Clinical Trial: Thalamic Low Intensity Focused Ultrasound in Acute Brain Injury

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Thalamic Low Intensity Focused Ultrasound Stimulation in Disorders of Consciousness Following Acute Severe Brain Injury

Brief Summary: Few neurological conditions are as scientifically mysterious and clinically, legally, and ethically challenging as disorders of consciousness. To date there exists no standard intervention for patients suffering from these devastating conditions. The present project is aimed at evaluating the potential of non-invasive Low Intensity Focused Ultrasound Pulsation (LIFUP) of thalamus (a key area for the consciousness network) as a neurorestorative stimulation for those patients. In this study, LIFUP will be performed during two sessions. The proposed experiment will involve behavioral and paramedical measurements just before and after each of the two LIFUP sessions in a small sample of patients (up to 15) in order to evaluate the feasibility of a full scale clinical trial. Outcome measures will be administered at discharge, 6 months and one year after injury.

Detailed Summary:

Few neurological conditions are as scientifically mysterious and clinically, legally, and ethically challenging as disorders of consciousness (DOC). Typically developed after severe brain injury, this set of related conditions includes Coma, the Vegetative State (VS) and the Minimally Conscious State (MCS). In the past 20 years, an increasing amount of research has broken many conventions about these disorders, including the once widespread belief that these patients are entirely apallic - that is, lack any kind of "higher" activity. Since then, it has been shown that a lot of brain activity, including relatively high-level cognitive processes, can remain in DOC patients. Nonetheless, to date there exists no standard intervention for patients suffering from these devastating conditions. Developing interventions for this population is extremely important first and foremost for the well-being of patients, who - today - remain completely dependent on assisted care, are often unable to participate in rehabilitative programs because of their lack of behavioral responsiveness, and thus find themselves prisoners of a condition characterized by uncertainty at the medical, legal and ethical decision-making levels. In addition, these conditions, which can last indefinitely, also place great emotional and monetary strain on families, large burdens on care-takers - often leading to increased rates of burn-out - and large financial stress on medical structures and public finances due to the large costs imposed by prolonged intensive care.

The present project is aimed at evaluating the potential of non-invasive Low Intensity Focused Ultrasound Pulsation (LIFUP) of thalamus (a key area for the consciousness network) as a neurorestorative stimulation for patients with severe brain injury.

LIFUP will be performed during two sessi
Sponsor: University of California, Los Angeles

Current Primary Outcome:

• Brain structure as assessed by Magnetic Resonance Imaging (MRI) (Session 1) [ Time Frame: around 2 weeks after injury ]
  MRI is a widely used method to assess body tissues, including the brain, in a non-invasive manner. In the context of this study, MRI will be used to assess brain structure (expected total duration 10 minutes).
• Brain function as assessed by functional Magnetic Resonance Imaging (fMRI) (Session 1) [ Time Frame: around 2 weeks after injury ]
  fMRI is a neuroimaging procedure using MRI technology that measures brain function. We will assess brain activity in response to auditory stimulation (expected total duration of 20 minutes).
• Brain structure as assessed by Magnetic Resonance Imaging (MRI) (Session 2) [ Time Frame: around 4 weeks after injury ]
  MRI is a widely used method to assess body tissues, including the brain, in a non-invasive manner. In the context of this study, MRI will be used to assess brain structure (expected total duration 10 minutes).
• Brain function as assessed by functional Magnetic Resonance Imaging (fMRI) (Session 2) [ Time Frame: around 4 weeks after injury ]
  fMRI is a neuroimaging procedure using MRI technology that measures brain function. We will assess brain activity in response to auditory stimulation (expected total duration of 20 minutes).

Original Primary Outcome:

• Magnetic Resonance Imaging (MRI) (Session 1) [ Time Frame: around 2 weeks after injury ]
  MRI is a widely used method to assess body tissues, including the brain, in a non-invasive manner. In the context of this study, MRI will be used to assess brain structure (expected total duration 10 minutes).
• functional Magnetic Resonance Imaging (fMRI) (Session 1) [ Time Frame: around 2 weeks after injury ]
  fMRI is a neuroimaging procedure using MRI technology that measures brain function. We will assess brain activity in response to auditory stimulation (expected total duration of 20 minutes).
• Magnetic Resonance Imaging (MRI) (Session 2) [ Time Frame: around 4 weeks after injury ]
  MRI is a widely used method to assess body tissues, including the brain, in a non-invasive manner. In the context of this study, MRI will be used to assess brain structure (expected total duration 10 minutes).
• functional Magnetic Resonance Imaging (fMRI) (Session 2) [ Time Frame: around 4 weeks after injury ]
  fMRI is a neuroimaging procedure using MRI technology that measures brain function. We will assess brain activity in response to auditory stimulation (expected total duration of 20 minutes).

Current Secondary Outcome:

• Coma Recovery Scale Revised (CRS-R) [ Time Frame: around 2 weeks after injury (Session 1) and around 4 weeks after injury (Session 2) ]
  The CRS-R is a standard clinical protocol used to assess a patient's level of consciousness. This test allows us to assess the level of response to sensory stimulation, ability to understand language and to communicate. This procedure is typically administered at bedside. This testing should take 25 minutes, and will consist of simple requests (such as "close your eyes" and "open your mouth").
• Electroencephalography (EEG) [ Time Frame: around 2 weeks after injury (Session 1) and around 4 weeks after injury (Session 2) ]
  EEG is a widely employed technique that measures electrical brain activity. This procedure (expected duration: 10 minutes + set-up time, up to 20 minutes) will allow us to measure electrical brain activity at rest. This procedure is entirely non-invasive.
• Glasgow Outcome Scale-Extended (GOS-E) [ Time Frame: around 4 weeks, 6 months and one year after injury ]
  The GOS-E is a standard clinical scale used to classify outcome in survivors with brain injuries. This brief assessment takes less than 10 minutes.

Original Secondary Outcome: Same as current

Information By: University of California, Los Angeles

Dates:
Date Received: August 6, 2015
Date Started: July 2015
Date Completion: April 2017
Last Updated: April 21, 2016
Last Verified: April 2016