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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 90 ± 30 days and 180 ± 30 days.
Awards & highlights
PET-MRIcTBI Trial 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.Check my eligibility
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.See study design
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.
PET-MRIcTBI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
PET-MRIcTBI Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fluorodeoxyglucose positron emission tomography (FDG-PET).
Secondary outcome measures
Beck Depression Inventory (BDI).
Delis Kaplan Executive Function System (DKEFS) color-word interference.
Epworth Sleepiness Scale.
+10 morePET-MRIcTBI Trial Design
4Treatment groups
Active Control
Group I: Neuro Emotive TechniqueActive Control1 Intervention
This arm measures effects of NET in individuals with TBI symptoms by evaluating measures of distress, autonomic reactivity, neuroimaging markers, anxiety, health-related, physiological and psychology-related symptoms. Participants would be evaluated (or re-evaluated) with a battery of neurocognitive tests, and receive baseline PET-MRI and follow up MRI imaging. Subjects will receive a pre-screening evaluation that measures distress by the Subjective Units of Distress interview, biofeedback measures of heart rate variability (HRV) and galvanic skin resistance (GSR) in conjunction with recollection of distress. Subjects will receive five sessions of Neuro-emotive Technique. Subjects who have participated in the initial study will be re-consented if enrolled in the Neuro Emotive Technique Substudy for approximately 2-3 months until the follow up evaluation. SUDS, biofeedback and surveys will be completed again after the 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. It is used as an injectable pharmaceutical to protect the liver in cases of acetaminophen overdose. 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.
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
444 Previous Clinical Trials
145,474 Total Patients Enrolled
Andrew B. Newberg, MDPrincipal InvestigatorThomas Jefferson University
3 Previous Clinical Trials
96 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who can have children and have a negative pregnancy test.I experience anxiety or distress related to my brain injury.I am between 18 and 80 years old.I have had a traumatic brain injury and still experience symptoms like memory issues, mood changes, or headaches.I cannot stay still in a scanner due to claustrophobia or because I weigh over 350 pounds.I have been on a stable dose of my current medications or supplements for at least 1 month.I have had brain surgery before.I do not have any health conditions that affect my brain function.My current medications will be reviewed for interactions with the study's treatment.I have minor health issues like controlled high blood pressure or diabetes.I do not have uncontrolled diabetes, asthma, GERD, or thyroid issues.I don't have brain conditions that could affect scan readings.
Research Study Groups:
This trial has the following groups:- Group 1: Neuro Emotive Technique
- Group 2: Intravenous/Oral NAC Cohort
- Group 3: Dietary (AID) Cohort
- Group 4: Control Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any necessary prerequisites to participate in this experiment?
"This clinical trial is enlisting 120 individuals who experienced a traumatic brain injury and are between 18-80 years old. Essential eligibility criteria include no prior medical, neurological or psychological disorders (e.g., schizophrenia or active substance abuse); the participant must be stable for at least one month on their current medication/supplement regimen; minor, manageable health issues that should not affect cerebral blood flow can still be accepted (for instance controlled hypertension and medicated diabetes). Additionally, women of childbearing age need to take a pregnancy test while men with partners in this category also have to practice contraceptive methods. Lastly, persons with lingering TBI symptoms such as"
Answered by AI
Is eligibility for this experiment confined to adults?
"This trial requires that participants be between 18 and 80 years of age, with 156 studies for minors and 703 trials available to elderly patients."
Answered by AI
Does this scientific experiment still require more participants?
"The data hosted on clinicaltrials.gov indicates that this particular medical experiment is not recruiting patients at the moment. Originally posted in June 2017 and last edited July 11th 2022, no new recruits are being sought currently; however, 902 other trials actively need participants."
Answered by AI
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