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Ketogenic Diet for Traumatic Brain Injury
Study Summary
This trial is investigating whether a short-term ketogenic diet can improve neurocognitive outcomes following a moderate-severe TBI.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have severe difficulty speaking or understanding language.Your prealbumin levels are very low when you are admitted to the study.You have a history of a neurological disorder or surgery on the brain or nerves before getting sick.You have a low GCS score because of recent intoxication.You have had a stroke caused by reduced blood flow to the brain after a serious head injury.You have high cholesterol.You have certain metabolic disorders that make it unsafe for you to follow a ketogenic diet.You have a history of brain injury with loss of consciousness.You have a history of mental health issues.You have severe kidney problems.You had surgery on your abdomen during this hospital stay.You have type 1 diabetes.You have a condition called gastroparesis.You have metal implants, are pregnant, have claustrophobia, or can't have an MRI for other medical reasons.Your liver enzymes are more than 5 times the normal level, or you have chronic cirrhosis.You have had a serious head injury within the past month.
- Group 1: TBI KD/MAD
- Group 2: TBI SD
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there openings remaining in the experiment for participants?
"Unfortunately, clinicaltrials.gov reports that this trial is no longer accepting applicants as it was initially posted on December 7th 2020 and last updated on September 19th 2022. Despite this setback, there are 902 other trials still searching for enrollees at the present time."
What is the primary purpose of this clinical investigation?
"The primary outcome evaluated over the 0 to 6 month period of this clinical trial is neurological improvement. Secondary outcomes include Neurocognitive changes, as measured by Delis Kaplan Executive Function System (D-KEFS), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Trail Making Test, Part B; all three being assessed across a 6 month time frame."
Am I able to join the research project?
"Patients between the ages of 18 and 90 who have sustained wounds are eligible to take part in this study. They must also present with moderate (GCS 9-12) or extreme (GCS ≤ 8) traumatic brain injury, having occurred within 2-30 days prior to admission at LLU East Campus unit 1100 for acute rehabilitation services. The trial is limited to 30 participants only."
Is there an upper age limit for enrolment in this investigation?
"According to the set parameters for this clinical trial, applicants must be 18 or above, and cannot exceed 90 years old."
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