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Completed

NCT Number: NCT02535884

Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD)

The aim of the study is to prove the efficacy and safety of pallidal DBS in HD patients and to show superiority of DBS on motor function in the stimulation group compared to stimulation-off group

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Universität Innsbruck, Innsbruck, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACTIVA® PC neurostimulator (Model 37601)

Device

the stimulator in the stimulation group will be turned on after implantation of the device

Primary outcomes

  1. UHDRS-TMS difference

    Time frame: 12 weeks postoperatively compared to baseline

    Difference between the groups in the UHDRS total motor score (UHDRS-TMS) at 12 weeks postoperatively compared to baseline.

Secondary outcomes

  1. UHDRS-Chorea difference

    Time frame: 6 months postoperatively compared to baseline

    Difference in the Unified Huntington's Disease Rating Scale (UHDRS) chorea subscore (items 14-20)

  2. UHDRS-bradykinesia difference

    Time frame: 6 months postoperatively compared to baseline

    Difference in the UHDRS bradykinesia subscore (items 22-25 and 27-29)

  3. BFMDRS difference

    Time frame: 6 months postoperatively compared to baseline

    Difference in the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) motor score

  4. Reilmann Battery differences

    Time frame: 6 months postoperatively compared to baseline

    Difference in the Q-Motor "choreomotography" test (Reilmann Battery)

  5. MDRS difference

    Time frame: 6 months postoperatively compared to baseline

    Difference in the Mattis Dementia Rating Scale (MDRS)

  6. Verbal Fluency Test difference

    Time frame: 6 months postoperatively compared to baseline

    Difference in the Verbal Fluency Test (formal lexical, categorical, category change)

  7. SDMT difference

    Time frame: 6 months postoperatively compared to baseline

    Difference in the Symbol Digit Modalities Test (SDMT)

  8. STROOP Test differences

    Time frame: 6 months postoperatively compared to baseline

    Difference in STROOP word reading, colour naming and colour of the word naming

  9. HADS-SIS difference

    Time frame: 6 months postoperatively compared to baseline

    Difference in the Hospital Anxiety and Depression Scale combined with Snaith Irritability Scale (HADS-SIS)

  10. PBA-s difference

    Time frame: 6 months postoperatively compared to baseline

    Difference in the Problem Behaviours Assessment Short Form (PBA-s)

  11. SF 36 difference

    Time frame: 6 months postoperatively compared to baseline

    Difference in the Short Form (36) Health Survey (SF-36)

  12. CGI difference

    Time frame: 6 months postoperatively compared to baseline

    Difference in the Clinical Global Impression Scale (CGI)

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Collaborators

  • CHDI Foundation, Inc.
  • Egyptian Society of Neurological Surgeons
  • KKS Netzwerk
  • Medtronic
  • The George Institute

Registry information

Official study title

Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD): A Prospective, Randomised, Controlled, International, Multi-centre Study

Acronym: HD-DBS

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2015
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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