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Huntington DiseaseHD-DBSNCT02535884

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

A study testing ACTIVA® PC neurostimulator (Model 37601) in people with Huntington Disease, run by Heinrich-Heine University, Duesseldorf at 12 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Huntington Disease
What is being tested?
ACTIVA® PC neurostimulator (Model 37601)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
12 sitesin 4 countries
Study dates
Jul 2014to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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 locations and contacts

12 sites in 4 countries.

12 sites in 4 countries

Germany7 sites

  • Charité Campus Virchow Klinikum

    Berlin, 13353

  • University hospital Heinrich Heine University Düsseldorf

    Düsseldorf, 40225

  • University Hospital Freiburg

    Freiburg im Breisgau, 79106

  • University Hospital Schleswig-Holstein

    Kiel, 24105

  • Universität zu Lübeck

    Lübeck, 23562

  • University hospital Munich LMU

    Munich, 80336

  • kbo-Isar-Amper-Clinic Taufkirchen

    Taufkirchen, 84416

Other trials in Germany

France2 sites

  • CHU Amiens Hôpital nord, Department of neurosurgery and Department of neurology

    Amiens, 80054

  • Hôpital Roger Salengro, Service de Neurologie et Pathologie du mouvement

    Lille, 59037

Other trials in France

Switzerland2 sites

  • Center for Neurology

    Bern, Gümlingen, 3073

  • Inselspital, Department of Neurology

    Bern, 3010

Other trials in Switzerland

Austria1 site

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

Other trials in Austria

About this study

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

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

Read the detailed description

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.

Being tested
ACTIVA® PC neurostimulator (Model 37601)
Keywords
Huntington Disease, DBS, Chorea
Medical subject headings
Huntington Disease, Chorea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACTIVA® PC neurostimulator (Model 37601)Device

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

Study groups in NCT02535884
Study groupRoleWhat they receive
Stimulation groupExperimentalPatients in the stimulation group will be stimulated immediately after implantation of the Stimulator (ACTIVA® PC neurostimulator (Model 37601))
Receives: Device: ACTIVA® PC neurostimulator (Model 37601)
Non-stimulation groupSham comparatorPatients in the non-stimulation group will not be stimulated for the first three months after implantation of the Stimulator (ACTIVA® PC neurostimulator (Model 37601))
Receives: Device: ACTIVA® PC neurostimulator (Model 37601)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. UHDRS-TMS difference

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

    Measured: 12 weeks postoperatively compared to baseline

Secondary outcomes (12)

  1. UHDRS-Chorea difference

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

    Measured: 6 months postoperatively compared to baseline

  2. UHDRS-bradykinesia difference

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

    Measured: 6 months postoperatively compared to baseline

  3. BFMDRS difference

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

    Measured: 6 months postoperatively compared to baseline

  4. Reilmann Battery differences

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

    Measured: 6 months postoperatively compared to baseline

  5. MDRS difference

    Difference in the Mattis Dementia Rating Scale (MDRS)

    Measured: 6 months postoperatively compared to baseline

  6. Verbal Fluency Test difference

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

    Measured: 6 months postoperatively compared to baseline

  7. SDMT difference

    Difference in the Symbol Digit Modalities Test (SDMT)

    Measured: 6 months postoperatively compared to baseline

  8. STROOP Test differences

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

    Measured: 6 months postoperatively compared to baseline

  9. HADS-SIS difference

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

    Measured: 6 months postoperatively compared to baseline

  10. PBA-s difference

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

    Measured: 6 months postoperatively compared to baseline

  11. SF 36 difference

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

    Measured: 6 months postoperatively compared to baseline

  12. CGI difference

    Difference in the Clinical Global Impression Scale (CGI)

