Trial Outcomes & Findings for Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis (NCT NCT05362578)

Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis

The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD) symptom daily score was generated by summing the scores on each of five symptom items (nausea, early satiety, postprandial fullness, upper abdominal pain, and number of vomiting episodes), each ranging from 0 (none) to 4 (very severe) and then dividing by 5, that is the number of items within the gastroparesis related symptom score. The minimum score was 0 and the maximum score was 4. Higher numbers indicated greater symptom impact. Scores will be compared from day 0 to day 84.

A 36-question assessment to score overall quality of life. The SF-36 consisted of eight health domains with questions, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0-100 scale on the assumption that each question carried equal weight. The scores from those domains were then averaged together for a final score within a full range of 0-100, with higher values indicating greater function and 100 representing the highest level of functioning possible.

A water-satiety drink test was performed during which the participant was asked to drink at a speed of 60ml/min until reaching the maximum tolerable volume (MTV). Results reflect the maximum tolerable volume of the water-satiety drinking test.

EGG was performed twice at both the baseline and at the 8-week visit. One 30-minute EGG was performed prior to the gastric accommodation test, and one 30-minute EGG was performed after the nutrient drink test. The goal was to measure gastric slow waves, which act as an indirect measure of gastric transit time. The difference in slow waves was compared pre- and post- gastric accommodation. Slow waves were also compared between visit 1 and visit 2. The percentage of normal gastric slow waves was previously used to predict delayed gastric emptying in participants with gastroparesis. Higher percentage of normal slow waves suggests an improvement in gastric emptying.

ECG recorded while sitting 30 minutes b/f drinking (fasting) and 30 minutes after drinking water. Same procedure used at first visit (pretreatment) and second visit (post-treatment week 8). Goal was to measure autonomic function by calculating heart rate variability (HRV). Artifacts from recoded ECG signal were removed and R-peaks were detected. Time interval b/w successive R-peaks (RR interval) was calculated to generate HRV signal, which was used to calculate HRV parameters. Power w/i 0.15-0.40 Hz frequency band was defined as high-frequency (HF) power, while power w/i 0.04-0.15 Hz band was defined as low-frequency (LF) power. Normalized high-frequency power (HFn) was calculated as HFn = HF/HF+LF. HFn showed vagal/parasympathetic activity, with higher values indicating more active parasympathetic response and more responsive autonomic system. Pre-drinking (fasting) value of each HRV parameter at baseline (week 0) was compared to week 8 (after treatment) for both TEA and Sham groups.

The ECG was recorded in sitting position for 30 minutes before drinking (under fasting state) and 30 minutes after drinking water in sitting position. The same procedure was followed during first visit (pretreatment) and during the second visit (post-treatment week 8). The goal is to measure autonomic function via calculating the heart rate variability (HRV). The artifacts from the recoded ECG signal were removed and R-peaks were detected. The time interval between successive R peaks (the RR interval) was calculated to generate the HRV signal, which was used to calculate the HRV parameters. Sympathetic Index (SI) is HRV marker of Sympathetic Nervous system activity, with lower number meaning lower sympathetic activity and high numbers indicating greater sympathetic activity. The pre-drinking (fasting) value of each HRV parameter at baseline (week 0) was compared to that at week 8 (after treatment) for both TEA and Sham groups.

The ECG was recorded in sitting position for 30 minutes before drinking (under fasting state) and 30 minutes after drinking water in sitting position. The same procedure was followed during first visit (pretreatment) and during the second visit (post-treatment week 8). The goal was to measure autonomic function via calculating the heart rate variability (HRV). The artifacts from the recoded ECG signal were removed and R-peaks were detected. The time interval between successive R peaks (the RR interval) was calculated to generate the HRV signal, which was used to calculate the HRV parameters. The LFn/HFn ratio reflects autonomic balance, with higher value indicating the autonomic balance shifts towards the sympathetic, which a lower value indicates that the autonomic balance shifts towards the parasympathetic. The pre-drinking (fasting) value of each HRV parameter at baseline (week 0) was compared to that at week 8 (after treatment) for both TEA and Sham groups.

A 36 question assessment to score overall quality of life. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.