EpilepsyCORE-VNSNCT03529045
Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.
An observational study of Epilepsy and Seizures, run by LivaNova at 62 sites in 16 countries.
Trial summary
Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy, Seizures, Drug Resistant Epilepsy
- What is being tested?
- Vagus Nerve Stimulation (VNS) Therapy
- Type of treatment
- Medical device
- How many people
- 827 participants
- Where
- 62 sitesin 16 countries
- Study dates
- 5 Feb 2018to 11 Sep 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System. Eligible subjects include those receiving VNS Therapy for the first time, as well as those that are being re-implanted with VNS
Who may be able to join
- Clinical diagnosis of drug resistant epilepsy treated with VNS Therapy. Eligible subjects include those not previously treated with VNS Therapy as well as subjects receiving replacement generators.
- Able and willing to comply with the frequency of study visits.
- Subject, or legal guardian, understands study procedures and voluntarily signs an informed consent in accordance with institutional policies. In the event that the subject is under the age of 18, the subject may also be required (per EC/IRB) to sign an assent affirming their agreement to participate.
Who cannot join
- There are no exclusion criteria in this study. Investigators should refer to the local instructions for use for VNS Therapy.
Trial locations and contacts
62 sites in 16 countries.
62 sites in 16 countries
United States19 sites
Dent Neurosciences Research Center
Amherst, New York, 14226
Child Neurology Consultants of Austin
Austin, Texas, 78731
Duke University Hospital
Durham, North Carolina, 27710
St. Mary's Hospital
Grand Junction, Colorado, 81501
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Ascension Columbia St. Mary's Hospital
Milwaukee, Wisconsin, 53211
Tulane University
New Orleans, Louisiana, 70112
Research Institute of Orlando
Orlando, Florida, 32806
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny Neurology Associates
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
State University of New York
Syracuse, New York, 13210
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, 33609
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Via Christi Health
Wichita, Kansas, 67214
Valley Health System
Winchester, Virginia, 22601
Wake Forest University
Winston-Salem, North Carolina, 27157
United Kingdom6 sites
Southmead Hospital
Bristol, BS10 5NB
King's College Hospital
London
Royal Victoria Infirmary Hospital
Newcastle upon Tyne
Norfolk and Norwich Hospitals NHS Foundation Trust
Norwich
John Radcliffe Hospital
Oxford
Royal Hallamshire Hospital
Sheffield
Australia5 sites
Queensland Children's hospital
Brisbane, Queensland, 4101
The Alfred Hospital
Melbourne, Victoria, 3004
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
Royal Children's hospital
Melbourne, Victoria
Perth Children's Hospital
Perth, Western Australia, W1 6909
Canada5 sites
London Health Sciences Centre Research Inc.
London, Ontario, N6A 5A5
London Health Sciences Centre Research Inc. (London Victoria)
London, Ontario, N6C 2R5
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
The Research Institute of the McGill University Health Centre
Montreal, Quebec, H3H 2R9
China3 sites
Sanbo Brain Hospital Capital Medical University
Beijing
Xuanwu Hospital Capital Medical University
Beijing
Guangzhou Women and Children's Medical Center
Guangzhou
India3 sites
St.-John Medical College and Hospital
Bangalore
P.D. Hinduja National Hospital
Mumbai, Maharashra, 400016
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004
Israel3 sites
Schneider Children's Medical Center of Israel
Petah Tikva, 4920235
Sheba Medical Center
Ramat Gan
Sourasky Medical Center
Tel Aviv
Japan3 sites
National Center Hospital of Neurology and Psychiatry
Kodaira
National Hospital Organization Nagasaki Medical Center
Nagasaki
The University of Tokyo Hospital
Tokyo
Netherlands3 sites
Kempenhaeghe
Heeze
Sophia Kinderziekenhuis
Rotterdam, 3015 GD
Stichting Epilepsie Instellingen Nederland (SEIN)
Zwolle
Brazil2 sites
Fundação Felice Rosso, Hospital Felício Rocho
Belo Horizonte
Instituto Estadual do Cérebro Paulo Niemeyer
Rio de Janeiro
Italy2 sites
Ospedale Bellaria
Bologna, 40139
Bambino Gesu Pediatric Hospital
Rome
Poland2 sites
University Clinical Center
Katowice, 40-752
Children's Memorial Health Institute
Warsaw, 04-730
Saudi Arabia2 sites
King Faisal Specialist Hospital & Research Center
Jeddah
King Faisal Specialist Hospital & Research Center
Riyadh
About this study
Official title: CORE-VNS: Comprehensive Outcomes Registry in Subjects With Epilepsy Treated With Vagus Nerve Stimulation Therapy
Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.
Read the detailed description
The purpose of this registry is to evaluate clinical outcome and safety data in subjects with drug resistant epilepsy treated with the VNS Therapy System. The study will collect outcomes for subjects treated with VNS Therapy in a real-world setting.
