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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00003221
Enrollment
50
Registered
2011-08-29
Start date
2009-11-15
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G20 G24

Interventions

Group 1: patients with parkinson's disease are interviewed and tested with questionnaires on four defined time points Group 2: patients with dystonia are interviewed and tested with questionnaires on

Sponsors

Medizinische Fakultät der Universität zu Köln vertreten durch Herrn Univ.-Prof. Dr. Lars Timmermann
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Germany

Contacts

Public ContactFranziska Maier

Universitätsklinikum Köln

franziska.maier@uk-koeln.de0221-478-86180

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 23, 2026