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New treatment option for Autoimmune Diseases
Official title VNS Prospective Neuromodulation of Immune and Gastrointestinal Systems
ClinicalTrials.gov ID: NCT03953768
What this study is testing
- What it's testing
- Vagal nerve stimulation is a neurosurgical procedure consisting of implantation of an impulse generator battery with leads placed into the vagus nerve in the neck. This procedure was FDA approved for epilepsy in the 1990s and is commonly performed as an outpatient surgery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 60
You may be able to join if
- Undergoing VNS implantation for the first time as a treatment for epilepsy and
- Documented follow up with a Louisville-based neurologist in the past 1 year. If at the University of Utah or Baylor University documented ability to...
- Documented ability to travel to Louisville for outpatient medical care. If at the University of Utah or Baylor University documented ability to...
You likely can't join if
- Previous treatment with VNS (other than the one implanted for this study)
- Current pregnancy (contraindication to surgery)
- Active infection
- History of cancer or treatment with chemotherapy
- History of autoimmune disease: Patients who received high effect anticholinergic medication within 30 days of enrollment will be excluded, whereas...
- If any high effect anticholinergic medication is started after enrollment, it will be the PI's decision to drop or postpone the corresponding visit...
See the full eligibility criteria
- Undergoing VNS implantation for the first time as a treatment for epilepsy and
- Documented follow up with a Louisville-based neurologist in the past 1 year. If at the University of Utah or Baylor University documented ability to travel to their corresponding neurologist.
- Documented ability to travel to Louisville for outpatient medical care. If at the University of Utah or Baylor University documented ability to travel to their facilities.
- Previous treatment with VNS (other than the one implanted for this study)
- Current pregnancy (contraindication to surgery)
- Active infection
- History of cancer or treatment with chemotherapy
- History of autoimmune disease: Patients who received high effect anticholinergic medication within 30 days of enrollment will be excluded, whereas moderate to low effect anticholinergic medication will be discussed with...
- If any high effect anticholinergic medication is started after enrollment, it will be the PI's decision to drop or postpone the corresponding visit or exclude the patient entirely.
- Patients who received high effect corticosteroids within 30 days of enrollment will be excluded, whereas moderate to low effect corticosteroids will be discussed with and decided by the PI.
- If any high effect corticosteroid is started after enrollment, it will be the PI's decision to drop or postpone the corresponding visit or exclude the patient entirely.
- Treatment with antiarrhythmic or (heart) rate controlling medication,
- Pre-existing cardiac arrhythmia or presence of cardiac pacemaker / defibrillator
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louisville, Kentucky, United States; Houston, Texas, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.