EpilepsyASCENDNCT02385526

Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation

An observational study of Epilepsy and Seizures, run by Cyberonics, Inc. at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Epilepsy, Seizures
What is being tested?: Vagus Nerve Stimulation Therapy
Type of treatment: Medical device
How many people: 67 participants
Where: 15 sitesUnited States
Study dates: 28 Apr 2015to 10 Oct 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

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

Other trials in United States

About this study

Official title: ASCEND: Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation

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: Epilepsy, Seizures
Being tested: Vagus Nerve Stimulation Therapy
Keywords: Vagus Nerve Stimulation, ASCEND, VNS Titration to Improve Tolerance and Accelerate Adaptation
Medical subject headings: Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vagus Nerve Stimulation TherapyDevice
Also called VNS Therapy
Stimulation of the left tenth cranial nerve via VNS Therapy

Study groups in NCT02385526
Study group	Role	What they receive
Group A		Vagus Nerve Stimulation Therapy Standard Titration Receives: Device: Vagus Nerve Stimulation Therapy
Group B		Vagus Nerve Stimulation Therapy Alternate Titration 1 Receives: Device: Vagus Nerve Stimulation Therapy
Group C		Vagus Nerve Stimulation Therapy Alternate Titration 2 Receives: Device: Vagus Nerve Stimulation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 12 weeks post implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Apr 201510 Oct 2016

First posted11 Mar 2015 (estimated)
Study start28 Apr 2015
Primary completion10 Oct 2016
Study completion10 Oct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for EpilepsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02385526
Sponsor's protocol ID: E-40
Acronym: ASCEND
Status last verified: Oct 2017
First submitted: 5 Mar 2015
Last updated: 23 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bagic AI, Verner R, Afra P, Benbadis S; ASCEND Study Group. ASCEND: A randomized controlled trial of titration strategies for vagus nerve stimulation in drug-resistant epilepsy. Epilepsy Behav. 2023 Aug;145:109333. doi: 10.1016/j.yebeh.2023.109333. Epub 2023 Jul 8.
PubMed 37429122

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Electrocardiographic Changes Associated With Epilepsy
ECG Changes
Recruiting
Combined CM and STN Stimulation for Motor Epilepsy
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Not yet recruiting
Lily's Grace Temporal Interference
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Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ASCEND: Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
ClinicalTrials.gov ID: NCT02385526
Acronym / sponsor ID: ASCEND / E-40
Conditions: Epilepsy, Seizures
Keywords: Vagus Nerve Stimulation, ASCEND, VNS Titration to Improve Tolerance and Accelerate Adaptation
Study type: Observational
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Cyberonics, Inc.Industry (pharma, biotech, devices)
Study start: 28 Apr 2015 (actual)
Primary completion: 10 Oct 2016 (actual)
Study completion: 10 Oct 2016 (actual)
First posted: 11 Mar 2015 (estimated)
Results: Posted 23 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Group A	–	Device: Vagus Nerve Stimulation TherapyVagus Nerve Stimulation Therapy Standard Titration
Group B	–	Device: Vagus Nerve Stimulation TherapyVagus Nerve Stimulation Therapy Alternate Titration 1
Group C	–	Device: Vagus Nerve Stimulation TherapyVagus Nerve Stimulation Therapy Alternate Titration 2

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vagus Nerve Stimulation TherapyAlso: VNS TherapyStimulation of the left tenth cranial nerve via VNS Therapy	Device	Group A, Group B, Group C

Primary outcome

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

Results and safety

Results posted to the registry on 23 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	22	20
Group B	20	17
Group C	20	20

Primary outcome: Percent Patients Reaching the Defined Target Dose

Time frame: 12 weeks post implant. Count of participants. Unit: Participants

Measure	Group A n = 22	Group B n = 20	Group C n = 20
Value	18	9	12

Population analysed: Population of subjects implanted with Vagus Nerve Therapy generator who received stimulation via left, tenth cranial nerve at varying dosing methods (device settings adjustments) depending on the group each subject was randomized. All subject had a common, final target dose to achieve but used alternate methods to achieve the target dose.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	0 of 22 (0%)	9 of 22 (40.9%)	0 of 22
Group B	0 of 20 (0%)	7 of 20 (35%)	0 of 20
Group C	1 of 20 (5%)	9 of 20 (45%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37429122Bagic AI, Verner R, Afra P, Benbadis S; ASCEND Study Group. ASCEND: A randomized controlled trial of titration strategies for vagus nerve stimulation in drug-resistant epilepsy. Epilepsy Behav. 2023 Aug;145:109333. doi: 10.1016/j.yebeh.2023.109333. Epub 2023 Jul 8.

Related trials for Epilepsy

RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Electrocardiographic Changes Associated With Epilepsy
ECG Changes
Recruiting
Combined CM and STN Stimulation for Motor Epilepsy
Motor Epilepsy
Not yet recruiting
Lily's Grace Temporal Interference
Epilepsy
Not yet recruiting
Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
Refractory Epilepsy, Epilepsy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeff Way study director

Cyberonics, Inc.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy and Seizures, run by Cyberonics, Inc. at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Patients Reaching the Defined Target Dose (time frame: 12 weeks post implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02385526, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.