Thalamic Low Intensity Focused Ultrasound in Acute Brain Injury



Status:Recruiting
Conditions:Hospital, Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:July 2015
End Date:April 2019
Contact:Martin M Monti, Prof
Email:monti@ucla.edu
Phone:310-825-8546

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

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.

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 sessions (one occurring after deep sedation is stopped and
the second one occurring just before discharge). The proposed experiment will involve
behavioral (i.e., CRS-R) and paramedical (i.e., MRI/fMRI and EEG) measurements just before
and after each of the two LIFUP sessions (i.e., 5 non-consecutive minutes of stimulation in
each session) in a small sample of patients (up to 15) in order to evaluate the feasibility
of a full scale clinical trial. Outcome measures (i.e., GOSE and CRS-R) will be administered
at discharge, 6 months and one year after injury. The duration of participation in the study
will be a year.

In terms of impact, we think this project would have a number of immediate consequences. (i)
A successful pilot study and any indication that this approach might have the hypothesized
effect would place us in a unique position to initiate a fully-fledged double-blind clinical
trial in a large cohort of patients.

(ii) From a purely scientific point of view, by virtue of testing what is today the most
prominent physiological hypothesis concerning loss and recovery of consciousness after severe
brain injury, this project has a direct repercussion on our understanding of the mechanisms
underlying these conditions. (iii) From a clinical and patient management point of view the
present project is the first necessary step towards opening a completely new avenue for
care-taking in patients suffering from this devastating condition for which there is no
intervention. In particular, if this project were successful in the long run (e.g., after a
double-blind full clinical trial), it could make widely available a non-invasive protocol
which could substitute the currently highly invasive (and therefore not widely available, and
high risk) only intervention available.

Inclusion Criteria:

- a Glasgow Coma Score < 9 (at the time of injury)

- an abnormal CT

- prolonged loss of consciousness (>24h)

Exclusion Criteria:

* deep sedation
We found this trial at
1
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Los Angeles, California 90095
310-825-4321
Phone: 310-825-8546
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