An interventional study of BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation in Disorder of Consciousness, Vegetative State and Minimally Conscious State, sponsored by Casa Colina Hospital and Centers for Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Casa Colina Hospital and Centers for Healthcare · Not applicable, Interventional, and Basic science
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.
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.
138 studies on the registry are indexed under Coma; 35 are open to participants now.
This study's enrollment of 16 is below the median of 85 across 77 interventional studies indexed under Coma.
Browse Coma studies →Casa Colina Hospital and Centers for Healthcare is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
Compared within Coma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Consciousness Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Chronic status:
Exclusion Criteria:
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.
Device: BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation
Administration of 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, over the "temporal window" in order to minimize bone absorption and refraction. Accurate aiming will be ensured employing the BrainSight neuronavigation device, customized for tracking our LIFUP transducer (total \~10 min). Once satisfactory aiming is achieved, the LIFUP exposure will be initiated employing the settings described previously (which meet the FDA safety limits: ISPPA \<= 190W/cm2, ISPTA \<= 0.72W/cm2). Accurate aiming will be monitored in real-time throughout exposure using the Brain Sight Neuronavigation interface.
Coma Recovery Scale-Revised
Change in maximum total and subscale scores.
Time frame: Coma recovery scale-revised is completed at enrollment and twice a day on Day 1-10, except for Day 4. Maximum score is 23 with a minimum of 0. Higher scores mean better outcome.
Electroencephalography
Change in fast to slow frequency power spectrum density and in P3b amplitude.
Time frame: The EEG will be conducted at Day 3, 4, 7 and 10 of the study.
Positron Emission Tomography
Assess change in local standard uptake value (SUV) and global SUV.
Time frame: This will be conducted on Day 4.
Polysomnography
Change in nightly average density of sleep-spindles and sleep structure.
Time frame: This will be conducted Day 1-10 of the study.
Plan to share: No
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Casa Colina Hospital and Centers for Healthcare