- Conditions
- Epilepsy, Seizures, Drug Resistant Epilepsy
- Being tested
- Vagus Nerve Stimulation (VNS) Therapy
- Keywords
- VNS, VNS Therapy, Vagus Nerve Stimulation
- Medical subject headings
- Epilepsy, Seizures, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve Stimulation (VNS) TherapyDevice
The VNS Therapy System is a commercially available device that will be used by licensed medical practitioners trained in the use of VNS Therapy, per the practitioners' medical judgement.
| Study group | Role | What they receive |
|---|---|---|
| VNS Therapy | Any approved VNS Therapy System (according to local regulations) may be used in this registry. Receives: Device: Vagus Nerve Stimulation (VNS) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Frequency
The average seizure frequency per month over the last 3 months (by type) will be collected
Measured: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Maximum Seizure Free Period
The maximum seizure free period over the last 3 months will be collected
Measured: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Seizure Severity
Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe
Measured: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Post-ictal Severity
Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe
Measured: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Change in Quality of Life
Quality of life is a categorical outcome and will be rated by the subject using the following categories: Very good: could hardly be better, Pretty good, Good and bad parts about equal, Pretty bad, Very bad: could hardly be worse
Measured: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Quality of Sleep
Quality of sleep will be reported using the Pittsburgh Sleep Quality Index for subjects 18 years and older and using the Children's Sleep Habit Questionnaire for subjects 2-17 years old; quality of sleep will not be assessed in children under 2 years old
Measured: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Anti-epileptic Drug Use
The name and dose of anti-epileptic drugs used will be collected on a case report form
Measured: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Rescue Drug Use
The number of times a rescue drug was used will be collected
Measured: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Seizure Related Emergency Department Visits
The number of times a patient had a seizure related emergency department (ED) visit will be collected
Measured: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Seizure Related Hospitalizations
The number of times a patient had a seizure related inpatient hospitalization and the length of each stay will be collected
Measured: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start5 Feb 2018
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- 827 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Way, Study director, LivaNova, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529045
- Sponsor's protocol ID
- LNN-801
- Acronym
- CORE-VNS
- Status last verified
- Nov 2024
- First submitted
- 22 Feb 2018
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Ekinci O, Isik U, Gunes S, Ekinci N. Understanding sleep problems in children with epilepsy: Associations with quality of life, Attention-Deficit Hyperactivity Disorder and maternal emotional symptoms. Seizure. 2016 Aug;40:108-13. doi: 10.1016/j.seizure.2016.06.011. Epub 2016 Jun 27.
PubMed 27394056Goodlin-Jones BL, Sitnick SL, Tang K, Liu J, Anders TF. The Children's Sleep Habits Questionnaire in toddlers and preschool children. J Dev Behav Pediatr. 2008 Apr;29(2):82-88. doi: 10.1097/dbp.0b013e318163c39a.
PubMed 18478627Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
PubMed 10660394Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.
PubMed 19889013Owens JA, Spirito A, McGuinn M. The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep. 2000 Dec 15;23(8):1043-51.
PubMed 11145319von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
PubMed 18064739Sen A, Verner R, Valeriano JP, Lee R, Zafar M, Thomas R, Kotulska K, Jespers E, Dibue M, Kwan P; CORE-VNS Registry Group. Vagus nerve stimulation therapy in people with drug-resistant epilepsy (CORE-VNS): rationale and design of a real-world post-market comprehensive outcomes registry. BMJ Neurol Open. 2021 Dec 23;3(2):e000218. doi: 10.1136/bmjno-2021-000218. eCollection 2021.
PubMed 35018342Kwan P, Boffini M, Fahoum F, El Tahry R, O'Brien TJ, Keough K, Boggs J, Goldberg-Stern H, Beraldi F, Giannicola G, Lee YC, Sen A; CORE-VNS Registry Group. Baseline characteristics and predictors for early implantation of vagus nerve stimulation therapy in people with drug-resistant epilepsy: Observations from an international prospective outcomes registry (CORE-VNS). Epilepsia Open. 2024 Oct;9(5):1837-1846. doi: 10.1002/epi4.13015. Epub 2024 Aug 24.
PubMed 39180426
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORE-VNS: Comprehensive Outcomes Registry in Subjects With Epilepsy Treated With Vagus Nerve Stimulation Therapy
- ClinicalTrials.gov ID
- NCT03529045
- Acronym / sponsor ID
- CORE-VNS / LNN-801
- Conditions
- Epilepsy, Seizures, Drug Resistant Epilepsy
- Keywords
- VNS, VNS Therapy, Vagus Nerve Stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 827 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.
