Trial document



drksid header

  DRKS00003681

Trial Description

start of 1:1-Block title

Title

Transcutaneous Vagus Nerve Stimulation for the treatment of chronic migraine

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

cMPsCMI01

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.klinikum.uni-muenchen.de/Klinik-und-Poliklinik-fuer-Neurologie/de/Klinik/Neurologische_Poliklinik/Kopfschmerz_-_Ambulanz/Studien/index.html

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Invasive vagus nerve stimulation (VNS) is an approved treatment in drug-resistant epilepsy. The development of a medical device to apply transcutaneous vagus nerve stimulation (t-VNS) meets the demand for a non-invasive therapy with low side-effects. During t-VNS electrical pulses are delivered via electrodes which are placed on the skin of the outer ear. A reduction in epileptic seizure frequency is observed both after VNS and after the recently developed t-VNS. Furthermore several clinical case series describe a headache reducing effect of VNS. However, the method is not applied routinely for the treatment of headache at the moment. The study, which is going to begin in the near future, is conducted to elucidate the possible reduction in both the frequency and the intensity of migraine attacks after the application of the medical device. The patient will receive the non-invasive device from the investigator and apply it self-dependently for 4 to maximum 5 hours daily. The prophylactic efficacy of the therapy will be judged using a patient diary. Depending on his participation in the optional follow-up phase the patient will have to participate in 6 to 7 clinical visits during the study phase, which is going to last 4 to 7 months for each participant.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Invasive vagus nerve stimulation (VNS) is an approved treatment in drug-resistant epilepsy. The t-VNS® technology, a non-invasive treatment, uses the fact that the auricular branch of the vagus nerve supplies the cymba conchae of the human ear exclusively. A specifically developed ear electrode guarantees that electrical impulses from the pulse generator, which is connected by cable, can be accurately delivered transcutaneously. The excitatory projection of the cervical and the auricular branches of the vagus nerve to the nucleus of the solitary tract has been shown to activate similar subcortical and cortical areas in the brain. Literature review shows several examples of cases where the invasive VNS seemed to be effective in treating different types of headache. Therefore, the study is going to be conducted in order to demonstrate t-VNS to be an effective option for the treatment of chronic migraine. The influence of t-VNS both on the frequency of migraine attacks and on the intensity of pain during these attacks as well as on the quality of life of patients are the most important outcome parameters of the clinical trial.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003681
  •   2012/03/23
  •   [---]*
  •   no
  •   Approved
  •   510-11, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   CIV-11-09-002381 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   G43.3 -  Complicated migraine
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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.
  •   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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Proof a the therapeutic efficacy of t-VNS for chronic migraine estimated via the number of headache days per 28 days.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Recording of the headache related burden. Recording of the amount of acute medication needed. Recording of the headache intensity. Recording of any adverse events of t-VNS. estimated via: headache intensity during headache days. Consumption of acute medication. Number of migraine related consultations. MIDAS. HIT-6-Score. Mode and number of AEs and SAEs.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/04/17
  •   98
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

males and females from 18 to 70 y. Patients suffering from chronic migraine according to ICHD-II 1.5.1. Duration of disease of minimum 3 months. Prophylactic medication on a stable regimen for minimum 1 month or 5 half-lives (the longer duration will be counted). Stable agent(s) for acute medication during baseline period. Patient diary kept properly for minimum 20 out of 28 days, minimum 15 headache days with minimum 4 hours of headache, extrapolation to 28 days.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Participation in another clinical trial during the last 4 weeks before study entry. Pregnant or breastfeeding women. Suffering from craniomandibular dysfunction or fibromyalgia. Other primary/secondary headache disorders (e.g. cluster headache, trigeminal neuralgia, etc.). Beck depression inventory > 24 at date of inclusion. Other chronic neurological or psychiatric disorders (e.g. psychoses) which impair study participation. Dependance on opioids or benzodiazepines. Anatomical or pathological abnormalities at the left ear. Actual process of retirement.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • cerbomed GmbH
    • Mr.  Dr.  Andreas  Hartlep 
    • Henkestr. 91
    • 91052  Erlangen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • cerbomed gmbH
    • Mr.  Dr.  Andreas  Hartlep 
    • Henkestr. 91
    • 91052  Erlangen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Oberbayerisches Kopfschmerzzentrum der LMU München
    • Ms.  PD Dr. med.  Ruth  Ruscheweyh 
    • Marchioninistr. 15
    • 81377  München
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • cerbomed GmbH
    • Henkestr. 91
    • 91052  Erlangen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/11/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.