Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy

Ghent University Hospital (UZ)

Status: Completed

Conditions: Epilepsy

Treatments: Procedure: Vagus nerve stimulation paradigm #2; Procedure: Vagus nerve stimulation paradigm #3; Procedure: Vagus nerve stimulation paradigm #1

Study type: Interventional

Funder types: Other

Identifiers

NCT00782249

2005/238

Details and patient eligibility

About

Patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradigms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.

Enrollment: 31 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 16 years or older
• At least 1 seizure/month with alteration of consciousness
• Documented seizure diary, at least 3 months prior to implantation (baseline)
• No change in anti-epileptic drugs 1 month before implantation
• At least one or more AEDs

Exclusion criteria

• Active cardiac, pulmonary or gastrointestinal disease
• Vagotomy
• Concomitant use of an investigational drug
• Unstable medical condition
• Unstable psychiatric condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

31 participants in 3 patient groups

1

Experimental group

Description:

Vagus nerve stimulation paradigm #1

Treatment:

Procedure: Vagus nerve stimulation paradigm #1

2

Experimental group

Description:

Vagus nerve stimulation paradigm #2

Treatment:

Procedure: Vagus nerve stimulation paradigm #2

3

Experimental group

Description:

Vagus nerve stimulation paradigm #3

Treatment:

Procedure: Vagus nerve stimulation paradigm #3