Epilepsy, seizure disorder, convulsive disorder, convulsions, seizures Depression, (major) depressive disorder, clinical depression Stroke, cerebrovascular accident (CVA), stroke rehabilitation, motor rehabilitation Rheumatoid arthritis, autoimmune arthritis Epilepsy Depression Stroke Arthritis
Conditions
Interventions
Electrical stimulation will be delivered to the vagus nerve through electrodes on an Achieve Advance mapping catheter that is placed temporarily in the IJV. Stimulation will be delivered to the Achiev
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Subjects 18 – 35 years old.Body mass index (BMI) =18 and =30 kg/m2Healthy (as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine clinical laboratory parameters)Able to comprehend and sign the information letter and Informed Consent (IC) prior to enrolment in the study
Exclusion criteria
Exclusion criteria: Any active implanted devicePregnancy or lactatingVascular acces issues regarding the left internal jugular veinMRI contraindicationsAny active disease that causes some form of inflammation, recent (<1 month) acute illness, including infections or trauma and recent (<3 months) hospital admission or surgery with general anesthesiaAny active diseases or symptoms that need medication therapy (over the counter medication included), except for contraceptive methodsRecent (<3 months) participation in another experimental studyHistory, signs or symptoms of neurological, hematological or cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is the proportion of subjects with measurable endovascular vagus stimulation evoked compound action potentials. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary measures include characterizing the changes in physiologic and immunological parameters such as blood pressure, ECG, and inflammatory cytokines with stimulation. | — |
Countries
Netherlands
Contacts
Public ContactJ Koolen
Radboud Universitair Medisch Centrum
Outcome results
None listed