PET-MRI for Traumatic Brain Injury

(PET-MRIcTBI Trial)

Enrolling by invitation at 1 trial location

Overseen By Nancy Wintering, LCSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Previous brain surgery, Intracranial abnormalities, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new ways to understand and treat the long-term effects of traumatic brain injury (TBI). Participants will try different treatments, including the Neuro Emotive Technique (NET), a natural supplement called N-acetyl cysteine (NAC), and an anti-inflammatory diet, to determine their effectiveness in alleviating ongoing symptoms like headaches and emotional issues. Individuals who have experienced a TBI and continue to face lingering symptoms, such as cognitive or emotional challenges, are well-suited for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially find relief from persistent TBI symptoms.

Do I have to stop taking my current medications for the trial?

You can continue taking your current medications or supplements, but you need to be on a stable dose for at least one month before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments under study for chronic traumatic brain injury (cTBI) have been tested for safety in humans in various contexts.

For the Neuro Emotive Technique (NET), although specific safety data for cTBI is lacking, similar brain stimulation techniques have demonstrated safety in other studies. These methods are often used in rehabilitation without major safety issues, suggesting they might be safe for cTBI patients as well.

N-acetyl cysteine (NAC), another treatment in the trial, is a common over-the-counter supplement. Studies have shown it is used safely for conditions like acetaminophen overdose. In research on brain injuries, NAC has been used without reported side effects, indicating it appears safe.

The anti-inflammatory diet component of the trial aims to reduce inflammation through dietary changes. Studies have shown that diets rich in fruits and vegetables are generally safe and can help reduce inflammation and related symptoms.

Overall, these treatments are considered safe based on existing studies and their use in other situations. Participants should feel reassured by this evidence, but discussing any concerns with the study team remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments in this trial for traumatic brain injury (TBI) because they each offer a unique approach to healing. The Neuro Emotive Technique (NET) stands out by focusing on neurocognitive and emotional aspects, using biofeedback and imaging to assess its effects on distress and inflammation. The N-acetyl Cysteine (NAC) cohort introduces a natural supplement known for its antioxidant properties, aiming to reduce oxidative damage, a common issue in neurodegenerative disorders like TBI. Lastly, the Anti-inflammatory Diet (AID) cohort emphasizes dietary changes to lower inflammation, focusing on reducing saturated fats and boosting omega-3 intake. These diverse strategies offer new avenues for managing TBI, each targeting different aspects of the condition.

What evidence suggests that this trial's treatments could be effective for chronic traumatic brain injury?

This trial will compare the effectiveness of different treatments for traumatic brain injury (TBI). Research has shown that the Neuro Emotive Technique (NET), one of the treatments in this trial, may enhance emotional well-being in people with TBI by using methods that help the brain adjust and heal, potentially reducing symptoms like anxiety and depression.

Another treatment option in this trial is N-acetyl cysteine (NAC). Studies suggest that NAC can protect brain function by reducing damage from harmful molecules called free radicals. Specifically, NAC has improved symptoms and protected the brain in TBI patients.

The trial also includes an anti-inflammatory diet arm, which involves consuming fewer foods that cause inflammation. This diet has been linked to better brain function and fewer symptoms after a brain injury, focusing on healthy fats and proteins that support brain health. Each of these treatments may help manage ongoing TBI symptoms. ^{2 4 6 7 8}

Who Is on the Research Team?

Andrew B. Newberg, MD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with a history of traumatic brain injury (TBI) and ongoing symptoms like cognitive issues or emotional disturbances. They must not have significant pre-TBI medical conditions, be able to consent, and if on medication or supplements, they should be on a stable dose for at least one month. Pregnant women, those with metal implants that affect MRI scans, or individuals who've had recent experimental therapies are excluded.

Inclusion Criteria

Able to give informed consent and willing to complete the study

I am a woman who can have children and have a negative pregnancy test.

I experience anxiety or distress related to my brain injury.

Exclusion Criteria

Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging

I cannot stay still in a scanner due to claustrophobia or because I weigh over 350 pounds.

