ID

23081

Beskrivning

Responsible Party: Heinrich-Heine University, Duesseldorf ClinicalTrials.gov Identifier: NCT02535884 History of Changes Other Study ID Numbers: KKS-198 DRKS00006785 ( Registry Identifier: Deutsches Register Klinischer Studien ) Study First Received: August 27, 2015 Last Updated: January 23, 2017 Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD) (HD-DBS) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02535884

Länk

https://clinicaltrials.gov/ct2/show/NCT02535884

Nyckelord

Versioner (1)
  1. 2017-06-22 2017-06-22 -
Uppladdad den

22 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Deep Brain Stimulation in Huntington's Disease DRKS00006785 NCT02535884 DRKS00006785

Engelsk

Eligibility Deep Brain Stimulation in Huntington's Disease NCT02535884 DRKS00006785

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Clinically symptomatic and genetically confirmed HD (number of CAG repeats ≥ 36)
Beskrivning

Huntington's Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0020179
Moderate stage of the disease (UHDRS motor score ≥ 30)
Beskrivning

Huntington Disease Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020179
UMLS CUI [1,2]
C0699749
Chorea despite best medical treatment (UHDRS chorea subscore ≥ 10)
Beskrivning

Huntington Disease Treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020179
UMLS CUI [1,2]
C0087111
Mattis Dementia Rating Scale ≥ 120 (or > 80% of items testable independently from motor impairment)
Beskrivning

Dementia Score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0449820
Patient has stable medication prior six weeks before inclusion
Beskrivning

Stable Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0205360
Signed informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Beskrivning

Control Group

Datatyp

boolean

Alias
UMLS CUI [1]
C0009932
Juvenile HD (Westphal variant) or predominant bradykinesia
Beskrivning

Juvenile Huntington Disease or predominant bradykinesia

Datatyp

boolean

Alias
UMLS CUI [1]
C0751208
UMLS CUI [2]
C0233565
Postural instability with UHDRS retropulsion score > 2
Beskrivning

Postural instability

Datatyp

boolean

Alias
UMLS CUI [1]
C1843921
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)
Beskrivning

Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
Acute suicidality
Beskrivning

Suicidality

Datatyp

boolean

Alias
UMLS CUI [1]
C0438696
Acute psychosis (symptoms within previous 6 months)
Beskrivning

Acute psychosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0281774
Participation in any interventional clinical trial within 2 months before screening
Beskrivning

Study Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Cortical atrophy grade 3
Beskrivning

Cerebral atrophy

Datatyp

boolean

Alias
UMLS CUI [1]
C0235946
Patients with risk of coagulopathies and/or increased risk of haemorrhage
Beskrivning

Bleeding disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
Patients with an implanted pacemaker or defibrillator
Beskrivning

Pacemaker or defibrillator

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0180307
Pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
Lactation
Beskrivning

Lactation

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Deep Brain Stimulation in Huntington's Disease NCT02535884 DRKS00006785

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Ages Eligible for Study: 18 Years and older (Adult, Senior)
boolean
C0001779 (UMLS CUI [1])
Huntington's Disease
Item
Clinically symptomatic and genetically confirmed HD (number of CAG repeats ≥ 36)
boolean
C0020179 (UMLS CUI [1])
Huntington Disease Status
Item
Moderate stage of the disease (UHDRS motor score ≥ 30)
boolean
C0020179 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
Huntington Disease Treatment
Item
Chorea despite best medical treatment (UHDRS chorea subscore ≥ 10)
boolean
C0020179 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Dementia Score
Item
Mattis Dementia Rating Scale ≥ 120 (or > 80% of items testable independently from motor impairment)
boolean
C0497327 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Stable Status
Item
Patient has stable medication prior six weeks before inclusion
boolean
C0205360 (UMLS CUI [1])
Informed Consent
Item
Signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Juvenile Huntington Disease or predominant bradykinesia
Item
Juvenile HD (Westphal variant) or predominant bradykinesia
boolean
C0751208 (UMLS CUI [1])
C0233565 (UMLS CUI [2])
Postural instability
Item
Postural instability with UHDRS retropulsion score > 2
boolean
C1843921 (UMLS CUI [1])
Comorbidity
Item
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)
boolean
C0009488 (UMLS CUI [1])
Suicidality
Item
Acute suicidality
boolean
C0438696 (UMLS CUI [1])
Acute psychosis
Item
Acute psychosis (symptoms within previous 6 months)
boolean
C0281774 (UMLS CUI [1])
Study Participation Status
Item
Participation in any interventional clinical trial within 2 months before screening
boolean
C2348568 (UMLS CUI [1])
Cerebral atrophy
Item
Cortical atrophy grade 3
boolean
C0235946 (UMLS CUI [1])
Bleeding disorder
Item
Patients with risk of coagulopathies and/or increased risk of haemorrhage
boolean
C0005779 (UMLS CUI [1])
Pacemaker or defibrillator
Item
Patients with an implanted pacemaker or defibrillator
boolean
C0030163 (UMLS CUI [1])
C0180307 (UMLS CUI [2])
Pregnancy
Item
Pregnancy
boolean
C0032961 (UMLS CUI [1])
Lactation
Item
Lactation
boolean
C0006147 (UMLS CUI [1])
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