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Trial record 24 of 317 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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Traumatic Brain Injury Other: Anti-inflammatory Diet Dietary Supplement: N-acetyl Cysteine Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Official Title: Defining Neurobiological Signatures for Chronic Traumatic Brain Injury Using PET-MRI
Actual Study Start Date : June 7, 2017
Estimated Primary Completion Date : February 10, 2020
Estimated Study Completion Date : February 11, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
Dietary Supplement: N-acetyl Cysteine
Intravenous and Oral 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.



Primary Outcome Measures :
  1. Fluorodeoxyglucose positron emission tomography (FDG-PET). [ Time Frame: Baseline in all study arms. ]
    To measure inflammation and oxidative damage in the brain.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241732


Contacts
Contact: Nancy Wintering, LCSW 2155033423 nancy.wintering@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University, Marcus Institute of Integrative Health Centers Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Nancy Wintering, LCSW    215-503-3423    nancy.wintering@jefferson.edu   
Principal Investigator: Andrew B Newberg, MD         
Thomas Jefferson University, Marcus Institute of Integrative Health Centers Recruiting
Villanova, Pennsylvania, United States, 19085
Contact: Nancy Wintering, LCSW    215-503-3423    nancy.wintering@jefferson.edu   
Principal Investigator: Andrew B Newberg, MD         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Andrew B. Newberg, MD Thomas Jefferson University
  Study Documents (Full-Text)

Documents provided by Thomas Jefferson University:

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03241732     History of Changes
Other Study ID Numbers: 17D.138
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Jefferson University:
Traumatic Brain Injury
Brain Trauma
TBI
N-acetyl cysteine
Concussion
NAC
Integrative Medicine
EEG
electroencephalogram
Functional magnetic resonance imaging or functional MRI
fMRI
PET
Positron emission tomography
MRI
magnetic resonance imaging

Additional relevant MeSH terms:
Brain Injuries, Traumatic
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Anti-Inflammatory Agents
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes