Trial Outcomes & Findings for Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome. (NCT NCT04721171)

Last Updated: 2022-03-04

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

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.

Results posted on

2022-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	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. The 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.	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. The 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.
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=2 Participants 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.	Placebo Group n=2 Participants 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.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30 years STANDARD_DEVIATION 7 • n=5 Participants	34.5 years STANDARD_DEVIATION 2.1 • n=7 Participants	32.2 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

The amount of opioids used by the patient will be recorded in all subjects and will be converted into morphine equivalents for comparison

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Patient satisfaction will be assessed at end of 1 month

A validated patient satisfaction score will be used

Outcome measures

Outcome data not reported

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thangam Venkatesan

Medical College of Wisconsin

Phone: 262-226-9632

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place