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PET-MRI for Traumatic Brain Injury (PET-MRIcTBI Trial)

N/A

Waitlist Available

Led By Andrew B. Newberg, MD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

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

Must have

Age 18-80 years old

Be older than 18 years old

Must not have

Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight > 350 pounds)

Patients that have a history of uncontrolled conditions, e.g.: diabetes, asthma, gastroesophageal reflex disease, or thyroid conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline in the primary study for waitlist and control groups, not in the net substudy.

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying whether using a specific type of MRI scan can help doctors better understand and treat chronic traumatic brain injury.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not detailed here, typical reactions might include discomfort from dietary changes, potential allergic responses to supplements like N-acetyl Cysteine, and emotional distress during NET therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have uncontrolled diabetes, asthma, GERD, or thyroid issues.

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I have had brain surgery before.

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I don't have brain conditions that could affect scan readings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 90 ± 30 days and 180 ± 30 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 90 ± 30 days and 180 ± 30 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 90 ± 30 days and 180 ± 30 days. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Fluorodeoxyglucose positron emission tomography (FDG-PET).

FMRI

Secondary study objectives

Beck Depression Inventory (BDI).

Blood plasma and serum analysis

Delis Kaplan Executive Function System (DKEFS) color-word interference.

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: Neuro Emotive Technique (NET)Active Control1 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 CohortActive Control1 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) CohortActive Control1 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 CohortActive Control1 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.

0 / 5Eligibility criteria met