ID

23081

Beschrijving

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

Link

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

Trefwoorden

Versies (1)
  1. 22-06-17 22-06-17 -
Geüploaded op

22 juni 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Deep Brain Stimulation in Huntington's Disease DRKS00006785 NCT02535884 DRKS00006785

Engels

Eligibility Deep Brain Stimulation in Huntington's Disease NCT02535884 DRKS00006785

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

boolean

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

Huntington's Disease

Datatype

boolean

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

Huntington Disease Status

Datatype

boolean

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

Huntington Disease Treatment

Datatype

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)
Beschrijving

Dementia Score

Datatype

boolean

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

Stable Status

Datatype

boolean

Alias
UMLS CUI [1]
C0205360
Signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Beschrijving

Control Group

Datatype

boolean

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

Juvenile Huntington Disease or predominant bradykinesia

Datatype

boolean

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

Postural instability

Datatype

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)
Beschrijving

Comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
Acute suicidality
Beschrijving

Suicidality

Datatype

boolean

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

Acute psychosis

Datatype

boolean

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

Study Participation Status

Datatype

boolean

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

Cerebral atrophy

Datatype

boolean

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

Bleeding disorder

Datatype

boolean

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

Pacemaker or defibrillator

Datatype

boolean

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

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
Lactation
Beschrijving

Lactation

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
Terug naar het begin van de pagina

Similar models

Eligibility Deep Brain Stimulation in Huntington's Disease NCT02535884 DRKS00006785

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial