Optimization of VNS in Epileptic Patients to Induce Cardioprotection

NCT04387435 | Completed Results DMC

• 2 other identifiers: 19-002279OT2OD028201
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a non-randomized, prospective study in patients with a diagnosis of epilepsy and previously implanted FDA approved Vagus Nerve Stimulation (VNS) devices. The goal of this clinical investigation is to evaluate the effects of adjusting vagus nerve stimulation parameters to engage cardioprotective effects.

Conditions

Epilepsy; Sudden Cardiac Death

Keywords

Vagus Nerve Stimulation (VNS); Neuromodulation; Autonomics

Outcome Measures

Primary Outcomes (1)

• Change in Seizure Frequency or Duration Via a Routine Seizure History Used in Clinical Practice.

  Following the 4 - week VNS treatment phase to the of the end of study.

Secondary Outcomes (1)

• Change in Heart Rate and Blood Pressure in Response to Upright Tilt, Deep Breathing, Valsalva Maneuver and a Cold Pressor Test.

  From pre VNS setting changes (baseline) to post VNS setting changes (end of study).

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Single arm

Other: A change or titration in the current or frequency settings of the VNS therapy system.

Interventions

A change or titration in the current or frequency settings of the VNS therapy system. OTHER

The study treatment involves changing the output current or frequency of the default device settings in a FDA approved device for VNS therapy. The proposed frequency changes in this study are within the FDA approved output current and frequency levels.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of refractory epilepsy and implanted with a VNS device or are scheduled to be implanted with a VNS device.
• years of age or older
• Subjects must demonstrate willingness and ability to comply with study requirements

You may not qualify if:

• Other implantable neuromodulatory device (e.g., brain stimulator)
• Treatment with cholinergic or anticholinergic medication in the past month
• Pre-existing cardiac arrhythmia or presence of cardiac pacemaker/defibrillator
• History of dysautonomias
• History of vasovagal syncope
• Progressive neurological diseases other than epilepsy
• Women that are pregnant
• Cognitive or psychiatric deficit that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UCLA Health

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Epilepsy; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Olujimi Ajijola, MD, Phd
• Organization: University of California, Los Angeles

oajijola@mednet.ucla.edu

310-206-2235

Study Officials

• Olujimi Ajijola, MD, PhD

  UCLA Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 13, 2020
• Study Start: December 1, 2020
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: April 6, 2025
• Results First Posted: August 28, 2024

Record last verified: 2025-03

Locations

US (1)