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Trial record 25 of 315 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

PET-MRI and the Effect of N-Acetyl Cysteine (NAC) and Anti-Inflammatory Diet in Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03241732
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

July 11, 2017
August 7, 2017
January 17, 2018
June 7, 2017
February 10, 2020   (Final data collection date for primary outcome measure)
Fluorodeoxyglucose positron emission tomography (FDG-PET). [ Time Frame: Baseline in all study arms. ]
To measure inflammation and oxidative damage in the brain.
Same as current
Complete list of historical versions of study NCT03241732 on ClinicalTrials.gov Archive Site
  • Quantitative EEG. [ Time Frame: Baseline, 90 ± 30 days and 180 ± 30 days. ]
    This analysis will be used to help determining accurate origin of electrical signals in brain.
  • Functional magnetic resonance imaging (fMRI). [ Time Frame: Baseline, 90 ± 30 days and 180 ± 30 days. ]
    This scan will be used to assess functional connectivity, tractography, and brain volume.
  • Speilberger State Trait Anxiety Inventory (STAI). [ Time Frame: Baseline, 90 ± 30 days and 180 ± 30 days. ]
    This assessment questionnaire will be used as one of the psychological evaluation questionnaires for the study.
  • Profile of Moods Scale (POMS). [ Time Frame: Baseline, 90 ± 30 days and 180 ± 30 days. ]
    This assessment questionnaire will be used as one of the psychological evaluation questionnaires for the study.
  • Beck Depression Inventory (BDI). [ Time Frame: Baseline, 90 ± 30 days and 180 ± 30 days. ]
    This assessment questionnaire will be used as one of the psychological evaluation questionnaires for the study.
  • Delis Kaplan Executive Function System (DKEFS) color-word interference. [ Time Frame: Baseline, 90 ± 30 days and 180 ± 30 days. ]
    This assessment questionnaire will be used as one of the cognitive testings for the study.
  • Trails A & B. [ Time Frame: Baseline, 90 ± 30 days and 180 ± 30 days. ]
    This assessment questionnaire will be used as one of the cognitive testings for the study.
  • Forward and reverse digit span. [ Time Frame: Baseline, 90 ± 30 days and 180 ± 30 days. ]
    This assessment questionnaire will be used as one of the cognitive testings for the study.
  • Epworth Sleepiness Scale. [ Time Frame: Baseline, 90 ± 30 days and 180 ± 30 days. ]
    This assessment questionnaire will be used as one of the quality of life measures for the study.
  • Mayo-Portland Adaptability Inventory-4. [ Time Frame: Baseline, 90 ± 30 days and 180 ± 30 days. ]
    This assessment questionnaire will be used as one of the quality of life measures for the study.
  • Rivermead Post-Concussion Symptoms Questionnaire. [ Time Frame: Baseline, 90 ± 30 days and 180 ± 30 days. ]
    This assessment questionnaire will be used as one of the quality of life measures for the study.
Same as current
Not Provided
Not Provided
 
PET-MRI and the Effect of N-Acetyl Cysteine (NAC) and Anti-Inflammatory Diet in Traumatic Brain Injury
Defining Neurobiological Signatures for Chronic Traumatic Brain Injury Using PET-MRI
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.
The purpose of this project will be to create a comprehensive, extensive, longitudinal diagnostic evaluation of cTBI patients. The evaluation uses a battery of neurocognitive tests, laboratory levels of specific inflammatory compounds, and functional MRI, PET, and quantitative EEG. Participants shall be evaluated with this overall test battery initially, and then at approximately 3 and 6 months to determine the time course of changes within the brain associated with an integrative medicine approach. Three groups of participants will be enrolled in the study: anti-inflammatory diet group, a group who receive N-acetyl cysteine, and control group. NAC, is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement that is also available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. Laboratory studies have displayed some benefits to use of NAC. It has the potential to reduce markers of oxidative damage, protect against cell death, and to increase glutathione in blood, which might be useful in preventing oxidative damage in TBI patients.
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

There are two intervention arms of the study. One arm will focus on adjusting dietary practices to eat foods that have a lower amount of inflammatory molecules that might help reduce overall inflammation in the brain and body.

The second arm is the N-acetyl cysteine group to provide patients with a natural supplement that support antioxidants in the body.

Masking: None (Open Label)
Masking Description:
This is an Open Label study.
Primary Purpose: Diagnostic
Chronic Traumatic Brain Injury
  • Other: Anti-inflammatory Diet
    Integrative diet that reduces saturated fats and carbohydrates and emphasizes proteins and omega-3 fats that help reduce inflammation and oxidative damage.
  • Dietary Supplement: N-acetyl Cysteine
    Intravenous and Oral n-acetyl cysteine
  • Active Comparator: Dietary (AID) Cohort
    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.
    Intervention: Other: Anti-inflammatory Diet
  • Active Comparator: Intravenous/Oral NAC Cohort
    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.
    Intervention: Dietary Supplement: N-acetyl Cysteine
  • No Intervention: Control Cohort
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Same as current
February 11, 2021
February 10, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals with a history of TBI and complaints of persistent symptoms including cognitive impairment, emotional disturbances, headache, or other symptoms associated with TBI.
  • Age 18-80 years old
  • Patients had no other pre-existing history (i.e. prior to the TBI) of significant medical, neurological, or psychological disorders such as schizophrenia or active substance abuse.
  • Minor, stable health problems that should have no substantial effect on cerebral blood flow will be allowed (i.e. controlled hypertension, medication controlled diabetes).
  • Able to give informed consent and willing to complete the study at Thomas Jefferson University, Marcus Institute of Integrative Medicine Centers in Pennsylvania.
  • Patients will be allowed to be taking medications or supplements at the initial intake, but they must be on a stable dose regimen for at least 1 month.
  • Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the period of pilot study. In addition, male subjects who have a partner of childbearing age should practice effective contraception.

Exclusion Criteria:

  • Previous brain surgery.
  • Score on Mini-Mental Status examination of 25 or lower.
  • Intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality affecting the target area).
  • Pregnant or lactating women.
  • Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
  • Any pre-existing medical conditions that may interfere with cerebral function.
  • Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight > 350 pounds)
  • Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.
  • Patients taking medications that might interact with the NAC involved in this study will be evaluated on a case by case basis by the PI or study physician.
  • Patients that have a history of uncontrolled diabetes, asthma, gastroesophageal reflex disease, or thyroid conditions.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact: Nancy Wintering, LCSW 2155033423 nancy.wintering@jefferson.edu
United States
 
 
NCT03241732
17D.138
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Thomas Jefferson University
Thomas Jefferson University
Not Provided
Principal Investigator: Andrew B. Newberg, MD Thomas Jefferson University
Thomas Jefferson University
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP