Deep Brain Stimulation (DBS)

of the Globus Pallidus (GP) in Huntington’s Disease (HD) (HD-DBS)

Active, not recruiting

ABOUT

SPONSOR

Heinrich-Heine University, Duesseldorf

PARTICIPANTS

50

The main purpose of this study is to investigate whether Deep Brain stimulation has a positive effect on the motor and cognitive symptoms in Huntingtons patients. Deep brain stimulation (DBS) is a surgery to implant a device that sends electrical signals to brain areas responsible for body movement. Electrodes are placed deep in the brain and are connected to a stimulator device. Similar to a heart pacemaker, a neurostimulator uses electric pulses to regulate brain activity. DBS treatment has been used for some people with Parkinsons disease. Both safety and efficacy will be investigated in this study with 50 participants. 25 participants will be stimulated with the DBS for the first period of 3 months and their performance on a variety of tests, will be compared with the 25 participants who don’t get any stimulation. After the first 3 months, all participants will be treated with DBS for another 3 months.

Estimated Study Completion Date: 31 December, 2022

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

COUNTRIES

AUSTRIA

TRIAL SITE:
Medizinische Universität Innsbruck

Address: Innsbruck, Austria, 6020

CONTACT
Klaus Seppi
Tel: + 43 (0)512 504-25810
klaus.seppi@tirol-kliniken.at

Marina Peball
Tel: +43 512 504/82718
marina.peball@tirol-kliniken.at

Recruiting

FRANCE

TRIAL SITE:
CHU Amiens Hôpital nord, Department of neurosurgery and Department of neurology

Address: Amiens, France, 80054

CONTACT
Pierre Krystkowiak  
Tel.: +33322668240
krystkowiak.pierre@chu-amiens.fr   

Michel Lefranc
Lefranc.Michel@chu-amiens.fr  

Recruiting

TRIAL SITE: 
Hôpital Roger Salengro, Service de Neurologie et Pathologie du mouvement

Address: Lille Cedex, France, 59037

CONTACT

Clemence Simonin
Tel: +33 3.20.44.67.52
clemence.simonin@chru-lille.fr

Eric Decorte
Tel.: +33 03.20.44.59.62
eric.decorte@chru-lille.fr  

Recruiting

GERMANY

TRIAL SITE:
kbo-Isar-Amper-Klinikum Taufkirchen

Address: Taufkirchen, Germany, 84416

CONTACT
Michael Bachmaier   
Tel: +49 (0)808 493 4417   
michael.bachmaier@kbo.de

Ralf Marquard
Tel: 08084 934 495
Ralf.Marquard@kbo.de   

Recruiting

TRIAL SITE:
University Hospital Schleswig-Holstein

Address: Kiel, Germany, 24105

CONTACT
Steffen Paschen
Tel: 0431-500-23842    Steffen.Paschen@uksh.de

Birte Hackelberg   
Tel: 0431-597 8519    birte.hackelberg@uksh.de

Recruiting

TRIAL SITE:
Universität zu Lübeck

Address: Lubeck Hansestadt, Germany, 23562

CONTACT
Alexander Münchau
Tel: 0451 31018215    alexander.muenchau@neuro.uni-luebeck.de

Vera Tadic   
Tel: 0451 31018214    vera.tadic@neuro.uni-luebeck.de

Recruiting

TRIAL SITE:
University hospital Munich LMU

Address: Munich, Germany, 80336

CONTACT
Jan Mehrkens
Tel: 08970952698    jan.mehrkens@med.uni-muenchen.de

Kai Bötzel
Tel: 089 7095 3673    Kai.Boetzel@med.uni-muenchen.de

Recruiting

TRIAL SITE:
University Hospital Schleswig-Holstein

Address: Kiel, Germany, 24105

CONTACT
Steffen Paschen
Tel: 0431-500-23842    Steffen.Paschen@uksh.de

Birte Hackelberg   
Tel: 0431-597 8519    birte.hackelberg@uksh.de

 

Recruiting

TRIAL SITE:
University Hospital Freiburg

Address: Freiburg, Germany, 79106

CONTACT

Volker Coenen
Tel: +4976127050630   

volker.coenen@uniklinik-freiburg.de

Eva Maria Wissner

Tel: +49 761 270-50670
eva-maria.wissner@uniklinik-freiburg.de

 

Recruiting

TRIAL SITE:
University hospital Heinrich Heine University Düsseldorf

Address:Düsseldorf, Germany, 40225

CONTACT
Jan Vesper
Tel: +49 211 81 18408    jan.vesper@med.uni-duesseldorf.de

Alfons Schnitzler
Tel: +49 211 81 17893    Schnitza@med.uni-duesseldorf.de

Recruiting

TRIAL SITE:
Charité Campus Virchow Klinikum

Address: Berlin, Germany, 13353

CONTACT
Andrea Kühn
Tel: 030 450 660203    andrea.kuehn@charite.de

Mandy Schickor   
Tel: +49 (0)30 450 660 478    Mandy.Schickor@charite.de

 

Recruiting

SWITZERLAND

TRIAL SITE:
Center for Neurology

Address: Bern, Gümlingen, Switzerland, 3073

CONTACT
Jean Marc Burgunder
Tel: +41 031 352 20 70   
jean-marc.burgunder@dkf.unibe.ch

Michael Schüpbach
Tel: +41 316322168    wmms@bluewin.ch

Recruiting