HD-DBS- At a Glance
  • Sponsored by:  Heinrich-Heine University, Duesseldorf
  • Collaborators: KKS Netzwerk, Medtronic, The George Institute, EHDN and CHDI Foundation, Inc.
  • Official title: Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington’s Disease (HD) (HD-DBS)
  • Involves:  Implantation of the ACTIVA® PC neurostimulator (Model 37601)
  • Study type: Clinical Interventional trial
  • Purpose: In this study the efficacy and safety of pallidal Deep Brain Stimulation (DBS) in HD patients shall be investigated and superiority of DBS on motor function in the stimulation group compared to the stimulation-off group shall be shown. This study is a prospective, randomised, double blind, parallel group, sham-controlled, multi-centre trial. Patients in the stimulation group will be stimulated for three months while the stimulator in the sham-group will be turned off for three months. After three months the primary endpoint will be assessed. Afterwards the stimulator will be turned on in all patients.
  • Status: see trial sites below for details on recruitment status
Eligibility Criteria

Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:  All
Accepts Healthy Volunteers:  No

 

 

Inclusion Criteria

  • Clinically symptomatic and genetically confirmed HD (number of CAG repeats ≥ 36)
  • Age ≥18 years
  • Moderate stage of the disease (UHDRS motor score ≥ 30)
  • Chorea despite best medical treatment (UHDRS chorea subscore ≥ 10)
  • Mattis Dementia Rating Scale ≥ 120 (or > 80% of items testable independently from motor impairment)
  • Patient has stable medication prior six weeks before inclusion
  • Signed informed consent

Exclusion Criteria

  • Juvenile HD (Westphal variant) or predominant bradykinesia
  • Postural instability with UHDRS retropulsion score > 2
  • Severe comorbidity compromising operability and/or life expectancy and/or quality of life during the trial duration (e.g. cancer with life expectancy < 6 months, NYHA 3 and 4 rising the anaesthetic risk according to the anaesthesiologist)
  • Acute suicidality
  • Acute psychosis (symptoms within previous 6 months)
  • Participation in any interventional clinical trial within 2 months before screening
  • Cortical atrophy grade 3
  • Patients with risk of coagulopathies and/or increased risk of haemorrhage
  • Patients with an implanted pacemaker or defibrillator
  • Pregnancy
  • lactation

 

TRIAL SITES

 

AUSTRIA

 

Trial site:  Medizinische Universität Innsbruck   Status: Recruiting
Address: Innsbruck, Austria, 6020    
Contact: Klaus Seppi, Prof Dr

Contact: Marina Peball, Dr.

 

Telephone: + 43 (0)512 504 25810

Telephone: +43 (0)512 504 82718

 

Email: klaus.seppi@tirol-kliniken.at

Email: marina.peball@tirol-kliniken.at 

 

 

 

FRANCE

 

Trial site: CHU Amiens Hôpital nord, Department of neurosurgery and Department of neurology   Status: Recruiting
Address: Amiens, France, 80054    
Contact: Pierre Krystkowiak, Prof

Contact: Michel Lefranc, Dr

 

Telephone: +33 322 668 240

Telephone: Not available

 

Email: krystkowiak.pierre@chu-amiens.fr  

Email: Lefranc.Michel@chu-amiens.fr  

 

 

 

 

Trial site:  Hôpital Roger Salengro, Service de Neurologie et Pathologie du mouvement   Status: Recruiting
Address: Lille Cedex, France, 59037    
Contact: Clemence Simonin, Dr.

Contact: Eric Decorte

 

Telephone: +33 320 446 752   

Telephone: +33 320 445 962    

 

Email: clemence.simonin@chru-lille.fr  

Email: eric.decorte@chru-lille.fr

 

 

GERMANY

 

Trial site:  Charité Campus Virchow Klinikum   Status: Recruiting
Address: Berlin, Germany, 13353    
Contact: Andrea Kühn, Prof Dr

Contact: Mandy Schickor

 

Telephone: +49 (0)30 450 660203

Telephone: +49 (0)30 450 660 478

 

Email: andrea.kuehn@charite.de

Email: Mandy.Schickor@charite.de  

 

 

 

 

Trial site:  University hospital Heinrich Heine University Düsseldorf   Status:Recruiting

Address: Düsseldorf, Germany, 40225    
Contact: Jan Vesper, Prof Dr.

Contact: Alfons Schnitzler, Prof Dr.

 

Telephone: +49 211 81 18408

Telephone: +49 211 81 17893

 

Email: jan.vesper@med.uni-duesseldorf.de

Email: Schnitza@med.uni-duesseldorf.de

 

 

 

Trial site:  University Hospital Freiburg   Status: Recruiting
Address: Freiburg, Germany, 79106    
Contact: Volker Coenen, Prof Dr .

Contact: Eva Maria Wissner

 

Telephone: +49 761 270 506 30

Telephone: +49 761 270 506 70

 

Email: volker.coenen@uniklinik-freiburg.de

Email: eva-maria.wissner@uniklinik-freiburg.de

 

 

 

Trial site: University Hospital Schleswig-Holstein   Status: Recruiting
Address: Kiel, Germany, 24105    
Contact: Steffen Paschen,Dr

Contact: Birte Hackelberg

 

Telephone: 0431 500 238 42

Telephone:  0431 597 851 9

 

Email: Steffen.Paschen@uksh.de

Email: birte.hackelberg@uksh.de

 

 

 

 

Trial site: Universität zu Lübeck   Status: Recruiting
Address: Lubeck Hansestadt, Germany, 23562    
Contact: Alexander Münchau, Prof Dr.

Contact: Vera Tadic

 

Telephone: + 45 131 018 215

Telephone:  +45 131 018 214

 

Email: alexander.muenchau@neuro.uni-luebeck.de

Email:  vera.tadic@neuro.uni-luebeck.de

 

 

 

 

Trial site:  University hospital Munich LMU   Status: Recruiting
Address: Munich, Germany, 80336    
Contact: Jan Mehrkens, Dr

Contact: Kai Bötzel, PD Dr

 

Telephone: 08970952698

Telephone: 089 7095 3673

 

Email: jan.mehrkens@med.uni-muenchen.de

Email: Kai.Boetzel@med.uni-muenchen.de

 

 

 

 

Trial site: kbo-Isar-Amper-Clinic Taufkirchen   Status: Recruiting
Address: Taufkirchen, Germany, 84416    
Contact: Ralf Marquard, Prof Dr

Contact: Michael Bachmeier

 

Telephone: 080 84 934 495

Telephone: 080 84934417

 

Email: Ralf.Marquard@kbo.de

Email: michael.bachmaier@kbo.de

 

 

 

SWITZERLAND

 

Trial site: Center for Neurology   Status:  Recruiting
Address: Bern, Gümlingen, Switzerland, 3073

   
Contact: Jean Marc Burgunder, Prof Dr

Contact: Michael Schüpbach

 

Telephone: +41 031 352 20 70

Telephone: +41 316322168

 

Email:  jean-marc.burgunder@dkf.unibe.ch

Email: wmms@bluewin.ch   

 

 

 

 

Trial site: Inselspital, Department of Neurology   Status: Recruiting
Address:  Bern, Switzerland, 3010    
Contact: Michael Schüpbach, PD Dr

Contact: Jean Marc Brugunder, Prof Dr.

 

Telephone: +41 31 623 32 44

Telephone: +41 031 352 20 70

 

Email:  wmms@bluewin.ch

Email:  jmburgunder@bluewin.ch