CompletedNCT02385526ASCENDUpdated Jul 23, 2018Results posted

Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation

An observational study in Epilepsy and Seizures, sponsored by Cyberonics, Inc.. Completed at 15 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-07-23.

Sponsored by Cyberonics, Inc. · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 67
Ages: 12 Years and older
Sex: All

Study summary

Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study to determine the number of patients achieving their final assigned VNS Therapy dose settings in patients with drug-resistant epilepsy who are being treated with adjunctive VNS Therapy using new titration protocols.

Read the detailed description

Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study is designed to determine which VNS Therapy titration paradigm allows more patients to achieve a therapeutic dose within a specified time frame. Additionally, the study will collect data on the acute tolerability and clinical outcomes for patients with drug-resistant epilepsy treated with adjunctive VNS Therapy employing three different titration paradigms.

Conditions studied

Epilepsy
Seizures

Browse trials for

Seizures 881

Keywords

Vagus Nerve Stimulation
ASCEND
VNS Titration to Improve Tolerance and Accelerate Adaptation

In context

Seizures

881 studies on the registry are indexed under Seizures; 143 are open to participants now.

This study's enrollment of 67 is below the median of 150 across 235 observational studies indexed under Seizures.

Browse Seizures studies →

Lead sponsor

Cyberonics, Inc. is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

The study shall include adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications and eligible for VNS Therapy indicated for use as an adjunctive therapy in reducing the frequency of seizures.

Inclusion criteria

Patients must agree to be treated with VNS Therapy. The decision to treat with VNS Therapy must have been made independent of and prior to participation in the study.
Patients must be 12 years or older and have partial onset seizures or must follow the indication for use statement for VNS Therapy.
Patient and/or caregiver must be able and willing to give accurate side effect reports, global impressions data and complete study instruments with minimal assistance throughout the study.
Patient or legal guardian understands study procedures and voluntarily signs an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional policies. In the event the patient is under the age of 18, the patient will also be required to sign an assent affirming agreement to participate in research according to local IRB requirements.
Patient must be taking at least 1 anti-epileptic drug treatment

Exclusion criteria

Exclusion Criteria:

Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
Patient is expected to require MRI using a body coil for transmission of RF during the clinical study.
Patient has a progressive neurological condition (e.g. brain tumor etc.).
In the investigator's opinion, the patient or legal guardian is unable to comply with the frequency of clinic visits during the study.
Patient is currently using an investigational device or pharmacologic medication not approved by the FDA.
Patient was previously implanted with VNS Therapy.
In the investigator's opinion, the patient is considered a suicide risk or is otherwise not a good candidate for this study.
Patient/Caregiver is unable to complete the required study follow-up visits and assessments.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 67 participants (actual)
Patient registry: No

Groups and cohorts

Group A
Vagus Nerve Stimulation Therapy Standard Titration
Device: Vagus Nerve Stimulation Therapy
Group B
Vagus Nerve Stimulation Therapy Alternate Titration 1
Device: Vagus Nerve Stimulation Therapy
Group C
Vagus Nerve Stimulation Therapy Alternate Titration 2
Device: Vagus Nerve Stimulation Therapy

Interventions

DeviceVagus Nerve Stimulation Therapy
Stimulation of the left tenth cranial nerve via VNS Therapy
Also known as: VNS Therapy

What researchers measure

Primary outcomes

Percent Patients Reaching the Defined Target Dose
Determination of the proportion (percent) of patients in each VNS Therapy titration group reaching the defined target dose within clinically defined titration time-frame
Time frame: 12 weeks post implant

Results

Posted Jul 23, 2018

Participant flow

Subjects enrolled at 15 clinical sites including university and private hospital clinics. Enrollment was allowed following successful initiation of the first clinical site on 04MAR2015 and closed on 29JUN2016. The first subject enrolled on 28APR2015 and the final two subjects enrolled on 29JUN2016. The final subject exited the study on 10OCT2016.

