EpilepsyNCT01178437
Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy
A study testing T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve) in people with Epilepsy, run by cerbomed GmbH at 1 site in Germany.
Trial summary
The aim of the study is to prove the feasibility and safety of transcutaneous, electrical stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Jan 2011
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written Informed Consent
- Patients of both gender, aged from 18-75 years
- Diagnosis of epilepsy according to the diagnosis criteria of the DSM IV/ ICD 10 (especially G 40.1 /G 40.2/ G 40.3)
- Insufficient response to at least one attempt of treatment in medical history with anticonvulsive medication, dosed sufficiently long and high
- Antiepileptic Drugs (AED) therapy must be stable at a level that promises long-term continuity for at least 10 before study start and has to be continued for at least 3 months during treatment phase
Who cannot join
- Absence of Informed Consent
- Pregnancy
- Psychiatric diseases, especially post-traumatic stress disorder, obsessive-compulsive disorders, schizophrenia, Borderline personality disorders (BPD), character disorders as well as major depressive disorders, anxiety disorders and eating disorders as comorbidity.
- Abuse of drugs and alcohol until 12 weeks before study start
- Cerebrovascular diseases
- Dementia
Show all 19Show fewer
- Severe traumatic brain injury in medical history including invasive and non-invasive methods of therapy (tumor surgery, "Gamma Knife Surgery")
- Indications of structural impairment of the basal ganglia or the brain stem
- active implants (e.g. cochlea implants, VNS, pacemaker)
- Severe neurological diseases (e.g. Morbus Parkinson, systemic neurologic diseases
- severe internistic diseases (e.g. arterial hypertension, respiratory failure)
- Bronchial asthma
- malignant diseases of any kind, within five years before study start
- Severe active infectious diseases (e.g. HIV, hepatitis)
- Bone diseases (e.g. Morbus Paget, recent fractures)
- Diseases of the ENT body system: Hearing loss of the left ear which is treated with a hearing instrument, all dermatologic and infectious diseases which affect the area around the pinna and the ear canal, severe malformation of the pinna
- Vagotomy
- Concurrent participation in other studies
- Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy - a Prospective Pilot Study Regarding Safety, Effectiveness and Clinical Performance
The aim of the study is to prove the feasibility and safety of transcutaneous, electrical stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.
- Conditions
- Epilepsy
- Being tested
- T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)
- Keywords
- seizure disorder,, seizures,, convulsions,, grand mal,, petit mal,, absence seizures,, repeated seizures,, children's seizures,, secondary epilepsy,, symptomatic epilepsy,, generalized seizures,, partial seizure,, focal seizure,, partial complex seizure,, anticonvulsant medication
- Medical subject headings
- Epilepsy, Seizures, Epilepsy, Tonic-Clonic, Epilepsy, Absence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)Device
Also called T-VNS® Stimulator cM02
daily, transcutaneous, electrical stimulation of the vagus nerve by the t-VNS device for a period of 9 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of performance
rated by investigator
QOLIE-89 MADRS CCTE
Measured: 9 months
Secondary outcomes (3)
Patient's subjective assessment of epileptic shocks
rated by patient. Subjective assessment of epileptic shocks and cognitive functions. Measured with "Erlanger Kognitionstest" (EKT)
Measured: 9 months
Further assessment of performance
EEG long-term monitoring, MR spectroscopy
Measured: 9 months
Assessment of Safety
Registration of (S)AEs and drop outs
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startAug 2009
- Primary completionSep 2010
- Study completionJan 2011
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- cerbomed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stefan Herrmann, MD, Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178437
- Sponsor's protocol ID
- cMPsE01
- Status last verified
- Mar 2011
- First submitted
- 29 Jul 2010
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy - a Prospective Pilot Study Regarding Safety, Effectiveness and Clinical Performance
- ClinicalTrials.gov ID
- NCT01178437
- Acronym / sponsor ID
- cMPsE01
- Conditions
- Epilepsy
- Keywords
- seizure disorder,, seizures,, convulsions,, grand mal,, petit mal,, absence seizures,, repeated seizures,, children's seizures,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- cerbomed GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Aug 2010 (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.
The aim of the study is to prove the feasibility and safety of transcutaneous, electrical stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written Informed Consent
- Patients of both gender, aged from 18-75 years
- Diagnosis of epilepsy according to the diagnosis criteria of the DSM IV/ ICD 10 (especially G 40.1 /G 40.2/ G 40.3)
- Insufficient response to at least one attempt of treatment in medical history with anticonvulsive medication, dosed sufficiently long and high
- Antiepileptic Drugs (AED) therapy must be stable at a level that promises long-term continuity for at least 10 before study start and has to be continued for at least 3 months during treatment phase
Key exclusion criteria (19 listed)
- Absence of Informed Consent
- Pregnancy
- Psychiatric diseases, especially post-traumatic stress disorder, obsessive-compulsive disorders, schizophrenia, Borderline personality disorders (BPD), character disorders as well as major depressive disorders, anxiety disorders and eating disorders as comorbidity.
- Abuse of drugs and alcohol until 12 weeks before study start
- Cerebrovascular diseases
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 |
|---|---|---|
| T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)Also: T-VNS® Stimulator cM02daily, transcutaneous, electrical stimulation of the vagus nerve by the t-VNS device for a period of 9 months | Device | – |
Primary outcome
Assessment of performance
Time frame: 9 months
rated by investigator QOLIE-89 MADRS CCTE
3 secondary outcomes
Patient's subjective assessment of epileptic shocks
Time frame: 9 months
Further assessment of performance
Time frame: 9 months
Assessment of Safety
Time frame: 9 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 8 Mar 2011.
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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.
Stefan Herrmann, MD principal investigator
University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve) in people with Epilepsy, run by cerbomed GmbH at 1 site in Germany.
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 19 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 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Assessment of performance (time frame: 9 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 8 Mar 2011.