Trial Outcomes & Findings for Non-invasive Vagus Nerve Stimulation in the Treatment of Crohn's Disease - A Pilot Study (NCT NCT05165108)

Last Updated: 2025-03-06

Results Overview

This test can identify the level of inflammation in the colon of a person with Crohn's Disease. If a person diagnosed with Crohn's Disease subsequently shows low levels (50 -200 ug/mg) of fecal calprotectin, this means that the inflammation is being controlled, so the treatment regime is working.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

Baseline and 16 weeks

Results posted on

2025-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Non-Invasive VNS Non-Invasive VNS will decrease inflammation in people with Crohn's disease leading to decrease in inflammatory markers and symptoms of disease. Vagal Nerve Stimulator: A handheld device which consists of a battery powered portable stimulator with a digital control user interface that controls signal amplitude and two steel contact electrodes will deliver the nVNS electrical stimulation to the cervical Vagus nerve. The device has been approved by the U.S. Food and Drug Administration (FDA) for non-invasive Vagus nerve stimulator therapy for adjunctive use for the prevention and treatment of migraine and cluster headaches in adult patients.
Overall Study STARTED	4
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-invasive Vagus Nerve Stimulation in the Treatment of Crohn's Disease - A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Invasive VNS n=4 Participants Non-Invasive VNS will decrease inflammation in people with Crohn's disease leading to decrease in inflammatory markers and symptoms of disease. Vagal Nerve Stimulator: A handheld device which consists of a battery powered portable stimulator with a digital control user interface that controls signal amplitude and two steel contact electrodes will deliver the nVNS electrical stimulation to the cervical Vagus nerve. The device has been approved by the U.S. Food and Drug Administration (FDA) for non-invasive Vagus nerve stimulator therapy for adjunctive use for the prevention and treatment of migraine and cluster headaches in adult patients.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31.5 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 16 weeks

Population: Data was only able to be collected from 1 participant at Week 16.

Outcome measures

Outcome measures
Measure	Non-Invasive VNS n=1 Participants Non-Invasive VNS will decrease inflammation in people with Crohn's disease leading to decrease in inflammatory markers and symptoms of disease. Vagal Nerve Stimulator: A handheld device which consists of a battery powered portable stimulator with a digital control user interface that controls signal amplitude and two steel contact electrodes will deliver the nVNS electrical stimulation to the cervical Vagus nerve. The device has been approved by the U.S. Food and Drug Administration (FDA) for non-invasive Vagus nerve stimulator therapy for adjunctive use for the prevention and treatment of migraine and cluster headaches in adult patients.
Change in Fecal Calprotectin From Baseline to 16 Weeks	-102 ug/mg Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline and 16 Weeks

Population: Enrolled/Randomized patients

CDAI range is minimum 0 and maximum 450. Zero is best score. Four hundred and fifty is the worst score. Lowering the CDAI score by 70 points or more is the goal for this study. A CDAI score of \< or = 150 is considered remission.

Outcome measures

Outcome measures
Measure	Non-Invasive VNS n=2 Participants Non-Invasive VNS will decrease inflammation in people with Crohn's disease leading to decrease in inflammatory markers and symptoms of disease. Vagal Nerve Stimulator: A handheld device which consists of a battery powered portable stimulator with a digital control user interface that controls signal amplitude and two steel contact electrodes will deliver the nVNS electrical stimulation to the cervical Vagus nerve. The device has been approved by the U.S. Food and Drug Administration (FDA) for non-invasive Vagus nerve stimulator therapy for adjunctive use for the prevention and treatment of migraine and cluster headaches in adult patients.
Change in Crohn's Disease Activity Index (CDAI) From Baseline to 16 Weeks	275.7 score on a scale Standard Error .1

SECONDARY outcome

Timeframe: 16 Weeks

Population: No data was collected for this endpoint. This outcome was not measured due to lack of funding available for the project.

Cytokine levels within the blood will be assessed and compared to baseline levels. The cytokines being assayed include C- reactive protein, tumor necrosis factor-alpha, Interferon-gamma, Transforming Growth Factor-beta and Interleukins (IL) - 1, 6, 10, 12, 17, 21, 23. (all cytokines will be presented at pg/mL)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 Weeks

Population: No data was collected for this endpoint. Heart Rate Variability data was not made available to MD and staff because of staffing changes.

Heart Rate Variability (HRV)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline Visit

Population: No data was collected for this endpoint. This was not measured due to lack of funding for the project.

Serum Insulin levels in the blood will be assessed and compared prior to stimulation, and at 20 minutes and 40 minutes after the stimulation. (presented as mCU/mL)

Outcome measures

Outcome data not reported

Adverse Events

Non-Invasive VNS

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

Thomas Nowak, MD

IndianaU

Phone: 3179484272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place