150 Participants Needed

PET-MRI for Traumatic Brain Injury

(PET-MRIcTBI Trial)

Recruiting at 1 trial location
NW
Overseen ByNancy Wintering, LCSW
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Thomas Jefferson University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

AB

Andrew B. Newberg, MD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

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.
See 4 more

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.
See 7 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
4Treatment groups
Active Control
Group I: Neuro Emotive Technique (NET)Active Control1 Intervention
Group II: Intravenous/Oral NAC CohortActive Control1 Intervention
Group III: Dietary (AID) CohortActive Control1 Intervention
Group IV: Control CohortActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials
475
Recruited
189,000+
Unbiased ResultsWe believe in providing patients with all the options.
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