Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003221

Trial Description

start of 1:1-Block title

Title

Ethical, social and legal aspects of patients with deep brain stimulation

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

Trial Acronym

ELSA-DBS

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

Aim of the study is to investigate in how far deep brain stimulation influences the life of patients and caregivers. On the basis of our research we plan to discover psychosocial problems of patients with deep brain stimulation. Past studies showed that deep brain stimulation leads to an improvement of motor symptoms in patients with parkinson's disease and dystonia. However, impairments of cognitive functions, including verbal fluency and psychosocial well-being, are also observed. We want to examine, if and in which way a change of non-motor symptoms, like for instance in quality of life and social interactions,occurs after deep brain stimulation. Additionally to the patient's perception of deep brain stimulation, we want to observe the caregiver's view of the treatment procedure.

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

Brief Summary in Scientific Language

Many patients with parkinson's disease and generalized dystonia are treated with deep brain stimulation. Results of amelioration of motoric functions are impressive. ELSA-DBS investigates the influence of deep brain stimulation of these patients on quality of life, personal identity, and social interactions. The neurological project (part 1) investigates the influence of parkinson's disease patients and patients with dystonia and their relatives.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003221
  •   2011/08/29
  •   [---]*
  •   yes
  •   Approved
  •   09-064, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   G20 -  Parkinson's disease
  •   G24 -  Dystonia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   patients with parkinson's disease are interviewed and tested with questionnaires on four defined time points
  •   patients with dystonia are interviewed and tested with questionnaires on four defined time points
  •   caregivers are interviewed and tested with questionnaires on four defined time points
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

the comparison of the preoperative and 12 months postoperative measurement of subjective quality of life in patients and caregivers measured by parkinson's disease questionnaire 39

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

Secondary Outcome

Furthermore cognition, personality, social functioning, motor performance and mood were assessed: Beck depression inventory (BDI-2), Apathy evaluation scale (AES), Unified parkinson's disease reating scale part 3 (UPDRS-III), Social and Occupational Functioning Assessment Scale (SOFAS), brief test of attention (BTA), five-factor model of personality (NEO-FFI), semi-structured interview; time for exploration: pre-operatively, 1 week, 3 months and 12 months after implantation

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

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2009/11/15
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Inclusion criteria of patients
- patients with clinical diagnosis of idiopathic parkinson' disease or dystonia
- patients, who with obtained deep brain stimulation
- patients in the age between 30 and 80 with German as nature language
- patients with a mini mental status test with at least 25 points
- capability to agree and with a capibility to sign the written consent
Inclusion criteria of caregivers
- caregivers betweeen 30 and 80 with German as native language
- Caregivers with mini mental status test with at least 25 points
- Caregivers with the capability to agree and with a capibility to sign the written consent


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

Exclusion Criteria

Exclusion criteria of patients
- patients,who suffer on a different deterioation of cognition ( vascular disease, tumor, e.t.c.)
- patients, who suffer from an active psychiatric disorder
- patients, who take part in other studies, which could interfer with the exsitent study and whereby the partitipants could be endangered or especially be stressed or if the results of the study could be tampered
- patients, who do not agree to the interview of the caregivers

Exclusion criteria of caregivers
- caregivers who suffer parkinson's disease and dystonia themselfs
- caregivers, who suffer on a different deterioation of cognition ( vascular disease, tumor, e.t.c.)
- caregivers, who suffer from an active psychiatric disorder

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Fakultät der Universität zu Köln vertreten durch Herrn Univ.-Prof. Dr. Lars Timmermann
    • Joseph-Stelzmann-Str. 24
    • 50924  Köln
    • 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
    • Universitätsklinikum Köln
    • Mr.  Univ.-Prof. Dr. med.  Lars  Timmermann 
    • Kerpener Str. 62
    • 50924  Köln
    • 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
    • Universitätsklinikum Köln
    • Ms.  Franziska  Maier 
    • Kerpener Str. 62
    • 50924  Köln
    • 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
    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • 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 continuing
  •   [---]*
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.