Huntington's DiseasePhase 1NCT00902889
Deep Brain Stimulation of the Globus Pallidus in Huntington's Disease
A Phase 1 study testing Stimulation in people with Huntington's Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington's Disease
- What is being tested?
- Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Jul 2012
- Phase
- Phase 1
- 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 Huntington Disease (number of CAG repeats>= 36)
- age: > 18
- moderate stage of the disease (UHDRS motor>= 30)
- predominant movement disorder
- compliance of the patient, stable cognition during a 6 months phase prior to inclusion (MDS>/= 120)
- signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Functional Neurosurgery and Stereotaxy, Department of Neurosurgery University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Single Centre (Pilot) Study for Deep Brain Stimulation (DBS) of the Globus Pallidus in Huntington's Disease (HD)
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).
Read the detailed description
A total of 6 HD patients will be selected out of an existing larger HD patient cohort upon careful evaluation of the inclusion and exclusion criteria at month 0. Patients will be recruited if no significant cognitive deterioration is observed between month 0 and month 3. The preoperative clinical status will be evaluated twice including the United Huntington Disease Rating Scale (UHDRS), neuropsychological, neurophysiologic and neuroradiological assessments. At 4 weeks postoperatively an extensive evaluation of effects and side effects of every single contact of the bilateral quadripolar electrodes takes place.
All patients will receive a stereotactic placement of bilateral stereotactic insertion of two quadripolar electrodes into the Globus pallidus, two contacts reaching the GPE, two the GPI within both hemispheres. Surgery will be done under general anesthesia, The implantation of the stimulator (Kintera®) will take place in the same procedure. Postoperatively patients will be monitored at three and six months and regularly up to 60 months with a battery of clinical, neuropsychological, psychiatric, neurophysiological and neuroimaging tests.
We expect that this trial will provide a rational basis to conclude about the efficacy, safety, reproducibility and long-term effects of pallidal Deep Brain Stimulation (DBS) on motor symptoms of HD.
- Conditions
- Huntington's Disease
- Being tested
- Stimulation
- Keywords
- Globus pallidus, Huntington's Disease, Deep Brain Stimulation, Movement Disorders
- Medical subject headings
- Huntington Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimulationProcedure or surgery
Also called GPI, GPE
6 weeks stimulation with GPI (lower caudal two contacts), 4 weeks wash-out, 6 weeks stimulation GPE (upper cranial two contacts)
StimulationProcedure or surgery
Also called GPE, GPI
6 weeks stimulation with GPE (upper cranial two contacts), 4 weeks wash-out, 6 weeks stimulation with GPI (lower caudal two contacts)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 6 weeks stimulation with GPI (lower caudal two contacts), 4 weeks wash-out, 6 weeks stimulation with GPE (upper cranial two contacts). Receives: 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) Receives: Procedure: Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of stimulation of GPI versus GPR (UHDRS Scale)
Measured: 3 months after stimulation treatment
Secondary outcomes (5)
Effect of treatment on cognitive functions (neuropsychological tests)
Measured: 3 months after stimulation treatment
Effects of treatment on electrophysiological tests
Measured: 3 months after stimulation treatment
Effects of treatment on functional scale (functional ability, dependence scale, TFC)
Measured: 3 months after stimulation treatment
Progression of disease (motor UHDRS)
Measured: 12 months after stimulation treatment
Effect of treatment on striatal atrophy (CT Scans)
Measured: 3 months after stimulation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Huntington's DiseaseStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Vesper, Prof. Dr., Principal investigator, Functional Neurosurgery and Stereotaxy, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902889
- Sponsor's protocol ID
- Huntington
- Status last verified
- Sep 2012
- First submitted
- 14 May 2009
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16905252Ferrea 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.
PubMed 29725840Beste 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.
PubMed 24878825
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Centre (Pilot) Study for Deep Brain Stimulation (DBS) of the Globus Pallidus in Huntington's Disease (HD)
- ClinicalTrials.gov ID
- NCT00902889
- Acronym / sponsor ID
- Huntington
- Conditions
- Huntington's Disease
- Keywords
- Globus pallidus, Huntington's Disease, Deep Brain Stimulation, Movement Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
A total of 6 HD patients will be selected out of an existing larger HD patient cohort upon careful evaluation of the inclusion and exclusion criteria at month 0. Patients will be recruited if no significant cognitive deterioration is observed between month 0 and month 3. The preoperative clinical status will be evaluated twice including the United Huntington Disease Rating Scale (UHDRS), neuropsychological, neurophysiologic and neuroradiological assessments. At 4 weeks postoperatively an extensive evaluation of effects and side effects of every single contact of the bilateral quadripolar electrodes takes place.
All patients will receive a stereotactic placement of bilateral stereotactic insertion of two quadripolar electrodes into the Globus pallidus, two contacts reaching the GPE, two the GPI within both hemispheres. Surgery will be done under general anesthesia, The implantation of the stimulator (Kintera®) will take place in the same procedure. Postoperatively patients will be monitored at three and six months and regularly up to 60 months with a battery of clinical, neuropsychological, psychiatric, neurophysiological and neuroimaging tests.
We expect that this trial will provide a rational basis to conclude about the efficacy, safety, reproducibility and long-term effects of pallidal Deep Brain Stimulation (DBS) on motor symptoms of HD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Stimulation6 weeks stimulation with GPI (lower caudal two contacts), 4 weeks wash-out, 6 weeks stimulation with GPE (upper cranial two contacts). |
| 2 | Experimental | Procedure: Stimulation6 weeks stimulation with GPE (upper cranial two contacts), 4 weeks wash-out, 6 weeks stimulation with GPI (lower caudal two contacts) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- compliance of the patient, stable cognition during a 6 months phase prior to inclusion (MDS>/= 120)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StimulationAlso: GPI, GPE6 weeks stimulation with GPI (lower caudal two contacts), 4 weeks wash-out, 6 weeks stimulation GPE (upper cranial two contacts) | Procedure or surgery | 1 |
| StimulationAlso: GPE, GPI6 weeks stimulation with GPE (upper cranial two contacts), 4 weeks wash-out, 6 weeks stimulation with GPI (lower caudal two contacts) | Procedure or surgery | 2 |
Primary outcome
Efficacy of stimulation of GPI versus GPR (UHDRS Scale)
Time frame: 3 months after stimulation treatment
5 secondary outcomes
Effect of treatment on cognitive functions (neuropsychological tests)
Time frame: 3 months after stimulation treatment
Effects of treatment on electrophysiological tests
Time frame: 3 months after stimulation treatment
Effects of treatment on functional scale (functional ability, dependence scale, TFC)
Time frame: 3 months after stimulation treatment
Progression of disease (motor UHDRS)
Time frame: 12 months after stimulation treatment
Effect of treatment on striatal atrophy (CT Scans)
Time frame: 3 months after stimulation treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
- Background: PubMed 16905252Temel 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.
- Derived from this study: PubMed 29725840Ferrea 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.
- Derived from this study: PubMed 24878825Beste 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Vesper, Prof. Dr. principal investigator
Functional Neurosurgery and Stereotaxy, Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stimulation in people with Huntington's Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 6 inclusion and 7 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 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy of stimulation of GPI versus GPR (UHDRS Scale) (time frame: 3 months after stimulation treatment). 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 NCT00902889, which also lists 3 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 11 Sep 2012.