Gastroparesis
Conditions
Brief summary
This study is investigating a new form of treatment for a digestive disorder called gastroparesis. Gastroparesis is thought to be caused by a mix of inflammation and neural dysfunction. The vagal nerve is a large nerve originating from the brain that regulates digestive function. Patients with gastroparesis have what is a called a low vagal tone which results in gastrointestinal motility problems and inflammation; therefore, investigators hypothesize that increasing vagal tone through a hand-held vagal nerve simulator will reduce inflammation and gastrointestinal motility problems in gastroparesis patients. Investigators will evaluate this hypothesis through the use of upper endoscopy testing, breath testing, and blood, stool, urine, heart rate variability, and saliva testing before and after 4 weeks of vagal nerve stimulation (VNS) treatment. There are 6 research visits Visit 1 and visit 2 may take up to 8 weeks (screening/baseline) Visit 3 and visit 4 will take 4 weeks (VNS treatment) visit 5 and 6 will take approximately 4 weeks (VNS followup/washout) Consequently, it is possible that if a patient were to be at the farthest ends of visit windows, they could potentially be in the study for approx 16 weeks. Visit 1 and 2 may be less than 8 weeks which would shorten the patient's overall involvement in the study. The treatment phase of the study will always be 4 weeks with an additional 4 week washout phase. Use of the VNS device takes 4 weeks. Endoscopy and blood work are taken before and after the treatment period.
Interventions
DEVICEVagal Nerve Stimulation
Patients will be giving themselves vagal nerve stimulation for four weeks at interval of two times a day for two minutes on each side for four weeks. The impact of the intervention on gastroparesis symptoms will be measured by upper endoscopy biopsies, blood work, autonomic function tests, survey data, stool samples, urine sample, and saliva samples before after after the four weeks of stimulation treatment.
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
15 participants planned enrollment in each arm: * Diabetic Gastroparesis * Functional Dyspepsia * Idiopathic Gastoparesis
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female. 2. Age 21-65 years old. 3. Established diagnosis of functional dyspepsia, idiopathic or diabetic gastroparesis as per AGA (American Gastroenterology Association) guidelines. 4. Patient is capable of giving informed consent and undergo upper endoscopy. 5. Patient is on stable doses of other medications for gastroparesis for preceding 4 weeks prior to enrollment (baseline measures).
Exclusion criteria
1. Surgical-related gastroparesis 2. Extrinsic myopathy or neuropathy causing gastroparesis. 3. Use of narcotic pain medications in the preceding 2 weeks of study enrollment. 4. Patients with enteric feeding tubes or requiring parenteral nutrition (Patients with g-tubes who are stable for 3 months and not using the g-tube for venting may be eligible. patient with J-tubes are not eligible. 5. Patients with severe flare requiring hospitalization. 6. Untreated significant depression or suicidal thoughts. 7. Pregnant or breast-feeding women. 8. History of gastric pacemaker implantation. 9. Patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, or gastric bypass. 10. Patients with malabsorption of enteric, pancreatic, or hepatibiliary etiology. 11. Patients with primary pulmonary disorders that affect the spirulina breath test. 12. Patients with implantable electronic devices. 13. Patients with carotid artery atherosclerosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire. | Baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days) | Investigators will send daily GCSI-DD to patients for 8 weeks. This 10 item questionnaire measures the severity of gastroparesis symptoms on a scale 0-5. 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe. Investigators hypothesize a change of more than 0.75 points. Scored were recorded daily at each time point and scores then averaged to produce an overall score (range: 0 to 5, higher scores correspond to worse symptoms). |
| Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time | Baseline and week 4 (3 hours to assess at each time point) | Investigators will measure a change in gastric emptying time before and after vagal nerve stimulation as measured in minutes. Higher number (longer times) indicate more severe gastroparesis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Serious or Treatment-emergent Adverse Event (AE) as a Measure of the Safety and Tolerability of VNS in Patients With Gastroparesis | 8 weeks | The safety and tolerability of VNS in patients with gastroparesis assessed by recording any side effects or adverse events. Number of patients reporting serious or treatment related adverse events are reported |
| Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone | Baseline, week 4, week 8 | The effect of VNS therapy on vagal tone as measured bv HRV (accounting for respiratory rate variability) using electrocardiogram (ASNAR) device. HRV is measured as an RFa value, a measure of the high-frequency heart rate (bpm\^2 per hertz). Normal RFa is 0.5 to 8.0. |
| PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain | Baseline, week 4, week 8 | The effect of VNS therapy on overall pain interference as assessed by the PROMIS (Patient Reported Outcomes Measurement Information System) pain interference questionnaire which is a 6 item questionnaire on a 5 point scale to assess the impact of pain on daily life. Scores are summed and converted to percentiles normalized for the population (normalized T-score). 50 indicates the population mean with a standard deviation of 10. The higher the T-score, the more severe the symptoms. |
