Clinical trial for Epilepsy
Official title Microelectrode Recordings From the Vagus Nerve in Awake Humans
ClinicalTrials.gov ID: NCT06016686
What this study is testing
- What it's testing
- This study is testing whether different stimulation settings activate specific nerve fibers in people with epilepsy. It also looks at how the nerve responds to these settings.
- Who it's for
- You may be able to join if you have epilepsy and a VNS device implanted, and you are comfortable with a small needle test on your neck.
- What's involved
- You will have a small needle placed near your vagus nerve while you are awake. The team will record nerve signals and try different stimulation strengths, lengths, and frequencies. You will stay in the clinic for the test and may have a short follow‑up visit.
- Time commitment
- The study lasts about one day for the main test, with a brief follow‑up visit a few weeks later. You will need to come to the clinic for the recording and any follow‑up appointments.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join if
- The participant is greater than or equal to (≥)18 years and is less than or equal to (≤) 40 years of age
- English speaking
- Medicare covered or equivalent health insurance from a partner country
You likely can't join if
- Pregnant
- Smokes and is unwilling to abstain from smoking on the day of the experiment.
- Inability or unwillingness to provide written informed consent.
- Individuals with difficulty standing unassisted for 5 minutes during the tilt-table testing
- Individuals found to have a significant carotid artery plaque or intima-media thickness \> 1 mm as assessed by ultrasonography during the...
- Vagus nerve not visible on ultrasound
See the full eligibility criteria
- The participant is greater than or equal to (≥)18 years and is less than or equal to (≤) 40 years of age
- English speaking
- Medicare covered or equivalent health insurance from a partner country
- Pregnant
- Smokes and is unwilling to abstain from smoking on the day of the experiment.
- Inability or unwillingness to provide written informed consent.
- Individuals with difficulty standing unassisted for 5 minutes during the tilt-table testing
- Individuals found to have a significant carotid artery plaque or intima-media thickness \> 1 mm as assessed by ultrasonography during the ultrasound-screening steps of the study visit
- Vagus nerve not visible on ultrasound
- VNS electrodes are not in a suitable location to allow for microelectrode insertion
- Any other clinical reasons deemed by the investigators
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, 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, but 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, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.