NCT00902889

Brief Summary

This is a single centre, controlled phase I study, which evaluates safety and efficacy of stimulation of lower caudal two contacts (GPI) vs. upper cranial two contacts (GPE) in Huntington´s disease (HD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

2.9 years

First QC Date

May 14, 2009

Last Update Submit

September 10, 2012

Conditions

Huntington's Disease

Keywords

Globus pallidusHuntington's DiseaseDeep Brain StimulationMovement Disorders

Outcome Measures

Primary Outcomes (1)

  • Efficacy of stimulation of GPI versus GPR (UHDRS Scale)

    3 months after stimulation treatment

Secondary Outcomes (5)

  • Effect of treatment on cognitive functions (neuropsychological tests)

    3 months after stimulation treatment

  • Effects of treatment on electrophysiological tests

    3 months after stimulation treatment

  • Effects of treatment on functional scale (functional ability, dependence scale, TFC)

    3 months after stimulation treatment

  • Progression of disease (motor UHDRS)

    12 months after stimulation treatment

  • Effect of treatment on striatal atrophy (CT Scans)

    3 months after stimulation treatment

Study Arms (2)

1

EXPERIMENTAL

6 weeks stimulation with GPI (lower caudal two contacts), 4 weeks wash-out, 6 weeks stimulation with GPE (upper cranial two contacts).

Procedure: Stimulation

2

EXPERIMENTAL

6 weeks stimulation with GPE (upper cranial two contacts), 4 weeks wash-out, 6 weeks stimulation with GPI (lower caudal two contacts)

Procedure: Stimulation

Interventions

StimulationPROCEDURE

6 weeks stimulation with GPI (lower caudal two contacts), 4 weeks wash-out, 6 weeks stimulation GPE (upper cranial two contacts)

Also known as: GPI, GPE
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinically symptomatic and genetically confirmed Huntington Disease (number of CAG repeats\>= 36)
  • age: \> 18
  • moderate stage of the disease (UHDRS motor\>= 30)
  • predominant movement disorder
  • signed informed consent

You may not qualify if:

  • advanced disease, precluding the ability to give informed consent
  • very early stage of disease causing minor disability
  • severe comorbidity that could compromise the life prognostic or preclude general anaesthesia or immunosuppression
  • Mattis Dementia Rating Scale \< 120
  • psychiatric or personality disturbances that might compromise the follow-up
  • participation at another trial (in particular transplantation)
  • severe cortical atrophy seen on CT and MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Functional Neurosurgery and Stereotaxy, Department of Neurosurgery University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (3)

  • Temel Y, Cao C, Vlamings R, Blokland A, Ozen H, Steinbusch HW, Michelsen KA, von Horsten S, Schmitz C, Visser-Vandewalle V. Motor and cognitive improvement by deep brain stimulation in a transgenic rat model of Huntington's disease. Neurosci Lett. 2006 Oct 2;406(1-2):138-41. doi: 10.1016/j.neulet.2006.07.036. Epub 2006 Aug 14.

    PMID: 16905252BACKGROUND

  • Ferrea S, Groiss SJ, Elben S, Hartmann CJ, Dunnett SB, Rosser A, Saft C, Schnitzler A, Vesper J, Wojtecki L; Surgical Approaches Working Group of the European Huntington's Disease Network (EHDN). Pallidal deep brain stimulation in juvenile Huntington's disease: local field potential oscillations and clinical data. J Neurol. 2018 Jul;265(7):1573-1579. doi: 10.1007/s00415-018-8880-1. Epub 2018 May 3.

    PMID: 29725840DERIVED

  • Beste C, Muckschel M, Elben S, J Hartmann C, McIntyre CC, Saft C, Vesper J, Schnitzler A, Wojtecki L. Behavioral and neurophysiological evidence for the enhancement of cognitive control under dorsal pallidal deep brain stimulation in Huntington's disease. Brain Struct Funct. 2015 Jul;220(4):2441-8. doi: 10.1007/s00429-014-0805-x. Epub 2014 May 31.

    PMID: 24878825DERIVED

MeSH Terms

Conditions

Huntington DiseaseMovement Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Jan Vesper, Prof. Dr.

    Functional Neurosurgery and Stereotaxy, Department of Neurosurgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2009

First Posted

May 15, 2009

Study Start

May 1, 2009

Primary Completion

April 1, 2012

Study Completion

July 1, 2012

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

DE(1)