Cyclic Vomiting Syndrome
Conditions
Brief summary
We hypothesize that 1) Neurostimulation via a novel auricular percutaneous electrical nerve field stimulation (PENFS) device is a safe, non-invasive opioid-sparing alternative therapy for severe abdominal pain, nausea, and vomiting associated with CVS and will reduce the need for opioids. We also hypothesize that 2) PENFS reduces the length of stay (LOS), and improves patient satisfaction. We propose the following specific aim: Aim 1. Investigate the efficacy of PENFS compared to a sham in patients with CVS seen in the ED or in the clinic or hospitalized with an acute CVS episode. Objectives: 1. Demonstrate reduction in abdominal pain, nausea, and vomiting using validated tools. 2. Obviate or reduce the need for opioids. 3. Reduce the length of hospital stay and improve patient satisfaction. This approach will specifically address the current opioid problem using a novel, non-invasive neurostimulation therapy with proven efficacy for opioid withdrawal. Long-term, it may improve health care outcomes and significantly reduce overall health care costs.
Detailed description
Opioid use in CVS and the critical need for opioid sparing therapy Given the lack of knowledge about pathophysiology and evidence-based therapies, patients are often hospitalized to treat symptoms of CVS. During an episode, patients present with severe vomiting and abdominal pain and are treated empirically with IV fluids, antiemetics, benzodiazepines, and opioids. Estimates of opioid use range from 23%-27% in adults with CVS. Patients are often dissatisfied with the level of analgesia as recurrent opioid use results in tolerance and dependence. This often undermines the physician-patient relationship and patients even leave against medical advice out of frustration with what they perceive as ineffective care. This can lead to worse outcomes including recurrent hospitalizations, morbidity and increased health care costs. Preliminary data from a study by our group reveals that of 101 patients hospitalized with CVS at Froedtert Hospital, chronic opioid therapy is associated with a two-fold increased risk of hospitalization (RR 2.22, CI 1.1-4.4, P=0.02) and three-fold increase in hospital length of stay (LOS) (RR 3.43, CI 1.26-9.34, P=0.01). In a study of 132 CVS patients, opioid use was associated with non-response to amitriptyline (53% vs 15%, p\<0.05), a prophylactic therapy used in CVS. This in turn was associated with increased frequency and duration of CVS episodes per year and increased number of hospitalizations/emergency department (ED) visits at baseline (18% vs 15.2%, p\<0.05). Hence there is an urgent need for an opioid-sparing, non-invasive strategy to treat CVS symptoms. In summary, CVS is common and disabling and is associated with significant health care costs. Our proposed project using a novel, non-invasive device to treat CVS will also address the current opioid crisis.
Interventions
DEVICEThe Bridge device
he Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Sham versus real device
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Patients who meet Rome criteria for cyclic vomiting syndrome and are in an acute episode.
Exclusion criteria
* Developmental delay * Non-English speaking patients * Pregnancy * Any implanted electrical device * Any significant dermatological/infectious condition of the ear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Abdominal Pain | The change in abdominal pain will be measured at baseline (before intervention) and then at 2 hours, 24 hours and at 5 days post intervention. | Abdominal pain will be assessed through Visual Analog Scale with the score of ranging from 0 to 10, with 0 being the least and 10 being the worst pain. |
| Change in Need for Opioids Between Device and Sham | The dose of opioids use ( morphine equivalent) will be measured at baseline (before intervention) and then at 2 hours, 24 hours and at 5 days post intervention. | The amount of opioids used by the patient will be recorded in all subjects and will be converted into morphine equivalents for comparison |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Index for Nausea, Vomiting and Retching (INVR) Scores | The INVR scores will be assessed be measured at baseline (before intervention) and then at 2 hours, 24 hours and at 5 days post intervention. | The severity of daily nausea, vomiting and retching will be assessed using the Index for Nausea, Vomiting and Retching (INVR). This is a validated tool to measure the severity of nausea, vomiting and retching. The scores range from 0-32 with 0 being the least severe and 32 being the most severe. |
| Length of Stay in the Hospital (LOS) | LOS will be determined at end of 1 month | Hospital Length of stay (LOS) in days which refers to the no of days that the patient was admitted in the inpatient ward or unit |
| Patient Satisfaction | Patient satisfaction will be assessed at end of 1 month | A validated patient satisfaction score will be used |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORThangam Venkatesan
MCW
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group The Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days. | 2 |
| Placebo Group The sham is similar in appearance to the Bridge device but does not deliver any electrical stimulation and is a sham that is designed to look identical to the Bridge device. It is placed on the external ear at the beginning of the study and removed by the patient after 5 days. | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Placebo Group | Total | Intervention Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Continuous | 34.5 years STANDARD_DEVIATION 2.1 | 32.2 years STANDARD_DEVIATION 4.9 | 30 years STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 2 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Change in Need for Opioids Between Device and Sham
The amount of opioids used by the patient will be recorded in all subjects and will be converted into morphine equivalents for comparison
Time frame: The dose of opioids use ( morphine equivalent) will be measured at baseline (before intervention) and then at 2 hours, 24 hours and at 5 days post intervention.
Population: Data not collected.
Primary
Change in Severity of Abdominal Pain
Abdominal pain will be assessed through Visual Analog Scale with the score of ranging from 0 to 10, with 0 being the least and 10 being the worst pain.
Time frame: The change in abdominal pain will be measured at baseline (before intervention) and then at 2 hours, 24 hours and at 5 days post intervention.
Population: Data was not collected due to entry problem with participants not adding identifying information with their logs.
Secondary
Change in Index for Nausea, Vomiting and Retching (INVR) Scores
The severity of daily nausea, vomiting and retching will be assessed using the Index for Nausea, Vomiting and Retching (INVR). This is a validated tool to measure the severity of nausea, vomiting and retching. The scores range from 0-32 with 0 being the least severe and 32 being the most severe.
Time frame: The INVR scores will be assessed be measured at baseline (before intervention) and then at 2 hours, 24 hours and at 5 days post intervention.
Secondary
Length of Stay in the Hospital (LOS)
Hospital Length of stay (LOS) in days which refers to the no of days that the patient was admitted in the inpatient ward or unit
Time frame: LOS will be determined at end of 1 month
Secondary
Patient Satisfaction
A validated patient satisfaction score will be used
Time frame: Patient satisfaction will be assessed at end of 1 month