Ovidrel for Traumatic Brain Injury

(COGNI-REHAB Trial)

This trial tests a treatment called Ovidrel (a hormone injection) for men who have experienced a moderate to severe traumatic brain injury (TBI) within the last 1 to 6 months. The researchers aim to determine if Ovidrel, administered twice a week for 24 weeks, is safe and effective for cognitive and functional recovery. Participants will receive either Ovidrel or a placebo to compare results. Suitable candidates for this trial are men who have recently had a TBI, are fluent in English, and can commit to the 24-week treatment and follow-up evaluations. As an Early Phase 1 trial, this research focuses on understanding how Ovidrel works in people, offering participants the opportunity to contribute to groundbreaking insights into TBI recovery.

The trial does not specify that you must stop taking your current medications, but you need to be on stable doses of any medication that affects brain function unless your doctor says it's necessary for your health. If you're taking medications that affect sex hormones, like testosterone, you must have stopped them at least three months before joining the trial.

Previous studies have shown that Ovidrel (choriogonadotropin alfa) is safe for various medical conditions, including fertility treatments. Most people tolerate it well, though some report side effects like mild pain at the injection site, headaches, or nausea. More serious side effects are rare but can include ovarian hyperstimulation syndrome (OHSS), where the ovaries become swollen.

Unlike standard treatments for traumatic brain injury, which often focus on managing symptoms through medications like anti-seizure drugs or diuretics, Ovidrel offers a different approach. Ovidrel is unique because it uses the hormone human chorionic gonadotropin (hCG) to potentially promote brain repair and recovery. Administered subcutaneously, this experimental treatment could stimulate the body's natural healing processes, offering hope for more effective recovery from brain injuries. Researchers are excited about the potential of Ovidrel to target underlying mechanisms of brain repair rather than just alleviating symptoms.

This trial will evaluate Ovidrel's effectiveness for traumatic brain injury (TBI). Studies have shown that human chorionic gonadotropin (hCG), the active ingredient in Ovidrel, may aid recovery after a TBI. Although specific data on Ovidrel's effectiveness for TBI is limited, researchers believe it helps by influencing hormone levels that support brain recovery. Early research suggests that hCG might improve thinking and daily functioning, often affected by TBI. Ovidrel's ability to mimic natural hormones might support the brain's healing process. More studies are needed to confirm these effects in people with TBI, but initial findings are promising.¹²³⁶⁷