Trial Outcomes & Findings for Vagal Nerve Stimulation for Gastroparesis (NCT NCT03120325)
NCT ID: NCT03120325
Last Updated: 2023-09-13
Results Overview
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).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days)
Results posted on
2023-09-13
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
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).
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
1
|
6
|
|
Overall Study
Used Device (Received Treatment)
|
15
|
1
|
5
|
|
Overall Study
COMPLETED
|
15
|
1
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data were not collected for the "Diabetic Gastroparesis" and "Functional Dyspepsia" groups.
Baseline characteristics by cohort
| Measure |
Idiopathic Gastroparesis
n=15 Participants
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).
|
Diabetic Gastroparesis
n=1 Participants
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).
|
Functional Dyspepsia
n=5 Participants
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).
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
1 Participants
n=1 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=15 Participants
|
1 Participants
n=1 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=15 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=15 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
3 Participants
n=15 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
1 Participants
n=1 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=21 Participants
|
|
Plasma cytokines
|
1 Normalized mean fluoresc ent intensity
STANDARD_DEVIATION 0.3 • n=15 Participants • Data were not collected for the "Diabetic Gastroparesis" and "Functional Dyspepsia" groups.
|
—
|
—
|
1 Normalized mean fluoresc ent intensity
STANDARD_DEVIATION 0.3 • n=15 Participants • Data were not collected for the "Diabetic Gastroparesis" and "Functional Dyspepsia" groups.
|
PRIMARY outcome
Timeframe: Baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days)Population: Participants who received treatment are included in the analysis.
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).
Outcome measures
| Measure |
Idiopathic Gastroparesis
n=15 Participants
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).
|
Diabetic Gastroparesis
n=1 Participants
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).
|
Functional Dyspepsia
n=5 Participants
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).
|
|---|---|---|---|
|
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
|
2.68 score on a scale
Standard Deviation NA
Standard deviation not calculable with an n of 1
|
2.1 score on a scale
Standard Deviation 1.1
|
|
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
|
1.71 score on a scale
Standard Deviation NA
Standard deviation not calculable with an n of 1
|
1.7 score on a scale
Standard Deviation 1.0
|
|
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
|
2.36 score on a scale
Standard Deviation NA
Standard deviation not calculable with an n of 1
|
1.6 score on a scale
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Baseline and week 4 (3 hours to assess at each time point)Population: Participants who received treatment are included in the analysis.
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.
Outcome measures
| Measure |
Idiopathic Gastroparesis
n=15 Participants
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).
|
Diabetic Gastroparesis
n=1 Participants
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).
|
Functional Dyspepsia
n=5 Participants
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).
|
|---|---|---|---|
|
Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time
Baseline
|
155.1 minutes
Standard Deviation 40.2
|
140.8 minutes
Standard Deviation NA
Standard deviation not calculable with an n of 1
|
91.8 minutes
Standard Deviation 19.8
|
|
Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time
Week 4
|
129.0 minutes
Standard Deviation 37.0
|
120.7 minutes
Standard Deviation NA
Standard deviation not calculable with an n of 1
|
100.8 minutes
Standard Deviation 37.7
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8Population: Participants who received treatment and with data at the respective time point are included in the analysis.
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.
Outcome measures
| Measure |
Idiopathic Gastroparesis
n=15 Participants
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).
|
Diabetic Gastroparesis
n=1 Participants
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).
|
Functional Dyspepsia
n=5 Participants
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).
|
|---|---|---|---|
|
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
|
66.9 T-score
Standard Deviation NA
Standard deviation not calculable with an n of 1
|
54.3 T-score
Standard Deviation 8.0
|
|
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
|
65.5 T-score
Standard Deviation NA
Standard deviation not calculable with an n of 1
|
58.8 T-score
Standard Deviation 2.7
|
|
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
|
—
|
55.3 T-score
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8Population: Participants who received treatment and with data at the respective time point are included in the analysis.
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.
Outcome measures
| Measure |
Idiopathic Gastroparesis
n=15 Participants
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).
|
Diabetic Gastroparesis
n=1 Participants
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).
|
Functional Dyspepsia
n=5 Participants
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).
|
|---|---|---|---|
|
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
|
—
|
43 score on a scale
Standard Deviation 10.8
|
|
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 28.0
|
28.8 score on a scale
Standard Deviation NA
Standard deviation not calculable with an n of 1
|
37.5 score on a scale
Standard Deviation 8.4
|
|
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
|
37.7 score on a scale
Standard Deviation NA
Standard deviation not calculable with an n of 1
|
44.1 score on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: 8 weeksThe 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
Outcome measures
| Measure |
Idiopathic Gastroparesis
n=17 Participants
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).
|
Diabetic Gastroparesis
n=1 Participants
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).
|
Functional Dyspepsia
n=6 Participants
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).
|
|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8Population: Participants who received treatment and with data at the respective time point are included in the analysis.
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.
Outcome measures
| Measure |
Idiopathic Gastroparesis
n=15 Participants
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).
|
Diabetic Gastroparesis
n=1 Participants
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).
|
Functional Dyspepsia
n=5 Participants
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).
|
|---|---|---|---|
|
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
|
9.3 RFA (bpm^2/hertz)
Standard Deviation NA
Standard deviation not calculable with an n of 1
|
16.2 RFA (bpm^2/hertz)
Standard Deviation 36.7
|
|
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 84.0
|
2.2 RFA (bpm^2/hertz)
Standard Deviation NA
Standard deviation not calculable with an n of 1
|
11.2 RFA (bpm^2/hertz)
Standard Deviation 12.2
|
|
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
|
—
|
17.5 RFA (bpm^2/hertz)
Standard Deviation 25.5
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Idiopathic Gastroparesis
n=53 Cytokines
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).
|
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).
|
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).
|
|---|---|---|---|
|
Effect of VNS on Mucosal Inflammation
|
1 fold change of MFI
Standard Deviation 0.01
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Idiopathic Gastroparesis
n=15 Participants
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).
|
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).
|
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).
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
Adverse Events
Idiopathic Gastroparesis
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Diabetic Gastroparesis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Functional Dyspepsia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Idiopathic Gastroparesis
n=17 participants at risk
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).
|
Diabetic Gastroparesis
n=1 participants at risk
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).
|
Functional Dyspepsia
n=6 participants at risk
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).
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
1/17 • Baseline through week 8
|
0.00%
0/1 • Baseline through week 8
|
0.00%
0/6 • Baseline through week 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place