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

NCT01178437 | Completed

• 1 other identifier: cMPsE01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy

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

Outcome Measures

Primary Outcomes (1)

• Assessment of performance

  rated by investigator QOLIE-89 MADRS CCTE

  9 months

Secondary Outcomes (3)

• Patient's subjective assessment of epileptic shocks

  9 months

• Further assessment of performance

  9 months

• Assessment of Safety

  9 months

Interventions

T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve) DEVICE

daily, transcutaneous, electrical stimulation of the vagus nerve by the t-VNS device for a period of 9 months

Also known as: T-VNS® Stimulator cM02

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• cerbomed GmbH: lead

Study Sites (1)

Epilepsiezentrum Erlangen

Erlangen, Bavaria, 91054, Germany

Location

MeSH Terms

Conditions

Epilepsy; Seizures; Epilepsy, Tonic-Clonic; Epilepsy, Absence

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Epilepsy, Generalized; Epileptic Syndromes

Study Officials

• Stefan Herrmann, MD

  University of Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 10, 2010
• Study Start: August 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: January 1, 2011
• Last Updated: March 8, 2011

Record last verified: 2011-03

Locations

DE (1)