A randomized, controlled, double-blind, two-arm clinical trial to assess safety and efficacy of transcutaneous vagus nerve stimulation (t-VNS®) in patients with drug-resistant epilepsy

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00003689
• Date of registration: 02/04/2012
• Prospective Registration: Yes
• Primary sponsor: cerbomed GmbH
• Public title: A randomized, controlled, double-blind, two-arm clinical trial to assess safety and efficacy of transcutaneous vagus nerve stimulation (t-VNS®) in patients with drug-resistant epilepsy
• Scientific title: A randomized, controlled, double-blind, two-arm clinical trial to assess safety and efficacy of transcutaneous vagus nerve stimulation (t-VNS®) in patients with drug-resistant epilepsy - cMPsE02
• Date of first enrolment: 23/05/2012
• Target sample size: 70
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00003689
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Austria, Germany

Contacts

• Name: Andreas Hartlep
• Affiliation: cerbomed gmbH

• Name: Andreas Harlep
• Affiliation: cerbomed

Key inclusion & exclusion criteria

Inclusion criteria: To be eligible for inclusion into this study, the patient must fulfill all of the following criteria prior to enrollment:
Males or females = 18 and = 65 years of age.
Must be able to consent to participation by signing the informed consent form.
Has any of a broad range of epilepsy syndromes (e.g. with simple or complex partial or primary or secondary generalized seizures).
Has = 3 seizures per month and not more than 21 days between seizures, both prior to screening (assessed retrospectively) and during the baseline period.
Is on a stable regimen of = 3 antiepileptic drugs (AEDs), has been on this regimen for at least 5 weeks prior to study enrollment, and maintains this regimen throughout the participation in the study.

Exclusion criteria: To be eligible for inclusion into this study, the patient must not meet any of the following criteria prior to enrollment
Is participating in another clinical study at the time of this study, or has participated in another study within 30 days prior to signing the informed consent form.
Is pregnant or breast-feeding.
Is a sexually active female of child-bearing potential unless she is using a reliable, medically-approved primary-form of birth control. At the discretion of the investigator, total abstinence from sexual intercourse is acceptable in those cases where the age, career, lifestyle or sexual orientation of the patient ensures the prevention of a pregnancy.
Is an employee of the investigational site directly affiliated with this study and/or their immediate family members, an employee of the sponsor or the clinical research organization.
Is unwilling or unable to adhere to all study requirements, including accurate completion of the patient diary and questionnaires at the required time points and attending all study visits.
Is unable to understand the study plan, its conditions, the therapy goals and expected outcomes.
Has a substance use disorder (DSM-IV).
Has a major psychiatric disorder (Diagnostic and Statistics Manual of Mental Disorders), such as major depressive disorder or schizophrenia.
Has a deteriorating neurological or medical condition, including for example cerebrovascular degeneration or structural damage to basal ganglia.
Has any relevant cardiac disease, asthma, AIDS or HIV-infection or previous or current diagnosis of any form of cancer other than basal cell carcinoma.
Is using more than 3 AEDs at the time of study enrollment or at randomization.
Has a history of non-epileptic seizures.
Has had more than 1 episode of status epilepticus in the 6 months prior to study enrollment.
Has or has had invasive VNS or deep brain stimulation.
Has undergone ablative epilepsy surgery.
Has undergone cervical vagotomy.
Has a skin pathology or disease such as an infection, psoriasis, or eczema in the treatment area.
Has any anatomical pathology or other limitation that would prevent successful placement of the device.
Has an active implantable medical device such as a cardiac pacemaker, defibrillator, neurostimulator, cochlear implant, or active drug administration device.
Has any other serious medical condition that could adversely affect their participation in the study.


Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

G40

Epilepsy

Intervention(s)

Group 1: active group: transcutaneous, non-invasive electrical stimulation of the auricular branch of the vagus nerve by using a specific ear
electrode. A cable connects this ear electrode with the stimulation unit, which has the size of a mobile phone. In the active arm impulses will be
given in a high frequency for 4 up to a maximum of 5 hours daily and a period of 20 weeks in total.
Group 2: active control group: Stimulation with the same kind of medical device and at the same site as done in the active group, but with a lower
impulse ferquency for 4 up to a maximum of 5 hours daily and a period of 20 weeks in total.

Primary Outcome(s)

To evaluate the efficacy of add-on therapy with high-level t-VNS® in comparison to add-on therapy with low-level t-VNS® at reducing seizure-frequency per 28 days in patients with drug-resistant epilepsy, as measured by the change in mean seizure-frequency per 28 days from baseline to the last 28 days of the treatment phase

Secondary Outcome(s)

To evaluate the safety of add-on therapy with high-level t-VNS® in comparison to add-on therapy with low-level t-VNS® in patients with drug-resistant epilepsy, the frequency, severity, nature and duration of adverse events will be assessed, and changes from baseline in physical exam results and vital signs between the two treatment groups will be compared.
To evaluate the change in seizure-frequency per 28 days from baseline to the treatment period within each group.
To determine the percentage of patients in each treatment group who experience a 25% reduction in seizure-frequency (change from baseline to last 28 days of treatment).
To determine the percentage of patients in each treatment group who experience a 50% reduction in seizure-frequency (change from baseline to last 28 days of treatment).
To evaluate changes in seizure severity in each group from baseline to the last 28 days of treatment.
Via QoLiE-31P, to evaluate changes in the impact of epilepsy on the patients’ quality of life from baseline to the last 28 days of treatment.
Exploratory: To gather information on the ability of treatment with high-level t-VNS® to inhibit the full development of impending seizures.
To gather information on the epilepsy-related use of health-care services by patients with drug-resistant epilepsy.
To gather information on school/work time missed due to epilepsy.
To gather cost-effectiveness data/ data on resource utilization.

Source(s) of Monetary Support

cerbomed GmbH

Ethics review

Status: Approved
Approval date: 16/02/2012
Contact:

[e-mail]

Ethik-Kommission der Medizinischen Fakultät der Universität Erlangen-Nürnberg

[phone]

[e-mail]

Results

• Date Completed: 26/08/2014
• URL: http://drks.de/search/en/trial/DRKS00003689#studyResults