An interventional study of Ketogenic Diet in Traumatic Brain Injury, sponsored by Gillette Children's Specialty Healthcare. Completed at 2 sites in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Gillette Children's Specialty Healthcare · Not applicable, Interventional, and Treatment
Among 908 studies in Brain Injuries, Traumatic with a site in United States — 211 open to participants now, 249 under way, 5 of them phase 3. Brain Injuries, Traumatic · United States.
Among the 908 studies in Brain Injuries, Traumatic with a site in United States, this one is the 584th largest by enrollment of the 649 interventional ones that give a count, is one of 33 that started in 2022, is one of 440 with no phase, and was the 656th registered.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
Browse Brain Injuries, Traumatic studies →211 of the 908 studies in Brain Injuries, Traumatic with a site in United States are open now. Recruiting first, the newest first:
Andrew Mayer · Sites in United States
Ages 18–82 · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 18–55
Columbia University · Sites in United States
Ages 18+
Columbia University · Sites in United States, Brazil, Canada and 2 more countries
Ages 18+
University of Michigan · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 281 Brain Injuries, Traumatic studies recruiting now, 120 (43%) set no upper age limit and 119 (42%) stop at 75 or younger; 40 take children under 18; 52 take healthy volunteers.
This study: 2 Years to 17 Years · all sexes · no healthy volunteers.
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908 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 65 · Phase 2 110 · Phase 3 39 · Phase 4 28
First in 1996; this study’s year is marked. 33 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 7 is below the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Median enrollment 50 across the 649 interventional studies, 120 across the 257 observational. Of the 553 that completed or were terminated, 182 (33%) have results posted.
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101 of 908 have an industry lead sponsor. The 10 most frequent:
Gillette Children's Specialty Healthcare is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Gillette Children's Specialty Healthcare has 1 study filed under Brain Injuries, Traumatic — fewer than ten, so there is no comparison to draw.
83 of the studies in Brain Injuries, Traumatic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06368648CoMind Technologies LimitedCoMind Early Feasibility Study | 2026-11 |
| NCT06103201University of Maryland, BaltimoreHyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury | 2026-11-26 |
| NCT07733284Kessler FoundationHome-Based Walking for Thinking Skills in Persons With TBI | 2026-12 |
| NCT06228391Minneapolis Veterans Affairs Medical CenterKetamine Treatment for PTSD and MDD in TBI | 2026-12 |
| NCT05702138Craig HospitalHigh Intensity Step Training After Traumatic Brain Injury | 2026-12 |
Add all 83 to your calendar (.ics) → With an account.
Among the 908 studies in Brain Injuries, Traumatic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary objective of this study is to evaluate the feasibility and safety of using the ketogenic diet (KD) in children who sustained moderate to severe traumatic brain injury (TBI). The secondary objective is a preliminary evaluation of the outcomes of children who have had the standard of care plus the KD, compared to those with standard of care alone. Outcome measures for the secondary objective will include: need for ventriculoperitoneal shunt, duration of unconsciousness, need for any type of craniotomy, duration of post-traumatic amnesia, acute hospitalization length of stay, and cognitive and motor function at 12 months after injury. If this study demonstrates feasibility and safety, the information related to outcomes will be used to inform the planning of a future, larger, randomized study of the efficacy of the KD in children and adolescents with TBI. Specifically, this information will be used to assist with sample size calculations for this future study.
The KD is an alternative feeding regimen that has been in use since 1921. It is a high fat, low carbohydrate and moderate protein diet. There are various forms of the KD. The classic KD consists of long-chain triglycerides with a fat-to-combined-protein-and-carbohydrate ratio that can vary. At our institution, it is standard of care to initiate a ketogenic diet at a ratio of 2:1, and to increase the ratio to 3:1 or 4:1 as needed to achieve ketosis. Clinically, the KD has been proven to be an effective therapy in children and adolescents with refractory epilepsy, as well as for those with type II diabetes. In addition, an international consensus was published in 2009 that recommended the use of the KD to treat epilepsy refractory as an alternative to at least two antiepileptic medications. Before initiating the KD for epilepsy management, labs such as urine and blood ketones, blood glucose and a basic metabolic panel including magnesium are commonly recommended. Risks for long-term use of the KD include but are not limited to the following: hypercholesterolemia, mineral deficiencies, acidosis, constipation, weight loss and nephrolithiasis. However, short-term use should significantly limit the occurrence of these potential complications.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive standard of care for acute management of moderate to severe traumatic brain injury, together with a weight-based ketogenic diet added for up to fourteen days.
Other: Ketogenic Diet
Medical records of past TBI patients will be used as controls matched for age, gender, socioeconomic status (type of health care coverage including private insurance vs. government-funded coverage), lowest first 24 hour post-injury Glasgow Coma Score (GCS) (\<8 or 8-12), and pre-injury school program (regular or special education).
The ketogenic diet (KD) is an alternative feeding regimen that has been in use since 1921. It is a high-fat, low carbohydrate, and moderate protein diet. There are various forms of the KD. The classic KD consists of long-chain triglycerides with a fat-to-combined-protein-and-carbohydrate ratio that can vary. At the investigating institution, it is standard of care to initiate a ketogenic diet at a ratio of 2:1, and to increase the ratio to 3:1 or 4:1 as needed to achieve ketosis.
Also known as: Keto
Ability to complete a course of the ketogenic diet (KD)
Safety and feasibility will be determined by the ability to complete a 14-day course of the KD after TBI without needing to terminate the diet due to intolerance resulting from gastrointestinal side effects (for example, nausea and vomiting, diarrhea, or acidosis), or due to abnormal findings on laboratory tests. Outcome is reported as the number of participants who complete the 14-day keto diet treatment.
Time frame: 14 days
Duration of Unconsciousness
Outcome is reported as the length of time (in hours) a participant is unconscious following their injury.
Time frame: 14 days
Need for Surgeries
Outcome is reported as the number of surgeries required in each group following injury.
Time frame: 14 days
Duration of Acute Hospitalization
Outcome is reported as the length (in days) of acute hospitalization following injury.
Time frame: 14 days
Duration of Post-traumatic Amnesia
Outcome is reported as the length of time (in days) that a participant experiences amnesia following their injury.
Time frame: 14 days
Plan to share: No — pilot, feasibility study only.
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Dec 2024, 31 months.
Of 442 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's 31 months is below that.
Counting every sponsor, half of 464 studies reached it within 40 months; a quarter within 22 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Gillette Children's Specialty Healthcare