Detailed description
The purpose of this registry is to evaluate clinical outcome and safety data in subjects with drug resistant epilepsy treated with the VNS Therapy System. The study will collect outcomes for subjects treated with VNS Therapy in a real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VNS Therapy | – | Device: Vagus Nerve Stimulation (VNS) TherapyAny approved VNS Therapy System (according to local regulations) may be used in this registry. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System. Eligible subjects include those receiving VNS Therapy for the first time, as well as those that are being re-implanted with VNS
Key inclusion criteria (3 listed)
- Clinical diagnosis of drug resistant epilepsy treated with VNS Therapy. Eligible subjects include those not previously treated with VNS Therapy as well as subjects receiving replacement generators.
- Able and willing to comply with the frequency of study visits.
- Subject, or legal guardian, understands study procedures and voluntarily signs an informed consent in accordance with institutional policies. In the event that the subject is under the age of 18, the subject may also be required (per EC/IRB) to sign an assent affirming their agreement to participate.
Key exclusion criteria (1 listed)
- There are no exclusion criteria in this study. Investigators should refer to the local instructions for use for VNS Therapy.
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 (VNS) TherapyThe VNS Therapy System is a commercially available device that will be used by licensed medical practitioners trained in the use of VNS Therapy, per the practitioners' medical judgement. | Device | VNS Therapy |
Primary outcome
Seizure Frequency
Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
The average seizure frequency per month over the last 3 months (by type) will be collected
Maximum Seizure Free Period
Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
The maximum seizure free period over the last 3 months will be collected
Seizure Severity
Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe
Post-ictal Severity
Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe
Change in Quality of Life
Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Quality of life is a categorical outcome and will be rated by the subject using the following categories: Very good: could hardly be better, Pretty good, Good and bad parts about equal, Pretty bad, Very bad: could hardly be worse
Quality of Sleep
Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Quality of sleep will be reported using the Pittsburgh Sleep Quality Index for subjects 18 years and older and using the Children's Sleep Habit Questionnaire for subjects 2-17 years old; quality of sleep will not be assessed in children under 2 years old
Anti-epileptic Drug Use
Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
The name and dose of anti-epileptic drugs used will be collected on a case report form
Rescue Drug Use
Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
The number of times a rescue drug was used will be collected
Seizure Related Emergency Department Visits
Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
The number of times a patient had a seizure related emergency department (ED) visit will be collected
Seizure Related Hospitalizations
Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
The number of times a patient had a seizure related inpatient hospitalization and the length of each stay will be collected
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 27394056Ekinci O, Isik U, Gunes S, Ekinci N. Understanding sleep problems in children with epilepsy: Associations with quality of life, Attention-Deficit Hyperactivity Disorder and maternal emotional symptoms. Seizure. 2016 Aug;40:108-13. doi: 10.1016/j.seizure.2016.06.011. Epub 2016 Jun 27.
- Background: PubMed 18478627Goodlin-Jones BL, Sitnick SL, Tang K, Liu J, Anders TF. The Children's Sleep Habits Questionnaire in toddlers and preschool children. J Dev Behav Pediatr. 2008 Apr;29(2):82-88. doi: 10.1097/dbp.0b013e318163c39a.
- Background: PubMed 10660394Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
- Background: PubMed 19889013Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.
- Background: PubMed 11145319Owens JA, Spirito A, McGuinn M. The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep. 2000 Dec 15;23(8):1043-51.
- Background: PubMed 18064739von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
- Results publication: PubMed 35018342Sen A, Verner R, Valeriano JP, Lee R, Zafar M, Thomas R, Kotulska K, Jespers E, Dibue M, Kwan P; CORE-VNS Registry Group. Vagus nerve stimulation therapy in people with drug-resistant epilepsy (CORE-VNS): rationale and design of a real-world post-market comprehensive outcomes registry. BMJ Neurol Open. 2021 Dec 23;3(2):e000218. doi: 10.1136/bmjno-2021-000218. eCollection 2021.
- Results publication: PubMed 39180426Kwan P, Boffini M, Fahoum F, El Tahry R, O'Brien TJ, Keough K, Boggs J, Goldberg-Stern H, Beraldi F, Giannicola G, Lee YC, Sen A; CORE-VNS Registry Group. Baseline characteristics and predictors for early implantation of vagus nerve stimulation therapy in people with drug-resistant epilepsy: Observations from an international prospective outcomes registry (CORE-VNS). Epilepsia Open. 2024 Oct;9(5):1837-1846. doi: 10.1002/epi4.13015. Epub 2024 Aug 24.
- Individual participant dataSharing planned: No
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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.
Jeffrey Way study director
LivaNova, Inc.
62 sites in 16 countries: 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 LivaNova at 62 sites in 16 countries.
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 3 inclusion and 1 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 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, United Kingdom, Australia, Canada, China and 11 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Seizure Frequency (time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable). The study lists 10 primary outcomes in all. 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 NCT03529045, which also lists 9 linked publications.
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 22 Nov 2024.