| The Effect of VNS Therapy on Gastric and Small Intestine Leukocyte Infiltration. | Baseline (pre-VNS) and 4 weeks (post-VNS) | The effects of VNS therapy on gastric and small intestine leukocyte infiltration was measured as relative abundance (normalized ratio) of immune cells (identified via CD45 marker) to total live cells across tissue leukocytes from endoscopic mucosal biopsies before and after VNS, using flow cytometry. |
| Effect of VNS on Mucosal Inflammation | Baseline (pre-VNS) and 4 weeks (post-VNS) | Median fluorescence intensity (MFI) data were preprocessed for each cytokine through a sequence of averaging over duplicate wells, natural-logarithm transformation to reduce variance heterogeneity, and isolation and removal of plate effects. The effects of VNS therapy on gastric and small intestine inflammation was measured as average fold change across all tissue cytokines from endoscopic mucosal biopsies before and after VNS, using cytokine multiplex assays, which report relative levels of various cytokines as adjusted mean fluorescence intensity (MFI). |
| Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health | Baseline, week 4, week 8 | The effect of VNS therapy on overall wellbeing and health as assessed by the SF-12. Score range: 0-100, higher scores correspond to better quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Idiopathic Gastroparesis Patients with idiopathic gastroparesis and delayed gastric emptying self-administer vagal nerve stimulation for two minutes on each side twice a day in the morning and the night for four weeks (starting at visit 3 and ending at visit 5). | 15 |
| Diabetic Gastroparesis Patients with diabetic gastroparesis and delayed gastric emptying self-administer vagal nerve stimulation for two minutes on each side twice a day in the morning and the night for four weeks (starting at visit 3 and ending at visit 5). | 1 |
| Functional Dyspepsia Patients with functional dyspepsia and normal gastric emptying self-administer vagal nerve stimulation for two minutes on each side twice a day in the morning and the night for four weeks (starting at visit 3 and ending at visit 5). | 5 |
| Total | 21 |
Baseline characteristics
| Characteristic | Idiopathic Gastroparesis | Diabetic Gastroparesis | Functional Dyspepsia | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 1 Participants | 5 Participants | 21 Participants |
| Plasma cytokines | 1 Normalized mean fluoresc ent intensity STANDARD_DEVIATION 0.3 | — | — | 1 Normalized mean fluoresc ent intensity STANDARD_DEVIATION 0.3 |
| Race/Ethnicity, Customized Non-White | 3 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 12 Participants | 1 Participants | 3 Participants | 16 Participants |
| Region of Enrollment United States | 15 Participants | 1 Participants | 5 Participants | 21 Participants |
| Sex: Female, Male Female | 13 Participants | 1 Participants | 4 Participants | 18 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 1 | 0 / 6 |
| other Total, other adverse events | 1 / 17 | 0 / 1 | 0 / 6 |
| serious Total, serious adverse events | 0 / 17 | 0 / 1 | 0 / 6 |
Outcome results
Primary
Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire.
Investigators will send daily GCSI-DD to patients for 8 weeks. This 10 item questionnaire measures the severity of gastroparesis symptoms on a scale 0-5. 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe. Investigators hypothesize a change of more than 0.75 points. Scored were recorded daily at each time point and scores then averaged to produce an overall score (range: 0 to 5, higher scores correspond to worse symptoms).
Time frame: Baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days)
Population: Participants who received treatment are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idiopathic Gastroparesis | Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire. | Week 4 | 1.65 score on a scale | Standard Deviation 1.05 |
| Idiopathic Gastroparesis | Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire. | Baseline | 2.4 score on a scale | Standard Deviation 0.76 |
| Idiopathic Gastroparesis | Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire. | Week 8 | 2.0 score on a scale | Standard Deviation 1.09 |
| Diabetic Gastroparesis | Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire. | Week 4 | 1.71 score on a scale | — |
| Diabetic Gastroparesis | Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire. | Baseline | 2.68 score on a scale | — |
| Diabetic Gastroparesis | Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire. | Week 8 | 2.36 score on a scale | — |
| Functional Dyspepsia | Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire. | Baseline | 2.1 score on a scale | Standard Deviation 1.1 |
| Functional Dyspepsia | Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire. | Week 8 | 1.6 score on a scale | Standard Deviation 1.1 |
| Functional Dyspepsia | Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire. | Week 4 | 1.7 score on a scale | Standard Deviation 1 |
Primary
Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time
Investigators will measure a change in gastric emptying time before and after vagal nerve stimulation as measured in minutes. Higher number (longer times) indicate more severe gastroparesis.
