Trial Description. DRKS-ID: DRKS Date of Registration in DRKS: 2013/07/09. PLEASE NOTE: This trial has been registered retrospectively.

Transcription

1 PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title Prospective, controlled study of deep brain stimulation (DBS) in the region of the posterior subthalamic area (PSA) with a randomized, double-blinded, cross-over comparison between PSA- and nucleus ventralis intermedius (VIM)-DBS for the treatment of essential tremor (ET). Trial Acronym PSA-VIM URL of the trial [---]* Brief Summary in Lay Language The Aim of this study is the clarification where the best location for electrode placement in essential tremor patients treated with deep brain stimulation is located. Patients suffering from medication refractory essential tremor can participate in the study. Deep brain stimulation in the region of the thalamus is considered as an effective and safe surgical therapy for the symptomatic treatment of essential tremor, when treatment with medication is insufficient. During the last years, more and more references in the literature have shown that stimulation below the thalamus, leads to the same or an even better tremor reduction in essential tremor patients. The aim of this study is i.) the first-time investigation of the tremor reduction through deep brain stimulation of the area below thalamus in a controlled, prospective study and ii.) the comparison between stimulation in the thalamus und in the area below thalamus concerning their effect on tremor reduction, with special emphasis on treatment effect, possible side effects and the resulting quality of life. Brief Summary in Scientific Language Deep brain stimulation (DBS) in the region of the nucleus ventralis intermedius (VIM) is considered an effective and safe surgical therapy for the symptomatic treatment of essential tremor (ET), when treatment with medication is insufficient. During the last years, more and more references in the literature have shown that stimulation below the VIM, in the so called posterior subthalamic area (PSA), leads to the same or an even better tremor reduction in ET patients. The aim of this study is i.) the first-time investigation of the tremor reduction through DBS of the PSA in a controlled, prospective study and ii.) the comparison between VIM- and PSA-stimulation concerning their effect on tremor reduction, with special emphasis on treatment effect, possible side effects and the resulting Page 1 of 6

2 quality of life. Organizational Data DRKS-ID: DRKS Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: , Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln Secondary IDs Health condition or Problem studied ICD10: G Essential tremor Interventions/Observational Groups Arm 1: VIM stimulation (deep brain stimulation in nucleus ventralis intermedius ) Arm 2: PSA stimulation (deep brain stimulation in posterior subthalamic area) Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: [---]* Who is blinded: patient/subject, investigator/therapist Control: Active control (effective treament of control group) Purpose: Treatment Assignment: Crossover Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Page 2 of 6

3 Primary Outcome Reduction of the Fahn Tremor Rating Scale (FTRS) at 3, 5 and 7 months after implantation and stimulation by PSA-DBS com-pared to baseline Please note: Amendment from regarding the timepoint of Assesment of primary Endpoint. Approved by the Ethics Commitee. Secondary Outcome - Baseline vs. 3, 5 and 7 MFU Key secondary endpoint(s) PSA-DBS: oimprovement of Quality of Life (SF-36, QUEST) odepression (BDI-II) oataxia rating Scale (ICARS) ovisual analogue scales tremor/dysarthria/gait/general (physician) ovisual analogue scales tremor/dysarthria/gait/general (patient) Countries of recruitment DE Locations of Recruitment University Medical Center Klinik und Poliklinik für Neurologie, Köln Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2013/01/10 Target Sample Size: 15 Page 3 of 6

4 Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2013/01/10 Target Sample Size: 15 Monocenter/Multicenter trial: Monocenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: 18 Years Maximum Age: 90 Years Additional Inclusion Criteria i.) confirmed diagnosis of ET according to the Movement Disorder Society (MDS) consensus diagnostic criteria for ET ii.) >18 years of age, iii.) sufficient competence in the German language, iv.) at least two medication attempts without satisfactory tremor control, and v.) capability of informed consent. Exclusion criteria i.) clinically relevant dementia that might interfere with the study, ii.) clinically relevant psychiatric disorder that might interfere with the study, Addresses Primary Sponsor Uniklinik Köln, Neurologie, Page 4 of 6

5 Primary Sponsor Uniklinik Köln, Neurologie, Fax: [---]* [---]* Contact for Scientific Queries Universität zu Köln Mr. Dr. Michael Barbe Telephone: Fax: michael.barbe at uk-koeln.de Contact for Public Queries Universität zu Köln Neurologie Ms. Alin Milke Telephone: Fax: kerstin.donner at uk-koeln.de Sources of Monetary or Material Support Institutional budget, no external funding (budget of sponsor/pi) Uniklinik Köln Kerpener Strasse Köln Fax: [---]* Page 5 of 6

6 Institutional budget, no external funding (budget of sponsor/pi) Uniklinik Köln Kerpener Strasse Köln Fax: [---]* [---]* Status Recruitment Status: Recruiting complete, follow-up continuing Study Closing (LPLV): [---]* Trial Publications, Results and other documents * This entry means the parameter is not applicable or has not been set. Page 6 of 6