Participant flow — Overall Study
Milestone	Group A	Group B	Group C
Started	22	20	20
Completed	20	17	20
Not completed	2	3	0
Withdrew: Withdrawal by subject	0	2	0
Withdrew: Lost to follow-up	0	1	0
Withdrew: Physician decision	1	0	0
Withdrew: Protocol violation	1	0	0

Outcome measures

PrimaryPercent Patients Reaching the Defined Target Dose

Determination of the proportion (percent) of patients in each VNS Therapy titration group reaching the defined target dose within clinically defined titration time-frame

Time frame:: 12 weeks post implant
Reported as:: Count of participants · Participants

Percent Patients Reaching the Defined Target Dose
Participants	Group A	Group B	Group C
Percent Patients Reaching the Defined Target Dose	18	9	12

Adverse events

Collected over Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group A	0/22 (0%)	0/22 (0%)	9/22 (40.9%)
Group B	0/20 (0%)	0/20 (0%)	7/20 (35%)
Group C	0/20 (0%)	1/20 (5%)	9/20 (45%)

Most frequent serious events

Most frequent serious events
Event	Group A	Group B	Group C
Peripheral arterial occlusive diseaseVascular disorders	0/22	0/20	1/20

Most frequent other events

Showing 10 of 49

Most frequent other events
Event	Group A	Group B	Group C
Diarrhoea [U]Gastrointestinal disorders	0/22	0/20	3/20
Incision site pain [I]Injury, poisoning and procedural complications	0/22	3/20	0/20
Urinary tract infection [U]Infections and infestations	0/22	2/20	0/20
Somnolence [U]Nervous system disorders	0/22	0/20	2/20
Oropharyngeal pain [I] [S]Respiratory, thoracic and mediastinal disorders	1/22	2/20	0/20
Neck pain [I]Musculoskeletal and connective tissue disorders	2/22	0/20	0/20
Cough [S]Respiratory, thoracic and mediastinal disorders	2/22	0/20	0/20
Throat tightness [S]Respiratory, thoracic and mediastinal disorders	2/22	0/20	0/20
Palpatations [S]Cardiac disorders	0/22	1/20	0/20
Cerumen impaction [U]Ear and labyrinth disorders	0/22	0/20	1/20

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Group A	Group B	Group C	Total
<=18 years	1	0	0	1
Between 18 and 65 years	21	19	19	59
>=65 years	0	1	1	2

Sex: Female, Male
Sex: Female, Male(Participants)	Group A	Group B	Group C	Total
Female	16	11	10	37
Male	6	9	10	25

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Group A	Group B	Group C	Total
Race/Ethnicity — White Non-Hispanic	15	17	13	45
Race/Ethnicity — Black or African American	3	1	1	5
Race/Ethnicity — Hispanic or Latino	4	2	6	12

Region of Enrollment
Region of Enrollment(participants)	Group A	Group B	Group C	Total
United States	22	20	20	62

Study locations

15 sites

Barrow Neurological Institute
Phoenix, Arizona 85013, United States
Loma Linda University
Loma Linda, California 92354, United States
University of Southern California
Los Angeles, California 90033, United States
Tampa General Hospital
Tampa, Florida 33606, United States
Emory University
Atlanta, Georgia 30329, United States
Northwestern University
Chicago, Illinois 60611, United States
Rush University Medical Center
Chicago, Illinois 60612, United States
St. Joseph's Hospital
Lexington, Kentucky 40504, United States
University of Michigan
Ann Arbor, Michigan 48109, United States
Mercy Medical Research Institue
Springfield, Missouri 65804, United States
University of Nebraska
Omaha, Nebraska 68131, United States
University of Pittsburgh
Pittsburgh, Pennsylvania 15213, United States
Covenant Hospital
Lubbock, Texas 79410, United States
Scott & White Healthcare
Temple, Texas 76508, United States
University of Utah
Salt Lake City, Utah 84132, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02385526
Lead sponsor: Cyberonics, Inc.
Responsible party: Sponsor
First posted: Mar 11, 2015
Start date: Apr 28, 2015
Primary completion: Oct 10, 2016
Completion: Oct 10, 2016
Results posted: Jul 23, 2018
Last update: Jul 23, 2018

Study contacts

Jeff Way

study director · Cyberonics, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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