What is the mechanism of action of this treatment?

Pregnenolone, a neurosteroid, modulates neurotransmission and provides neuroprotection by enhancing synaptic plasticity, reducing inflammation, and promoting myelination. This is crucial for TBI patients as it helps in repairing damaged neural pathways and reducing secondary brain injury. Similarly, glucocorticoids like methylprednisolone reduce inflammation and edema, which can mitigate further neuronal damage and improve functional recovery. These treatments are vital as they address both the immediate and long-term effects of TBI, potentially improving outcomes and quality of life for patients.

What side effects are associated with this type of intervention?

Common treatments for Traumatic Brain Injury (TBI) such as corticosteroids (e.g., methylprednisolone) are associated with side effects including hyperglycemia, increased susceptibility to infection, bone loss, fractures, and neuropsychiatric effects. Pregnenolone, a neurosteroid being studied for TBI, modulates neurotransmission and neuroprotection, but its specific side effects in TBI treatment are not well established.

What prior FDA approvals exist?

There are no specific FDA-approved neurosteroids like pregnenolone for the treatment of Traumatic Brain Injury (TBI). Current treatments for TBI primarily focus on managing symptoms and preventing secondary injury rather than direct neuroprotection or neurotransmission modulation. These treatments include supportive care, rehabilitation therapies, and medications to manage symptoms such as pain, seizures, and spasticity. Research is ongoing to explore the potential of neurosteroids and other neuroprotective agents in TBI treatment.

What other types of research exist?

Promising novel alternatives to pregnenolone for TBI patients include: 1) N-acetylcysteine (NAC), which has shown neuroprotective properties and potential in reducing oxidative stress and inflammation. 2) Hyperbaric Oxygen Therapy (HBOT), which has been studied for its ability to enhance neuroplasticity and improve cognitive function. 3) Platelet-Rich Plasma (PRP) therapy, which is being explored for its regenerative properties and potential to improve neurological outcomes. 4) Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), which may help in managing PTSD symptoms and improving mood. These alternatives are under investigation and may offer new avenues for treatment in 2024.

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Pregnenolone for Chronic Traumatic Brain Injury

Phase 2

Recruiting

Led By Chris Marx, MD

Research Sponsored by Christine Marx, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 8

Summary

This trial is testing whether pregnenolone can help improve mental and physical health in veterans with long-term brain injuries. Participants will take pregnenolone daily for a period of time. The study aims to see if pregnenolone is effective in improving health outcomes and to find the best safe dose.

Who is the study for?

This trial is for OEF/OIF/OND-era U.S. Military Veterans aged 21-65 with a history of mild TBI since 2001, who can read English and consent to the study. They must not plan to change psychiatric or pain meds during the study, have no recent psychotropic interventions, and if female and able to become pregnant, must use birth control.

What is being tested?

The trial tests whether pregnenolone improves psychological health, physical function, cognition, PTSD symptoms, and pain in veterans with chronic TBI compared to a placebo over eight weeks. It also examines biological effects of pregnenolone and its optimal safe dose.

What are the potential side effects?

Potential side effects are not detailed here but will be monitored at each visit. Participants should report any adverse reactions they experience which could include typical drug-related issues such as headaches, dizziness or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in psychological health as measured by the Brief Symptom Inventory-18 (BSI)

Secondary study objectives

Changes in PTSD symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5)

Changes in cognition as measured by the Stroop Color and Word Test (STROOP)

Changes in cognition as measured by the Wechsler Adult Intelligence Scale (WAIS-IV)

+4 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: PregnenoloneActive Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pregnenolone, a neurosteroid, modulates neurotransmission and provides neuroprotection by enhancing synaptic plasticity, reducing inflammation, and promoting myelination. This is crucial for TBI patients as it helps in repairing damaged neural pathways and reducing secondary brain injury. Similarly, glucocorticoids like methylprednisolone reduce inflammation and edema, which can mitigate further neuronal damage and improve functional recovery. These treatments are vital as they address both the immediate and long-term effects of TBI, potentially improving outcomes and quality of life for patients.

Advances in management of neurosurgical trauma: USA and Canada.