The Use of LIFUP in Chronic Disorders of Consciousness
Disorder of Consciousness, Vegetative State, Minimally Conscious State
About this trial
This is an interventional basic science trial for Disorder of Consciousness
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Casa Colina Hospital
Arms of the Study
Arm 1
Experimental
Treatment LIFUP
LIFUP will be performed at the bedside using frameless stereotaxy. Specifically, the LIFUP transducer will be fit to the patient's head employing adjustable straps, and will be positioned over the patient's left temporal bone to minimize bone absorption and refraction. Accurate aiming will be ensured using the Brain Sight neuronavigation device, customized for tracking our LIFUP transducer. Following LIFUP, the patient will undergo a second EEG session, except for the EEG cap being fit to the patient's head prior to the LIFUP session so that, as soon as LIFUP administration is complete, the EEG paradigm can be promptly administered. The patient will then be allowed to rest (~1h).The patient will then be administered a second dose of tracer in order to undergo a second PET measurement. Finally, at the end-of-day, the clinical coordinator will collect an Adverse Event Questionnaire and will fit the PSG device for night monitoring.