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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Vagus Nerve Stimulation Therapy Standard Titration |
| |
| Group B | Vagus Nerve Stimulation Therapy Alternate Titration 1 |
| |
| Group C | Vagus Nerve Stimulation Therapy Alternate Titration 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus Nerve Stimulation Therapy | Device | Stimulation of the left tenth cranial nerve via VNS Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks post implant |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Way | Cyberonics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| Loma Linda University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37429122 | Derived | 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. |
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All subjects were required to receive implantation of a commercially available Vagus Nerve Stimulation generator (Stimulation of the left tenth cranial nerve via VNS Therapy) prior to randomization. The generator was to remain "off" until after randomization completion.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Vagus Nerve Stimulation Therapy Standard Titration method |
| FG001 | Group B | Vagus Nerve Stimulation Therapy Alternate Titration 1 Alternate titration method that combined methods from Group A and Group C. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
| FG002 | Group C | Vagus Nerve Stimulation Therapy Alternate Titration 2 Alternate titration method used in the ANTHEM-HF trial which evaluated the performance of autonomic regulation using VNS Therapy in patients with chronic symptomatic heart failure and reduced ejection fraction. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Vagus Nerve Stimulation Therapy Standard Titration method |
| BG001 | Group B | Vagus Nerve Stimulation Therapy Alternate Titration 1 Alternate titration method that combined methods from Group A and Group C. |
| BG002 | Group C | Vagus Nerve Stimulation Therapy Alternate Titration 2 Alternate titration method used in the ANTHEM-HF trial which evaluated the performance of autonomic regulation using VNS Therapy in patients with chronic symptomatic heart failure and reduced ejection fraction. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | 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 | 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. | Posted | Count of Participants | Participants | 12 weeks post implant |
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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.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Vagus Nerve Stimulation Therapy Standard Titration method | 0 | 22 | 0 | 22 | 9 | 22 |
| EG001 | Group B | Vagus Nerve Stimulation Therapy Alternate Titration 1 Alternate titration method that combined methods from Group A and Group C. | 0 | 20 | 0 | 20 | 7 | 20 |
| EG002 | Group C | Vagus Nerve Stimulation Therapy Alternate Titration 2 Alternate titration method used in the ANTHEM-HF trial which evaluated the performance of autonomic regulation using VNS Therapy in patients with chronic symptomatic heart failure and reduced ejection fraction. | 0 | 20 | 1 | 20 | 9 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (17.1) | Systematic Assessment | Peripheral vascular disease of right superficial femoral artery (Post Implant) unrelated to implant or stimulation. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpatations [S] | Cardiac disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Cerumen impaction [U] | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Tinnitus [U] | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Constipation [U] | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Diarrhoea [U] | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Dysphagia [S] | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Chest Pain [S] | General disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Discomfort [S] | General disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Fatigue [S] | General disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Implant site hoematoma [I] | General disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Medical device discomfort [S] | General disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Medical device pain [S] [SI] | General disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Non-cardiac chest pain [S] | General disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Cellulitis [U] | Infections and infestations | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Lower respiratory tract infection [U] | Infections and infestations | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Nasopharyngitis [U] | Infections and infestations | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Staphyloccal infection [I] | Infections and infestations | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Urinary tract infection [U] | Infections and infestations | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Incision site haematoma [U] | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Incision site hypoaesthesia [I] | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Incision site pain [I] | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Post procedural haemorrhage [U] | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Procedural headache [S] | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Procedural nausea [U] | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Arthralgia [U] | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Back pain [U] | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Muscle spasms [S] | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Muscle tightness [SI] | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Muscle twitching [S] | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Myalgia [I] | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Neck pain [I] | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Pain in extremety [I] | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Pain in jaw [U] [S] | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Convulsion [U] | Nervous system disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Headache [U] | Nervous system disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Migraine [U] | Nervous system disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Paraesthesia [S] | Nervous system disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Postural tremor [S] | Nervous system disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Somnolence [U] | Nervous system disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Anxiety [U] [SI] | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Asthma [U] | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Cough [S] | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Dysphonia [S] | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Oropharyngeal pain [I] [S] | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Sleep apnoea syndrome [S] | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Sputum increased [SI] | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Throat tightness [S] | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Pruritis [S] | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
|
| Peripheral arterial occlusive disease [U] | Vascular disorders | MedDRA (17.1) | Systematic Assessment | [S] Related to Stimulation [I] Related to Implant [SI] Related to Stimulation and Implant [U] Unrelated to Stimulation or Implant |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Sears, Clinical Project Manager | Cyberonics, Inc. | (281) 228-7597 | peter.sears@cyberonics.com |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Black or African American |
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| Hispanic or Latino |
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