Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Martin Monti (ucla)

Description

Summary

When patients survive a severe brain injury but fail to fully recover, they often enter a Disorder of Consciousness (DoC) --that is, a set of related conditions of decreased awareness and arousal including the Vegetative State (VS) and the Minimally Conscious State (MCS). When these conditions become chronic, there are no approved treatments to help bolster any further recovery. In prior work, we have shown the clinical feasibility and potential of Low Intensity Focused Ultrasound Pulsation (LIFUP) as a remarkably safe form of non-invasive brain stimulation in these conditions.

Official Title

Biomarkers of Thalamic LIFUP in Chronic Disorders of Consciousness

Details

In the present study, we propose taking the "next step" to assess whether LIFUP can affect objective and validated markers of DoC patient impairment (in the direction of lesser impairment). Specifically, patients will be admitted at Casa Colina Hospital for a 10-day (in-patient) protocol, and two follow-up sessions, conducted remotely (e.g., over the phone) at 7 and 30-days post-discharge. The full length of the study is 40 days from admission. Over the admission period, patients will undergo multiple measurements of validated biomarkers, including behavioral testing, brain metabolism (using Positron Emission Tomography), and electroencephalography, before and after one session of LIFUP to thalamus.

Keywords

Disorder of Consciousness Vegetative State Minimally Conscious State Minimally Conscious State Plus Minimally Conscious State Minus Traumatic Brain Injury CVA (Cerebrovascular Accident) Anoxia, Brain Thalamic Infarction Coma; Prolonged Brain Injuries Brain Injuries, Traumatic Stroke Consciousness Disorders Persistent Vegetative State Hypoxia, Brain Infarction Chronic Disease BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Diagnosis of VS or MCS based on the CRS-R .
  2. Chronic status:
  3. 3 months post-injury for non-traumatic etiologies
  4. 12 months post-injury for traumatic etiology
  5. 18 years of age or older.
  6. If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and the patient will be willing to remain on a stable regimen during the protocol.

You CAN'T join if...

  1. History of neurological disorder (other than the brain injury).
  2. Unsuitability to undergo Magnetic Resonance (MR) assessment (e.g., non-MR compatible implants).
  3. Unsuitability to undergo LIFUP neuromodulation (e.g., presence of non-bone implant or absence of bone under the expected positioning of the device by the left temporal bone window).
  4. Manifest continuous spontaneous movement (which would prevent imaging)
  5. Participation in another concurrent clinical trial.
  6. Having undergone PET, CT, or other exam involving the use of ionizing radiation in the 12 months prior to the date of scheduled admission to Casa Colina.
  7. Dependence on ventilator.

Location

  • Casa Colina Hospital accepting new patients
    Pomona California 91709 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Casa Colina Hospital and Centers for Healthcare
ID
NCT04921683
Study Type
Interventional
Last Updated