Time frame: Baseline and week 4 (3 hours to assess at each time point)
Population: Participants who received treatment are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idiopathic Gastroparesis | Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time | Baseline | 155.1 minutes | Standard Deviation 40.2 |
| Idiopathic Gastroparesis | Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time | Week 4 | 129.0 minutes | Standard Deviation 37 |
| Diabetic Gastroparesis | Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time | Baseline | 140.8 minutes | — |
| Diabetic Gastroparesis | Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time | Week 4 | 120.7 minutes | — |
| Functional Dyspepsia | Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time | Baseline | 91.8 minutes | Standard Deviation 19.8 |
| Functional Dyspepsia | Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time | Week 4 | 100.8 minutes | Standard Deviation 37.7 |
Secondary
Effect of VNS on Mucosal Inflammation
Median fluorescence intensity (MFI) data were preprocessed for each cytokine through a sequence of averaging over duplicate wells, natural-logarithm transformation to reduce variance heterogeneity, and isolation and removal of plate effects. The effects of VNS therapy on gastric and small intestine inflammation was measured as average fold change across all tissue cytokines from endoscopic mucosal biopsies before and after VNS, using cytokine multiplex assays, which report relative levels of various cytokines as adjusted mean fluorescence intensity (MFI).
Time frame: Baseline (pre-VNS) and 4 weeks (post-VNS)
Population: Participants who received treatment in the Idiopathic Gastroparesis group; data were not collected in the Diabetic Gastroparesis or Functional Dyspepsia groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Gastroparesis | Effect of VNS on Mucosal Inflammation | 1 fold change of MFI | Standard Deviation 0.01 |
Secondary
Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone
The effect of VNS therapy on vagal tone as measured bv HRV (accounting for respiratory rate variability) using electrocardiogram (ASNAR) device. HRV is measured as an RFa value, a measure of the high-frequency heart rate (bpm\^2 per hertz). Normal RFa is 0.5 to 8.0.
Time frame: Baseline, week 4, week 8
Population: Participants who received treatment and with data at the respective time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idiopathic Gastroparesis | Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone | Week 4 | 20.8 RFA (bpm^2/hertz) | Standard Deviation 84 |
| Idiopathic Gastroparesis | Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone | Baseline | 10.6 RFA (bpm^2/hertz) | Standard Deviation 53.2 |
| Idiopathic Gastroparesis | Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone | Week 8 | 25.1 RFA (bpm^2/hertz) | Standard Deviation 89.7 |
| Diabetic Gastroparesis | Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone | Week 4 | 2.2 RFA (bpm^2/hertz) | — |
| Diabetic Gastroparesis | Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone | Baseline | 9.3 RFA (bpm^2/hertz) | — |
| Functional Dyspepsia | Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone | Week 4 | 11.2 RFA (bpm^2/hertz) | Standard Deviation 12.2 |
| Functional Dyspepsia | Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone | Baseline | 16.2 RFA (bpm^2/hertz) | Standard Deviation 36.7 |
| Functional Dyspepsia | Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone | Week 8 | 17.5 RFA (bpm^2/hertz) | Standard Deviation 25.5 |
Secondary
Number of Participants With Any Serious or Treatment-emergent Adverse Event (AE) as a Measure of the Safety and Tolerability of VNS in Patients With Gastroparesis
The safety and tolerability of VNS in patients with gastroparesis assessed by recording any side effects or adverse events. Number of patients reporting serious or treatment related adverse events are reported
Time frame: 8 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Idiopathic Gastroparesis | Number of Participants With Any Serious or Treatment-emergent Adverse Event (AE) as a Measure of the Safety and Tolerability of VNS in Patients With Gastroparesis | Serious AE | 0 Participants |
| Idiopathic Gastroparesis | Number of Participants With Any Serious or Treatment-emergent Adverse Event (AE) as a Measure of the Safety and Tolerability of VNS in Patients With Gastroparesis | Treatment-emergent AE | 0 Participants |
| Diabetic Gastroparesis | Number of Participants With Any Serious or Treatment-emergent Adverse Event (AE) as a Measure of the Safety and Tolerability of VNS in Patients With Gastroparesis | Serious AE | 0 Participants |
| Diabetic Gastroparesis | Number of Participants With Any Serious or Treatment-emergent Adverse Event (AE) as a Measure of the Safety and Tolerability of VNS in Patients With Gastroparesis | Treatment-emergent AE | 0 Participants |
| Functional Dyspepsia | Number of Participants With Any Serious or Treatment-emergent Adverse Event (AE) as a Measure of the Safety and Tolerability of VNS in Patients With Gastroparesis | Serious AE | 0 Participants |
| Functional Dyspepsia | Number of Participants With Any Serious or Treatment-emergent Adverse Event (AE) as a Measure of the Safety and Tolerability of VNS in Patients With Gastroparesis | Treatment-emergent AE | 0 Participants |
Secondary
PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain
The effect of VNS therapy on overall pain interference as assessed by the PROMIS (Patient Reported Outcomes Measurement Information System) pain interference questionnaire which is a 6 item questionnaire on a 5 point scale to assess the impact of pain on daily life. Scores are summed and converted to percentiles normalized for the population (normalized T-score). 50 indicates the population mean with a standard deviation of 10. The higher the T-score, the more severe the symptoms.
