Trial document




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  DRKS00003148

Trial Description

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Title

deep brain stimulation in patients with refractory epilepsy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients with epilepsy that can not be treated adequately with antiepileptic drugs or resective epilepsy surgery may benefit from deep brain stimulation. Electrical stimulation of circumscribed brain structures aims to significantly reduce frequency and severity of epileptic seizures.
In the current trial, thin electrodes are implanted into subcortical brain structures termed nucleus accumbens and anterior thalamus. These electrodes transmit weak electrical impulses into the brain that are not perceived by the patients. The impulses are generated by a small device that similar to heart pacemakers are implanted below the clavicle. This pacemaker is connected to the intracerebral electrodes via thin subcutaneous electrodes.
The primary aim of the trial is to assess the efficacy of nucleus accumbens stimulation on seizure frequency and severity. For one month after implantation of electrodes, all patients remain unstimulated in order to allow affected brain structures to settle. Following randomisation, in one group of patients the nucleus accumbens is stimulated for the next three months while the other group is unstimulated. After another month, the second group is stimulated for three months while the first group remains unstimulated (cross over-design). In this period of the study, both the patient and the physician do not know at which time points the patient is stimulated. This methodological approach is necessary to assess the placebo effect of electrode implantation and electrical stimulation. After this double-blind study period, all patients are stimulated and parameters of stimulation can be individualised. Depending on previous treatment response to nucleus accumbens stimulation, in this period of the study patients are stimulated in the nucleus accumbens, in the anterior thalamus, or in both structures.
In addition to efficacy of deep brain stimulation, safety and tolerability issues are assessed in detail. At various time points during the trial, neuropsychological and cognitive tests (evaluating memory) as well as quality of life assessments are conducted.
Both brain structures addressed in this trial are involved – as demonstrated in animal studies – in the generation and propagation of epileptic activity. The current trial is the first assessing the effect of electrical stimulation of the nucleus accumbens in patients with difficult-to-treat partial epilepsy. A previous randomised controlled trial in patients with epilepsy (SANTE trial) has demonstrated that stimulation of the anterior thalamus resulted in bisection of seizure frequency. The combination of nucleus accumbens and anterior thalamus stimulation in the second period of the trial hopefully has synergistic effects on seizure frequency and severity.

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Brief Summary in Scientific Language

therapy attempt for patients with refractory epilepsy using chronic deep brain stimulation

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Organizational Data

  •   DRKS00003148
  •   2011/07/04
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  •   yes
  •   Approved
  •   03/08, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

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Health Condition or Problem studied

  •   G40.2 -  Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
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Interventions/Observational Groups

  •  
    3 months baseline
    implantation of deep brain stimulation electrodes
    one month without stimulation
    three months stimulation of ncl. accumbens
    five months without stimulation
    open label period with stimulation of ncl. accumbens, anterior thalamic nucleus or both
  •  
    3 months baseline
    implantation of deep brain stimulation electrodes
    five months without stimulation
    three months stimulation of ncl. accumbens
    one month without stimulation
    open label period with stimulation of ncl. accumbens, anterior thalamic nucleus or both
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Treatment
  •   Crossover
  •   N/A
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Primary Outcome

Fraction of patients with at least 50% reduction of seizure-frequency after three months of deep brain stimulation in comparison with the untreated controls.

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Secondary Outcome

Change of seizure severity assessed with the Liverpool Seizure Severity Scale (assessment: at enrolment, after 3 month, 1 month post-implantation, 4 month post-implantation, 5 month post-implantation, 8 month post-omplantation, 9 month post-implantation, 12 month post-implantation)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/06/20
  •   20
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

pharmaco-refractary partial epilepsy with at least three disabling seizures in four week during the past three months

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Exclusion Criteria

psychiatric and/or internal relevant comorbidity, psychogenic non-epileptic seizures, progressive degenerative neurological disease, custodial guardianship

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Addresses

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    • Universitätsklinik für Stereotaktische Neurochirurgie des Universitätsklinikums Magdeburg AöR
    • Mr.  Prof.  Jürgen  Voges 
    • Leipziger Str 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Stereotaktische Neurochirurgie des Universitätsklinikums Magdeburg AöR
    • Mr.  Prof.  Jürgen  Voges 
    • Leipziger Str 44
    • 39120  Magdeburg
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Mr.  Dr. med.  Alexander  Kowski 
    • Augustenburger Platz 1
    • 13353   Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Stereotaktische Neurochirurgie des Universitätsklinikums Magdeburg AöR
    • Mr.  Prof.  Jürgen  Voges 
    • Leipziger Str 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.