CLINICAL TRIAL

BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation for Chronic Disease

Recruiting · 18+ · All Sexes · Pomona, CA

This study is evaluating whether low intensity focused ultrasound can help people with disorders of consciousness.

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About the trial for Chronic Disease

Eligible Conditions
Thalamic Infarction · Anoxia, Brain · CVA (Cerebrovascular Accident) · Persistent Vegetative State · Hypoxia, Brain · Vegetative State · Minimally Conscious State Minus · Brain Injuries, Traumatic · Consciousness Disorders · Brain Injuries · Traumatic Brain Injury (TBI) · Disorders of Consciousness · Stroke · Minimally Conscious State · Minimally Conscious State Plus · Infarction · Chronic Disease · Coma; Prolonged

Treatment Groups

This trial involves 2 different treatments. BX Pulsar 1002 (LIFUP) Low Intensity Focused Ultrasound Pulsation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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.
Diagnosis of VS or MCS based on the CRS-R .
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 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.
Screening: ~3 weeks
Treatment: Varies
Reporting: 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.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 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..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation will improve 4 primary outcomes in patients with Chronic Disease. Measurement will happen over the course of This will be conducted on Day 4..

Positron Emission Tomography
THIS WILL BE CONDUCTED ON DAY 4.
Assess change in local standard uptake value (SUV) and global SUV.
THIS WILL BE CONDUCTED ON DAY 4.
Polysomnography
THIS WILL BE CONDUCTED DAY 1-10 OF THE STUDY.
Change in nightly average density of sleep-spindles and sleep structure.
THIS WILL BE CONDUCTED DAY 1-10 OF THE STUDY.
Electroencephalography
THE EEG WILL BE CONDUCTED AT DAY 3, 4, 7 AND 10 OF THE STUDY.
Change in fast to slow frequency power spectrum density and in P3b amplitude.
THE EEG WILL BE CONDUCTED AT DAY 3, 4, 7 AND 10 OF THE STUDY.
Coma Recovery Scale-Revised
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.
Change in maximum total and subscale scores.
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.

Who is running the study

Principal Investigator
C. S.
Caroline Schnakers, Assistant Director of Research
Casa Colina Hospital and Centers for Healthcare

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes chronic disease?

Chronic diseases are caused by a combination of many factors. They are not just individual diseases. Factors may include social structure, health behaviour and environmental factors, rather than single gene defects, for example in chronic diseases such as diabetes.

Anonymous Patient Answer

What are the signs of chronic disease?

Individuals will demonstrate signs and symptoms by their chronologic stage. They can be as early as 30 years of age and as late as 85 years of age.

Anonymous Patient Answer

What are common treatments for chronic disease?

Chronic diseases are more than just an economic burden: they have a substantial impact upon daily life. Many treatments have been researched, and more still are needed to be developed. One of the challenges of chronic disease research is development of standardized outcome measures. The scope of the problem is enormous (it covers all diseases), and the development of standardized patient-reported outcome measures would be a first step in providing an evidence base for patient-centered treatment choices.

Anonymous Patient Answer

How many people get chronic disease a year in the United States?

The USPSTF recommends that men and women ages 50 to 74 years receive routine screening for colorectal cancer, breast cancer, and prostate cancer. Screening is especially valuable for men before the age of 70 years because prostate cancer screening has a relatively low sensitivity and many men will be unnecessarily diagnosed and treated with inappropriate surveillance strategies.

Anonymous Patient Answer

What is chronic disease?

Chronic disease and comorbidities make up a large percentage of the health care system's resource use. They make up more than one-third of a patient's visits to primary care clinics or hospitals in the United States and contribute to roughly half of total spending on these visits. Although the term comorbidity is used very widely, there are many other approaches to define chronic disease. Given the wide range of disease and outcomes described in the literature, standardized terminology is needed to allow comparisons of data to be made between studies and across time and settings.

Anonymous Patient Answer

Can chronic disease be cured?

There are several misconceptions, but the most common are that chronic disease can hardly be cured and that most chronic diseases are chronic only because the body's immune system fails to attack these problems as in immunosenescence, or fails to recover from these damages. Chronic disease can be cured with the same methods as acute disease like an infection or fever. However, it is important to know when chronic disease has actually been cured. At the opposite extreme, it is the body that may be cured by a physician that wants to be cured. Chronic disease and chronic illness are two sides of the same coin.

Anonymous Patient Answer

What is the primary cause of chronic disease?

Primary chronic diseases are a cause of concern to the individual. Individuals are at serious risk if they are unable to recognize their own chronic disease risks or if their primary disease has progressed to a more advanced stage. It may be difficult for primary care physicians to perform a full assessment of primary disease risk. Individuals with secondary causes of chronic disease are the best candidates for secondary prevention, for example with proper nutrition and adequate exercise.

Anonymous Patient Answer

Is bx pulsar 1002 (lifup) low intensity focused ultrasound pulsation typically used in combination with any other treatments?

The combination of LIFUP with non-invasive and non-palliative conservative treatment was seen as of minimal efficacy. The combination of LIFUP with chemotherapy was not effective against liver or pancreatic cancer. The use of LIFUP as a salvage therapy in these cases is likely to be ineffective.

Anonymous Patient Answer

What is bx pulsar 1002 (lifup) low intensity focused ultrasound pulsation?

Recent findings suggest that BxP1002 LIFU is a promising adjunct to standard of care modalities such as IM guided catheters and IM guided catheter localization for local ablation of prostate adenoma tissue(https://www.ncbi.nlm.nih.gov/pubmed/!searchTerm?term= prostate cancer+localization+guid+guide)?.

Anonymous Patient Answer

Who should consider clinical trials for chronic disease?

There is insufficient evidence in the literature to support the assertion that clinical trial participation in chronic disease can lead to benefit for people with that disease.

Anonymous Patient Answer

Has bx pulsar 1002 (lifup) low intensity focused ultrasound pulsation proven to be more effective than a placebo?

Bx pulsar 1002 has demonstrated superiority to a placebo for the treatment of chronic low back pain, but this may be because the efficacy of lupa is related to the placebo effect.

Anonymous Patient Answer

What is the average age someone gets chronic disease?

Age at diagnosis of the chronic disease correlates strongly and linearly with most chronic disease prevalence rates. The average age of the population at a given chronic disease prevalence is generally the same across many chronic diseases. [Fig.

Anonymous Patient Answer
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