PET-MRI for Traumatic Brain Injury

(PET-MRIcTBI Trial)

Recruiting 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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Chronic Traumatic Brain Injury (cTBI) symptoms exist in individuals who experienced previous traumatic brain injuries. There are 80-90 thousand individuals who are clinically diagnosed with cTBI, with estimated costs at greater than 60 billion dollars. However, there is a lack of studies using comprehensive diagnostic imaging tools to better understand physiological ramifications of the injury that may help guide therapy. This study uses integrative medicine approaches for persons with cTBI. Another aim of this study will be a continuation of this protocol in an effort to address the ongoing distressing physiological and psychological (anxiety and depression) symptoms associated with cTBI. After completion of the initial 3 study arms, the investigators have amended the protocol to evaluate the physiological and psychological effects and potential symptom improvement of integrative medicine approaches in cTBI patients using the Neuro Emotive Technique (NET). Participants may be re-enrolled in the NET group after completion of participation in the initial study arms. The participants in the NET substudy will be interviewed about Subjective Units of Distress (SUDS) associated with the cTBI event initially and after completion of the NET sessions.

Research Team

Andrew B. Newberg, MD

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+