The Use of LIFUP in Chronic Disorders of Consciousness

Completed · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04921683

Run by

Casa Colina Hospital and Centers for Healthcare

People needed

16

Starts

2021-06-21

Expected to finish

2023-04-14

Last updated by the study team

2023-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of VS or MCS based on the CRS-R .
• Chronic status:
• 3 months post-injury for non-traumatic etiologies
• 12 months post-injury for traumatic etiology
• 18 years of age or older.
• 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 may not qualify if…

• History of neurological disorder (other than the brain injury).
• Unsuitability to undergo Magnetic Resonance (MR) assessment (e.g., non-MR compatible implants).
• 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).
• Manifest continuous spontaneous movement (which would prevent imaging)
• Participation in another concurrent clinical trial.
• 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.
• Dependence on ventilator.

Where it is running

• Casa Colina Hospital — Pomona, California, United States

Full record on ClinicalTrials.gov

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