EpilepsyNCT00782249
Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
A study testing Vagus nerve stimulation paradigm #1, Vagus nerve stimulation paradigm #2 and Vagus nerve stimulation paradigm #3 in people with Epilepsy, run by University Hospital, Ghent at 2 sites in 2 countries.
Trial summary
Patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradigms. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Vagus nerve stimulation paradigm #1, Vagus nerve stimulation paradigm #2 and Vagus nerve stimulation paradigm #3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Sep 2005to 18 May 2009
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 years or older
- At least 1 seizure/month with alteration of consciousness
- Documented seizure diary, at least 3 months prior to implantation (baseline)
- No change in anti-epileptic drugs 1 month before implantation
- At least one or more AEDs
Who cannot join
- Active cardiac, pulmonary or gastrointestinal disease
- Vagotomy
- Concomitant use of an investigational drug
- Unstable medical condition
- Unstable psychiatric condition
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire
About this study
Official title: Prospective Randomized Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
Patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradigms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.
- Conditions
- Epilepsy
- Being tested
- Vagus nerve stimulation paradigm #1, Vagus nerve stimulation paradigm #2, Vagus nerve stimulation paradigm #3
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve stimulation paradigm #1Procedure or surgery
Vagus nerve stimulation parameters #1
Vagus nerve stimulation paradigm #2Procedure or surgery
Vagus nerve stimulation parameters #2
Vagus nerve stimulation paradigm #3Procedure or surgery
Vagus nerve stimulation parameters #3
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Vagus nerve stimulation paradigm #1 Receives: Procedure: Vagus nerve stimulation paradigm #1 |
| 2 | Experimental | Vagus nerve stimulation paradigm #2 Receives: Procedure: Vagus nerve stimulation paradigm #2 |
| 3 | Experimental | Vagus nerve stimulation paradigm #3 Receives: Procedure: Vagus nerve stimulation paradigm #3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type
Measured: After 6 and 12 months
Secondary outcomes (4)
VNS-related side effects
Measured: After 6 and 12 months
Battery life
Measured: After 6 and 12 months
Quality of life: changes in QOLIE 89 score
Measured: After 12 months
Mood assessment: changes in Beck depression scale scores
Measured: After 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study start28 Sep 2005
- Primary completion18 May 2009
- Study completion18 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
- Investigators
- Paul Boon, MD, PhD, Principal investigator, University Hospital, GhentVijay Thadani, MD, Principal investigator, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782249
- Sponsor's protocol ID
- 2005/238
- Status last verified
- Feb 2023
- First submitted
- 29 Oct 2008
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT00782249
- Acronym / sponsor ID
- 2005/238
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 28 Sep 2005 (actual)
- Primary completion
- 18 May 2009 (actual)
- Study completion
- 18 May 2009 (actual)
- First posted
- 31 Oct 2008 (estimated)
- 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.
Patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradigms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Vagus nerve stimulation paradigm #1Vagus nerve stimulation paradigm #1 |
| 2 | Experimental | Procedure: Vagus nerve stimulation paradigm #2Vagus nerve stimulation paradigm #2 |
| 3 | Experimental | Procedure: Vagus nerve stimulation paradigm #3Vagus nerve stimulation paradigm #3 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 16 years or older
- At least 1 seizure/month with alteration of consciousness
- Documented seizure diary, at least 3 months prior to implantation (baseline)
- No change in anti-epileptic drugs 1 month before implantation
- At least one or more AEDs
Key exclusion criteria (5 listed)
- Active cardiac, pulmonary or gastrointestinal disease
- Vagotomy
- Concomitant use of an investigational drug
- Unstable medical condition
- Unstable psychiatric condition
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 paradigm #1Vagus nerve stimulation parameters #1 | Procedure or surgery | 1 |
| Vagus nerve stimulation paradigm #2Vagus nerve stimulation parameters #2 | Procedure or surgery | 2 |
| Vagus nerve stimulation paradigm #3Vagus nerve stimulation parameters #3 | Procedure or surgery | 3 |
Primary outcome
Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type
Time frame: After 6 and 12 months
4 secondary outcomes
VNS-related side effects
Time frame: After 6 and 12 months
Battery life
Time frame: After 6 and 12 months
Quality of life: changes in QOLIE 89 score
Time frame: After 12 months
Mood assessment: changes in Beck depression scale scores
Time frame: After 12 months
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 16 Feb 2023.
- Website of the University Hospital GhentLink provided by the sponsor.
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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.
Paul Boon, MD, PhD principal investigator
University Hospital, Ghent
Vijay Thadani, MD principal investigator
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus nerve stimulation paradigm #1, Vagus nerve stimulation paradigm #2 and Vagus nerve stimulation paradigm #3 in people with Epilepsy, run by University Hospital, Ghent at 2 sites in 2 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 5 inclusion and 5 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 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Belgium. 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?
Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type (time frame: After 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2023.