Brain InjuryBOOSTNCT07756060
Creatine Supplementation in Pediatric Brain Injury
A study testing Creatine monohydrate and Microcrystalline Cellulose in people with Brain Injury and Traumatic Brain Injury, run by Spaulding Rehabilitation Hospital.
Trial summary
A study examining the effects of creatine supplementation to improve recovery after brain injury in children and teenagers. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Brain Injury, Traumatic Brain Injury, Stroke
- What is being tested?
- Creatine monohydrate and Microcrystalline Cellulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: Creatine Supplementation in Pediatric Brain Injury: Brain Outcomes Optimization Through Supplementation Therapy
A study examining the effects of creatine supplementation to improve recovery after brain injury in children and teenagers.
Read the 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.
- Conditions
- Brain Injury, Traumatic Brain Injury, Stroke
- Being tested
- Creatine monohydrate, Microcrystalline Cellulose
- Keywords
- creatine, rehabilitation
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine monohydrateDietary supplement
12 weeks of creating monohydrate supplementation at 5 gm, twice per day
Microcrystalline CelluloseOther
Microcrystalline cellulose, which is an inert powder that is indistinguishable from creatine monohydrate in all sensory and procedural aspects, including appearance, taste, and solvability
| Study group | Role | What they receive |
|---|---|---|
| Creatine | Experimental | Not described Receives: Dietary Supplement: Creatine monohydrate |
| Control | Placebo comparator | Not described Receives: Other: Microcrystalline Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of subjects who enroll in the study compared to those who are approached for consent
Measured: 12 weeks
Attrition
Proportion of subjects who consent for study participation and exit from the study prior to completing 12 weeks of supplementation
Measured: 12 weeks
Retention
Proportion of subjects who enroll in the study and subsequently complete 12 weeks of supplementation.
Measured: 12 weeks
Dosing adherence
Proportion of prescribed supplement doses which are recorded to be taken across 12 weeks of supplementation.
Measured: 12 weeks
Secondary outcomes (5)
Creatinine
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.
Measured: 12 weeks
Cystatin C
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.
Measured: 12 weeks
Extended Glasgow Outcome Scale
Clinical scale used to assess overall functional outcome after traumatic brain injury. Ranges 1-8 with higher scores reflecting better recovery.
Measured: 12 months
Interhemispheric coherence
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).
Measured: 12 months
Cerebral blood flow velocity
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies 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
- Model description
- Placebo controlled, double blind trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer C, Wu, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756060
- Sponsor's protocol ID
- 2026P001727
- Acronym
- BOOST
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Supplementation in Pediatric Brain Injury: Brain Outcomes Optimization Through Supplementation Therapy
- ClinicalTrials.gov ID
- NCT07756060
- Acronym / sponsor ID
- BOOST / 2026P001727
- Conditions
- Brain Injury, Traumatic Brain Injury, Stroke
- Keywords
- creatine, rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 10 Aug 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo controlled, double blind trial
| Arm | Type | Receives |
|---|---|---|
| Creatine | Experimental | Dietary Supplement: Creatine monohydrate |
| Control | Placebo comparator | Other: Microcrystalline Cellulose |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Creatine monohydrate12 weeks of creating monohydrate supplementation at 5 gm, twice per day | Dietary supplement | Creatine |
| Microcrystalline CelluloseMicrocrystalline cellulose, which is an inert powder that is indistinguishable from creatine monohydrate in all sensory and procedural aspects, including appearance, taste, and solvability | Other | Control |
Primary outcome
Recruitment rate
Time frame: 12 weeks
Proportion of subjects who enroll in the study compared to those who are approached for consent
Attrition
Time frame: 12 weeks
Proportion of subjects who consent for study participation and exit from the study prior to completing 12 weeks of supplementation
Retention
Time frame: 12 weeks
Proportion of subjects who enroll in the study and subsequently complete 12 weeks of supplementation.
Dosing adherence
Time frame: 12 weeks
Proportion of prescribed supplement doses which are recorded to be taken across 12 weeks of supplementation.
5 secondary outcomes
Creatinine
Time frame: 12 weeks
Cystatin C
Time frame: 12 weeks
Extended Glasgow Outcome Scale
Time frame: 12 months
Interhemispheric coherence
Time frame: 12 months
Cerebral blood flow velocity
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine monohydrate and Microcrystalline Cellulose in people with Brain Injury and Traumatic Brain Injury, run by Spaulding Rehabilitation Hospital.
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 2 inclusion and 9 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: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Recruitment rate (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.