Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178437
• Other study ID #: cMPsE01
• Status: Completed
• Phase: N/A
• First received: July 29, 2010
• Last updated: March 7, 2011
• Start date: August 2009
• Est. completion date: January 2011

Study information

• Verified date: March 2011
• Source: cerbomed GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)
daily, transcutaneous, electrical stimulation of the vagus nerve by the t-VNS device for a period of 9 months

Locations

Country	Name	City	State
Germany	Epilepsiezentrum Erlangen	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
cerbomed GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of performance	rated by investigator; QOLIE-89 MADRS CCTE	9 months	No
Secondary	Patient's subjective assessment of epileptic shocks	rated by patient. Subjective assessment of epileptic shocks and cognitive functions. Measured with "Erlanger Kognitionstest" (EKT)	9 months	No
Secondary	Further assessment of performance	EEG long-term monitoring, MR spectroscopy	9 months	No
Secondary	Assessment of Safety	Registration of (S)AEs and drop outs	9 months	Yes