Time frame: Baseline, week 4, week 8
Population: Participants who received treatment and with data at the respective time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idiopathic Gastroparesis | PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain | Week 4 | 58.5 T-score | Standard Deviation 7.9 |
| Idiopathic Gastroparesis | PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain | Baseline | 64.5 T-score | Standard Deviation 5.6 |
| Idiopathic Gastroparesis | PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain | Week 8 | 63.6 T-score | Standard Deviation 8.3 |
| Diabetic Gastroparesis | PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain | Week 4 | 65.5 T-score | — |
| Diabetic Gastroparesis | PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain | Baseline | 66.9 T-score | — |
| Functional Dyspepsia | PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain | Week 4 | 58.8 T-score | Standard Deviation 2.7 |
| Functional Dyspepsia | PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain | Baseline | 54.3 T-score | Standard Deviation 8 |
| Functional Dyspepsia | PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain | Week 8 | 55.3 T-score | Standard Deviation 10 |
Secondary
Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health
The effect of VNS therapy on overall wellbeing and health as assessed by the SF-12. Score range: 0-100, higher scores correspond to better quality of life.
Time frame: Baseline, week 4, week 8
Population: Participants who received treatment and with data at the respective time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idiopathic Gastroparesis | Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health | Week 4 | 66.6 score on a scale | Standard Deviation 29.7 |
| Idiopathic Gastroparesis | Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health | Baseline | 64.2 score on a scale | Standard Deviation 28 |
| Idiopathic Gastroparesis | Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health | Week 8 | 63.1 score on a scale | Standard Deviation 29 |
| Diabetic Gastroparesis | Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health | Week 4 | 37.7 score on a scale | — |
| Diabetic Gastroparesis | Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health | Baseline | 28.8 score on a scale | — |
| Functional Dyspepsia | Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health | Week 4 | 44.1 score on a scale | Standard Deviation 11.2 |
| Functional Dyspepsia | Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health | Baseline | 37.5 score on a scale | Standard Deviation 8.4 |
| Functional Dyspepsia | Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health | Week 8 | 43 score on a scale | Standard Deviation 10.8 |
Secondary
The Effect of VNS Therapy on Gastric and Small Intestine Leukocyte Infiltration.
The effects of VNS therapy on gastric and small intestine leukocyte infiltration was measured as relative abundance (normalized ratio) of immune cells (identified via CD45 marker) to total live cells across tissue leukocytes from endoscopic mucosal biopsies before and after VNS, using flow cytometry.
Time frame: Baseline (pre-VNS) and 4 weeks (post-VNS)
Population: Participants who received treatment in the Idiopathic Gastroparesis group; data were not collected in the Diabetic Gastroparesis or Functional Dyspepsia groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idiopathic Gastroparesis | The Effect of VNS Therapy on Gastric and Small Intestine Leukocyte Infiltration. | Baseline | 0.76 immune cell:total live cell ratio | Standard Deviation 0.1 |
| Idiopathic Gastroparesis | The Effect of VNS Therapy on Gastric and Small Intestine Leukocyte Infiltration. | Week 4 | 0.76 immune cell:total live cell ratio | Standard Deviation 0.08 |