Gastrointestinal diagnostic aid
The present invention discloses systems and methods for mapping gastric activity with an electrode array patch disposed over an abdomen skin surface of a patient. A method may include measuring electrical signals associated with gastric activity of the patient with the electrode array patch over a predetermined time period and concurrently receiving patient symptom information, determining one or more normalized biometrics from the measured electrical signals, correlating the one or more normalized biometrics and the patient symptom information, determining a measure of correlation, determining a measure of temporal association, and determining a gastrointestinal phenotype of the patient based at least in part on the measure of correlation and the measure of temporal association. The present invention advantageously enables mapping of gut motility patterns at high spatial resolution for the identification of gastric disorders and provides biomarkers of pathophysiology which include correlations with symptom severity profiles.
1. A system for mapping gastric activity of a patient, the system comprising:
an electrode array patch having a plurality of electrodes configured to measure electrical signals associated with gastric activity of the patient; and
a processor configured to:
receive the measured electrical signals from the electrode array patch over a continuous time period of at least 2 hours;
concurrently receive patient symptom information over the entire continuous time period with the measured electrical signals;
determine one or more normalized biometrics over at least a portion of the continuous time period from the measured electrical signals;
correlating the one or more normalized biometrics and a symptom burden from the patient symptom information over the entire continuous time period;
determine a measure of correlation over the continuous time period;
determine a measure of temporal association in at least one time interval over the continuous time period between a gastric amplitude and at least one patient symptom information; and
determine a gastrointestinal phenotype of the patient based at least in part on the measure of correlation and the measure of temporal association; and
generate a report comprising at least the determination of the gastrointestinal phenotype.
2. The system of claim 1 , further comprising a connector device coupled to the electrode array patch and wirelessly coupled to the processor.
3. The system of claim 2 , wherein the connector device is configured for transmission of the measured electrical signals to the processor.
4. The system of claim 1 , further comprising a patient mobile device for patient symptom information input, wherein the patient mobile device is in wireless communication with the processor for transmission of patient symptom information.
5. The system of claim 1 , further comprising a display for displaying the generated report.
6. The system of claim 1 , wherein the gastrointestinal phenotype comprises at least one of a normal Body Surface Gastric Mapping (BSGM) phenotype, a delayed onset phenotype, a low stability and/or low amplitude phenotype, or a high amplitude phenotype.
7. The system of claim 6 , wherein the normal BSGM phenotype is associated with no measure of correlation and the measure of temporal association between −0.25 and +0.25 over a predetermined pre-prandial and post-prandial time period.
8. The system of claim 6 , wherein the delayed onset phenotype is associated with the measure of temporal association less than −0.25 over a predetermined pre-prandial and post-prandial time period.
9. The system of claim 6 , wherein the low stability and/or low amplitude phenotype is associated with the measure of temporal association between −0.25 and +0.25 over a predetermined pre-prandial and post-prandial time period.
10. The system of claim 6 , wherein the low stability and/or low amplitude phenotype is associated with neuromuscular disorders.
11. The system of claim 10 , wherein the neuromuscular disorder comprises at least one of gastric dysrhythmias, interstitial cell of Cajal disorders, antral hypomotility, smooth muscle disorders, or gastroparesis.
12. The system of claim 6 , wherein the normal BSGM phenotype is associated with a gut-brain axis disorder.
13. The system of claim 12 , wherein the gut-brain axis disorder comprises at least one of irritable bowel syndrome, reflux hypersensitivity, or functional dyspepsia.
14. The system of claim 6 , wherein the delayed onset phenotype is associated with gastroparesis.
15. The system of claim 6 , wherein the gastrointestinal phenotype comprises at least one of a sensorimotor phenotype, a neuromuscular phenotype, a post-gastric phenotype, an activity-alleviated phenotype, or a continuous phenotype.
16. The system of claim 1 , wherein the one or more normalized biometrics comprises at least one of a principal gastric frequency (PGF), a body mass index (BMI)-adjusted amplitude, Gastric Alimetry Rhythm Index (GA-RI), fed-fasted amplitude ratio (ff-AR), and meal response ratio.
17. The system of claim 1 , wherein the measured electrical signals and patient symptom information are received over a pre-prandial and post-prandial time period.
18. The system of claim of claim 1 , wherein the patient symptom information comprises nausea, vomiting, bloating, upper gut pain, heartburn, stomach burn, or excessive fullness.
19. The system of claim of claim 18 , wherein the symptom burden comprises a scaled rating or symptom curve.
20. The system of claim of claim 1 , wherein determining a measure of temporal association comprises calculating a temporal correlation coefficient.
21. A system for mapping gastric activity of a patient, the system comprising:
an electrode array patch having a plurality of electrodes configured to measure electrical signals associated with gastric activity of the patient; and
a processor configured to:
receive the measured electrical signals from the electrode array patch over a continuous time period of at least 2 hours;
concurrently receive patient symptom information over the entire continuous time period with the measured electrical signals;
determine one or more normalized biometrics over at least a portion of the continuous time period from the measured electrical signals;
correlating the one or more normalized biometrics and a symptom burden from the patient symptom information;
determine a measure of correlation over the continuous time period;
determine a measure of temporal association in at least one time interval over the continuous time period between one or more normalized biometrics and at least two symptoms from the patient symptom information; and
determine a gastrointestinal phenotype of the patient based at least in part on the measure of correlation and the measure of temporal association, wherein the phenotype comprises at least one of a sensorimotor phenotype, a neuromuscular phenotype, a post-gastric phenotype, an activity-alleviated phenotype, or a continuous phenotype; and
generate a report comprising at least the determination of the gastrointestinal phenotype.
22. The system of claim of claim 21 , wherein the patient symptom information comprises nausea, vomiting, bloating, upper gut pain, heartburn, stomach burn, or excessive fullness.
23. The system of claim of claim 22 , wherein the symptom burden comprises a scaled rating or symptom curve.
24. The system of claim of claim 21 , wherein the one or more normalized biometrics comprises at least one of a principal gastric frequency (PGF), a body mass index (BMI)-adjusted amplitude, Gastric Alimetry Rhythm Index (GA-RI), fed-fasted amplitude ratio (ff-AR), and meal response ratio.
25. The system of claim of claim 21 , wherein determining a measure of temporal association comprises calculating a temporal correlation coefficient.