I have had brain surgery before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Evaluation

Participants undergo a comprehensive diagnostic evaluation using neurocognitive tests, laboratory tests, and PET-MRI imaging

Baseline

1 visit (in-person)

Treatment

Participants receive treatment based on their assigned cohort: Neuro Emotive Technique, NAC supplementation, or Anti-inflammatory Diet

3 months

Weekly visits for NAC cohort, 5 sessions for NET cohort

Follow-up

Participants are monitored for changes in physiological and psychological symptoms using follow-up MRI, neurocognitive tests, and biofeedback measures

3-6 months

2 visits (in-person)

Open-label extension (optional)

Participants may opt into continuation of treatment long-term to further evaluate the effects of the Neuro Emotive Technique

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Anti-inflammatory Diet
• N-acetyl Cysteine
• Neuro Emotive Technique

Trial Overview The study explores the effects of integrative medicine approaches in chronic TBI patients using Neuro Emotive Technique (NET), an anti-inflammatory diet, and N-acetyl Cysteine supplementation. It aims to understand how these interventions can alleviate physiological and psychological symptoms associated with cTBI.

How Is the Trial Designed?

Group I: Neuro Emotive Technique (NET) Active Control 1 Intervention

Eligible participants would be evaluated (or re-evaluated) receive neurocognitive tests, and receive baseline PET-MRI and follow up MRI imaging; pre-screening measures distress by the Subjective Units of Distress interview, biofeedback measures of heart rate variability (HRV) and galvanic skin resistance (GSR) and Baseline and post NET blood plasma and serum analysis to measure inflammation and immune function. Participants from the initial study will be re-consented if enrolled in the Neuro Emotive Technique Substudy. SUDS, biofeedback and surveys, MRI imaging and blood draws will be completed again after the 5 NET sessions are complete.

Group II: Intravenous/Oral NAC Cohort Active Control 1 Intervention

N-acetyl Cysteine: This arm provide patients with a natural supplement, n-acetyl cysteine (NAC) which is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine, that supports antioxidants to reduce oxidative damage in the body. NAC is a common over-the-counter supplement.Laboratory studies have suggested that NAC might have a beneficial effect in neurodegenerative disorders such as TBI. Patients in this arm will receive IV NAC once a week plus oral NAC supplement 500 mg twice per day for approximately 3 months until the follow up evaluation.

Group III: Dietary (AID) Cohort Active Control 1 Intervention

Anti-inflammatory Diet: This arm will focus on adjusting dietary practices to eat foods that have lower amounts of inflammatory foods that might help reduce overall inflammation in the brain and body. This arm will introduce patients to an integrative diet that reduces saturated fats and carbohydrates and emphasizes proteins and omega-3 fats that help reduce inflammation and oxidative damage.

Group IV: Control Cohort Active Control 1 Intervention

Control Group: Standard of Care Treatment for at least 3 months. After the first 3 month, participants in this arm may crossover to the NAC study arm.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10506931/

Brain Injury: How Dietary Patterns Impact Long-Term Outcomes The benefits of a plant-based diet (including CVD protection), likely arise from increased fiber, lower saturated, and unhealthy fats, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6412510/

Reduced Neuroinflammation and Improved Functional ... Results demonstrated that mice fed the diets had improved neuromotor function, reduced lesion volume, increased neuronal density in the hippocampus and reduced ...

3. med.unc.edu med.unc.edu/phyrehab/uncategorized/new-research-finds-changing-your-diet-could-ease-persistent-headaches-after-brain-injury/

New Research Finds Changing Your Diet Could Ease ... A new clinical trial demonstrates that dietary changes significantly reduce persistent post-traumatic headaches (pPTH), a common and debilitating consequence ...

4. researchgate.net researchgate.net/publication/372135956_Brain_Injury_How_Dietary_Pattens_Impact_Long-Term_Outcomes

(PDF) Brain Injury: How Dietary Pattens Impact Long-Term ... This review discusses dietary patterns as a means of addressing modifiable risk factors following TBI exposure. Evidence-based resources for ...

5. mdpi.com mdpi.com/2072-6643/17/14/2269

Mediterranean Diet, Inflammation, and Neurovulnerability Currently, there is a noticeable erosion of the Mediterranean Diet, which is well established as the most effective nutritional pattern to counteract chronic ...

6. link.springer.com link.springer.com/article/10.1007/s40141-023-00413-7

Brain Injury: How Dietary Patterns Impact Long-Term ... This review discusses dietary patterns as a means of addressing modifiable risk factors following TBI exposure. Evidence-based resources for ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK597377/

Anti-Inflammatory Diets - StatPearls - NCBI Bookshelf - NIH Consistent evidence demonstrates that healthy dietary habits, including anti-inflammatory diets, decrease overall risk, morbidity, and mortality ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0889159124003611

Mediterranean diet protects against a neuroinflammatory ... Mediterranean diets may be neuroprotective and prevent cognitive decline relative to Western diets; however, the underlying biology is poorly understood.