GASTRIC ACTIVITY ANALYSIS SYSTEM / DEVICE / METHOD
A method including monitoring a patient's gastric activity by obtaining data based on spectral gastric activity with an electrode array over a predetermined test period, concurrently obtaining patient symptom information for a predetermined set of symptoms during at least a portion of the test period, determining a normalized gastric activity amplitude over at least a portion of the test period from the measured gastric activity data, and correlating over at least a portion of the test period said patient symptom information with said normalized gastric activity amplitude and determining a measure of said correlation and at least one of: treating for a gut-brain axis disorder if the measure indicates a correlation is absent, optionally by not satisfying a predetermined correlation threshold or treating for gastric dysfunction if the measure of said correlation indicates a correlation exists, optionally by satisfying a predetermined correlation threshold.
1 .- 47 . (canceled)
48 . A method for monitoring gastric activity with an electrode array patch disposed over a skin surface of a patient to determine a gastrointestinal phenotype, the method comprising:
measuring spectral gastric activity data of the patient with the electrode array over a predetermined test period;
concurrently receiving patient symptom information for a predetermined set of symptoms over the predetermined test period;
determining a gastric activity amplitude over at least a portion of the test period from the measured gastric activity data; and
correlating the patient symptom information with the gastric activity amplitude;
determining a measure of correlation; and
determining a gastrointestinal phenotype based at least in part on the measure of correlation.
49 . The method of claim 48 , wherein the gastrointestinal phenotype comprises a sensorimotor phenotype.
50 . The method of claim 49 , wherein the sensorimotor phenotype is associated with postprandial distress syndrome therapies.
51 . The method of claim 49 , wherein the measure of correlation is indicative of substantial synchronization between a severity of patient symptom information and the gastric activity amplitude.
52 . The method of claim 48 , wherein the gastrointestinal phenotype comprises a post-gastric phenotype.
53 . The method of claim 52 , wherein the post-gastric phenotype is associated with small bowel or biliary therapies.
54 . The method of claim 52 , wherein the measure of correlation is indicative of an increase in severity of patient symptom information following a decrease in the gastric activity amplitude.
55 . The method of claim 48 , wherein the gastrointestinal phenotype comprises an activity-alleviated phenotype.
56 . The method of claim 55 , wherein the activity-alleviated phenotype is associated with neuromodulation therapies.
57 . The method of claim 55 , wherein the measure of correlation is indicative of a decrease in severity of patient symptom information preceding an increase in the gastric activity amplitude.
58 . The method of claim 48 , wherein the gastrointestinal phenotype comprises a continuous phenotype.
59 . The method of claim 58 , wherein the continuous phenotype is associated with gut-brain disorder or epigastric pain syndrome therapies.
60 . The method of claim 58 , wherein a severity of patient symptom information is consistent throughout the predetermined test period and the measure of correlation is indicative of a lack of synchronization between the symptom severity and the gastric activity amplitude.
61 . The method of claim 48 , further comprising providing the patient with a standardized meal at a predetermined time during the predetermined test period.
62 . The method of claim 48 , wherein measuring gastric activity data with an electrode array further includes generating spatial information associated with gastric activity of the patient.
63 . The method of claim 48 , wherein the patient symptom information is received predetermined intervals during the test period.
64 . The method of claim 48 , wherein the patient symptom information includes a symptom severity metric.
65 . The method as claimed in claim 48 , wherein the predetermined set of patient symptoms comprise:
a) nausea
b) bloating
c) upper gut pain
d) heartburn
e) stomach burn, or
f) excessive fullness.
66 . The method as claimed in claim 48 , further comprising determining a measure of temporal association and determining the gastrointestinal phenotype of the patient based on the measure of correlation and the measure of temporal association.
67 . A system for monitoring gastric activity of a patient to determine a gastrointestinal phenotype, the system comprising:
an electrode array patch having a plurality of electrodes configured to measure spectral gastric activity data of the patient over a predetermined test period; and
a processor configured to:
receive the measured spectral gastric activity data;
concurrently receive patient symptom information for a predetermined set of symptoms over the predetermined test period;
determine a gastric activity amplitude over at least a portion of the test period from the measured gastric activity data; and
correlate the patient symptom information with the gastric activity amplitude;
determine a measure of correlation;
determine a gastrointestinal phenotype based at least in part on the measure of correlation; and
generate a report comprising at least the determined gastrointestinal phenotype.
68 . The system of claim 67 , further comprising a connector device coupled to the electrode array patch.
69 . The system of claim 67 , further comprising a patient logging device for patient symptom information input.
70 . The system of claim 67 , further comprising a display for displaying the generated report in a digital medium.
71 . The system of claim 67 , wherein the report comprises a physical medium.
72 . The system of claim 67 , wherein the gastrointestinal phenotype comprises a sensorimotor phenotype.
73 . The system of claim 72 , wherein the sensorimotor phenotype is associated with postprandial distress syndrome therapies.
74 . The system of claim 72 , wherein the measure of correlation is indicative of substantial synchronization between a severity of patient symptom information and the gastric activity amplitude.
75 . The system of claim 67 , wherein the gastrointestinal phenotype comprises a post-gastric phenotype.
76 . The system of claim 75 , wherein the post-gastric phenotype is associated with small bowel or biliary therapies.
77 . The system of claim 75 , wherein the measure of correlation is indicative of an increase in severity of patient symptom information following a decrease in the gastric activity amplitude.
78 . The system of claim 67 , wherein the gastrointestinal phenotype comprises an activity-alleviated phenotype.
79 . The system of claim 78 , wherein the activity-alleviated phenotype is associated with neuromodulation therapies.
80 . The system of claim 78 , wherein the measure of correlation is indicative of a decrease in severity of patient symptom information preceding an increase in the gastric activity amplitude.
81 . The system of claim 67 , wherein the gastrointestinal phenotype comprises a continuous phenotype.
82 . The system of claim 81 , wherein the continuous phenotype is associated with gut-brain disorder or epigastric pain syndrome therapies.
83 . The system of claim 81 , wherein a severity of patient symptom information is consistent throughout the predetermined test period and the measure of correlation is indicative of a lack of synchronization between the symptom severity and the gastric activity amplitude.
84 . The system of claim 67 , wherein the spectral gastric activity data further includes spatial information associated with gastric activity of the patient.
85 . The system of claim 67 , wherein the patient symptom information is received at predetermined intervals during the test period.
86 . The system of claim 67 , wherein the patient symptom information includes a symptom severity metric.
87 . The system of claim 67 , wherein the predetermined set of patient symptoms comprise:
a) nausea
b) bloating
c) upper gut pain
d) heartburn
e) stomach burn, or
f) excessive fullness.
88 . The system of claim 67 , wherein the processor is further configured to determine a measure of temporal association.
89 . The system of claim 88 , wherein the processor is further configured to determine the gastrointestinal phenotype of the patient based on the measure of correlation and the measure of temporal association.