Trial document




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  DRKS00006766

Trial Description

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Title

Effects of stimulation in the nucleus accumbens on motivational and cognitive processes of patients with chronic alcohol dependence

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Trial Acronym

ESNachA

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URL of the Trial

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Brief Summary in Lay Language

Patients who are alcoholics get a new therapy, because the have known not helpful. It is applied an operating method where electrodes are implanted. These stimulate the addiction center in the brain. This electrical stimulation, the activity changes in this area. This should disappear in the long term addiction.
By coincidence, the stimulator is in half of all study participants switched off after three months. After another three months, this is finally and permanently activated. The other half of the study participants is first turned three months then activated for the next three months. This group will remain on permanently even after the expiry of six months. Doctor and patient do not know which patient is assigned to which group.

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Brief Summary in Scientific Language

We have conducted in the past two years in five patients with refractory alcohol addiction a therapeutic trial with THS in Nacc , which has led to a massive reduction in relapse frequency and in two cases to total abstinence This approach is based on the idea that alcoholism is a special form of obsessive-compulsive disorder , and that with treatment-resistant obsessive-compulsive disorder , the high-frequency DBS can achieve a significant clinical improvement in the shell of Nacc ; Moreover, it was observed by another research group in a patient as an incidental finding , a reduction of his alcohol addiction among Nacc stimulation.

While these results are encouraging, but need for a confirmation , on the other hand a thorough scientific investigation. For if the desired stimulation effect can confirm , it follows that motivation and motivated action of these patients be influenced. We can not judge whether and to what extent these effects selectively affect addictive behavior currently , however ; possibly the intensity and breadth motivational behavior are generally in the long run stimulation changed with potentially significant consequences.
The planned in the clinical trial cognitive experiments therefore focused on the effect of stimulation of the Nacc on motivational and cognitive processes.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006766
  •   2016/08/09
  •   2014/09/16
  •   yes
  •   Approved
  •   09/11, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1161-8388 
  •   00006631  (DIMDI-Registriernummer)
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Health Condition or Problem studied

  •   chronic alcohol dependence
  •   F10.2 -  Mental and behavioural disorders due to use of alcohol; Dependence syndrome
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Interventions/Observational Groups

  •   Implantation of the stimulation electrode

    Intervention phase:
    12 weeks with activated stimulation electrode
    12 weeks with switched off stimulation electrode

    From week 25 permanent activation of the stimulation electrode
  •   Implantation of the stimulation electrode

    Intervention phase:
    12 weeks with switched off stimulation electrode
    12 weeks with activated stimulation electrode

    From week 25 permanent activation of the stimulation electrode
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoint: relapse of alcohol abuse (patient interviews)
first evaluation
12 weeks after activation: new evaluation; after conversion of the stimulation
24 weeks after activated stimulation: new evaluation
1 year after activated stimulation: new evaluation
2 years after activated stimulation: new evaluation

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Secondary Outcome

Secondary endpoint: Improvement of cognitive memory function
What are the effects of stimulation in the nucleus accumbens on motivational and cognitive processes of patients with chronic alcohol dependence? implementation of following tests: Psychometric testing 3 , 6 and 12 months after implantation : • VLMT - Verbal Learning Test ( using different parallel forms ) • D2 - concentration test • sense memory ( retell stories parallel form ) • I STAI - State Trait Anxiety Inventory (State ) • BDI II - Beck Depression Inventory • LDH - Lifetime Drinking History • SVF - coping questionnaire • I-SEE- Inventory for the Measurement of Self-Efficacy and Externality• Urica - University of Rhode Island Change Assessment ( questionnaire for the assessment of treatment motivation ) • ADS - Alcohol Dependence Scale • AUQ - Alcohol Urge Questionnaire • Fagerström - Test for Nicotine Dependence • CGI - Clinical Global Impression • OCDS - Obsessive Compulsive Drinking Scale • ACQ - Alcohol Craving Questionnaire

In addition, the 12 - month follow-up : • SCID- II - Structured Clinical Interview for DSM - IV • HAWIE - Hamburg - Wechsler Intelligence Test for Adults
first evaluation
12 weeks after activation: new evaluation; after conversion of the stimulation
24 weeks after activated stimulation: new evaluation
1 year from activated stimulation: new evaluation
2 years from activated stimulation: new evaluation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/10/01
  •   15
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

1. Alcoholabusus ICD-10 and DSM-IV
2 Male and female individuals 18-65 years of age
3. No alcohol at least 10 days after completion of detoxification
4 Since 4 weeks no sedative drugs (benzodiazepines, clomethiazole)
5. Therapies without lasting success: including medical detoxification, inpatient or partial inpatient long-term treatment ≤ 8 weeks psychotherapies
6. Relapse prevention medication (acamprosate, naltrexone, disulfiram or other)
7. Therapies must be documented
8. in last 12 months about 6 months "drinking days"
9. Patients are mentally competent, willing and able to sign
10. Patients must have sufficient knowledge of German


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Exclusion Criteria

1. medical history cerebral seizures except by alcohol withdrawal
2. severe neurological or internal medical comorbidity
3. coagulopathy
4. other acute, severe, requiring treatment psychiatric disorders of Axis I (according to criteria of DSM IV)
5. personality disorder according SCID-II
6. cardiac or pulmonary disease with risk of anesthesia (ASA value> 3)
7. participation in other clinical studies 30 days before inclusion
8. medical history of significant brain vascular malformations, head injury or neurosurgical operations
9. cerebral changes in current CT / MRI
10. pacemaker or an implantable defibrillator
11. possible need an MRI scan after inclusion in the study
12. pregnancy or lactation or women wishing to become pregnant
13. planned inpatient or partial inpatient long-term therapy
14. mental retardation (HAWIE IQ <70)
15. legal care or patient of a psychiatric facility
16. medical history drug use (current drug abuse) or drug addiction (past drug dependence) - except nicotine.

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Addresses

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    • Otto-von-Guericke-Universität MagdeburgMedizinische Fakultät, Klinik für Stereotaktie
    • Mr.  Prof.   Hermann-Josef Rothkötter 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Klinik für Stereotaktische Neurochirurgie
    • Mr.  Prof. Dr. med  Jürgen  Voges 
    • Leipziger Str.44
    • 39120  Magdeburg
    • Germany
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    • Klinik für Stereotaktische Neurochirurgie
    • Ms.  Martina  Leucke 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2017/01/16
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Trial Publications, Results and other Documents

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