    Measured: 6 months postoperatively compared to baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2015 (estimated)
  2. Study startJul 2014
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
During the first 3 month the one group will be stimulated (pallidal DBS), thereafter 12 weeks open follow up, where patients in both groups are stimulated.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02535884
Sponsor's protocol ID
KKS-198
Other IDs
DRKS00006785
Acronym
HD-DBS
Status last verified
Jan 2022
First submitted
27 Aug 2015
Last updated
21 Jan 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: After the study the data will be provided to the CHDI. The Foundation may use, and make available for use by the Foundation Collaborators, the Study Data for the following purposes: (A) to design and guide future research studies and clinical trials and (B) to support and enable the following scientific discussion and research: (1) to better understand HD or other diseases being studied, (2) that furthers the development of treatments for HD or other diseases or (3) that furthers biomedical research.

Publications

  • Moro E, Lang AE, Strafella AP, Poon YY, Arango PM, Dagher A, Hutchison WD, Lozano AM. Bilateral globus pallidus stimulation for Huntington's disease. Ann Neurol. 2004 Aug;56(2):290-4. doi: 10.1002/ana.20183.

    PubMed 15293283

  • Groiss SJ WL, Suedmeyer, M, Ploner M, Reck C, Voges J, SturmV, Timmermann L, Schnitzler A. Effect of bilateral pallidal deep brain stimulation in Huntington's disease: A case report. Mov Disord, Volume 21, Issue S15. Tenth International Congress of Parkinson's Disease and Movement Disorders. Kyoto 2006.

  • Fasano A, Cadeddu F, Guidubaldi A, Piano C, Soleti F, Zinzi P, Bentivoglio AR. The long-term effect of tetrabenazine in the management of Huntington disease. Clin Neuropharmacol. 2008 Nov-Dec;31(6):313-8. doi: 10.1097/WNF.0b013e318166da60.

    PubMed 19050408

  • Wojtecki L, Groiss SJ, Ferrea S, Elben S, Hartmann CJ, Dunnett SB, Rosser A, Saft C, Sudmeyer M, Ohmann C, Schnitzler A, Vesper J; Surgical Approaches Working Group of the European Huntington's Disease Network (EHDN). A Prospective Pilot Trial for Pallidal Deep Brain Stimulation in Huntington's Disease. Front Neurol. 2015 Aug 18;6:177. doi: 10.3389/fneur.2015.00177. eCollection 2015.

    PubMed 26347707

  • Wojtecki L, Groiss SJ, Hartmann CJ, Elben S, Omlor S, Schnitzler A, Vesper J. Deep Brain Stimulation in Huntington's Disease-Preliminary Evidence on Pathophysiology, Efficacy and Safety. Brain Sci. 2016 Aug 30;6(3):38. doi: 10.3390/brainsci6030038.

    PubMed 27589813

  • Kinfe T, Del Vecchio A, Nussel M, Zhao Y, Stadlbauer A, Buchfelder M. Deep brain stimulation and stereotactic-assisted brain graft injection targeting fronto-striatal circuits for Huntington's disease: an update. Expert Rev Neurother. 2022 Sep;22(9):781-788. doi: 10.1080/14737175.2022.2091988. Epub 2022 Jun 29.

    PubMed 35766355

  • Rodrigues FB, Ferreira JJ, Wild EJ. Huntington's Disease Clinical Trials Corner: June 2019. J Huntingtons Dis. 2019;8(3):363-371. doi: 10.3233/JHD-199003.

    PubMed 31381524

  • Hartmann CJ, Groiss SJ, Vesper J, Schnitzler A, Wojtecki L. Brain stimulation in Huntington's disease. Neurodegener Dis Manag. 2016 Jun;6(3):223-36. doi: 10.2217/nmt-2016-0007. Epub 2016 May 27.

    PubMed 27230813

Questions about this trial

What is this clinical trial studying?

A study testing ACTIVA® PC neurostimulator (Model 37601) in people with Huntington Disease, run by Heinrich-Heine University, Duesseldorf at 12 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany, France, Switzerland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

UHDRS-TMS difference (time frame: 12 weeks postoperatively compared to baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02535884, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.

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