for study participation and exit from the study prior to completing 12 weeks of supplementation |
| Retention | 12 weeks | Proportion of subjects who enroll in the study and subsequently complete 12 weeks of supplementation. |
| Dosing adherence | 12 weeks | Proportion of prescribed supplement doses which are recorded to be taken across 12 weeks of supplementation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine | 12 weeks | Serum based marker of kidney function, commonly checked as part of a standard basic metabolic panel in outpatient and inpatient medical settings. Normal range is 0.3-1.59 mg/dL depending on age and gender. |
| Cystatin C | 12 weeks | Small protein filtered nearly entirely by kidney and can be measured in blood serum levels as a marker of kidney function. Healthy reference range is 0.6-1.0 mg/L. |
| Extended Glasgow Outcome Scale | 12 months | Clinical scale used to assess overall functional outcome after traumatic brain injury. Ranges 1-8 with higher scores reflecting better recovery. |
| Interhemispheric coherence | 12 months | Quantitatie electroencephalography (EEG) measure that assess the degree of synchronization between electrical signals recorded from corresponding Right and Left brain regions. It ranges 0-1 with 1 reflecting perfect synchronization (or maximum functional connectivity). |
| Cerebral blood flow velocity | 12 months | Speed of blood flow through major intracranial arteries (middle cerebral artery in the current study), measured noninvasively using Doppler ultrasound. Typical mean middle cerebral artery velocity is 30-80 cm/s in healthy adults. |
Outcome results
None listed