The Use of LIFUP in Chronic Disorders of Consciousness (NCT04921683) | Clinical Trial Compass
CompletedNot Applicable
The Use of LIFUP in Chronic Disorders of Consciousness
United States16 participantsStarted 2021-06-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Diagnosis of VS or MCS based on the CRS-R .
✓. Chronic status:
✓. 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.
What they're measuring
1
Coma Recovery Scale-Revised
Timeframe: 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.
2
Electroencephalography
Timeframe: The EEG will be conducted at Day 3, 4, 7 and 10 of the study.
3
Positron Emission Tomography
Timeframe: This will be conducted on Day 4.
4
Polysomnography
Timeframe: This will be conducted Day 1-10 of the study.
Trial details
NCT IDNCT04921683
SponsorCasa Colina Hospital and Centers for Healthcare
. 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.