Trial Outcomes & Findings for Optimization of VNS in Epileptic Patients to Induce Cardioprotection (NCT NCT04387435)
NCT ID: NCT04387435
Last Updated: 2025-04-06
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
Following the 4 - week VNS treatment phase to the of the end of study.
Results posted on
2025-04-06
Participant Flow
Participant milestones
| Measure |
Intervention Arm
Single arm
A change or titration in the current or frequency settings of the VNS therapy system.: 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.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Intervention Arm
Single arm
A change or titration in the current or frequency settings of the VNS therapy system.: 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.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Optimization of VNS in Epileptic Patients to Induce Cardioprotection
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=1 Participants
Single arm
A change or titration in the current or frequency settings of the VNS therapy system.: 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Following the 4 - week VNS treatment phase to the of the end of study.Population: Participant only completed first study visit and did not return
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From pre VNS setting changes (baseline) to post VNS setting changes (end of study).Outcome measures
Outcome data not reported
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Olujimi Ajijola, MD, Phd
University of California, Los Angeles
Phone: 310-206-2235
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place