ID

23081

Description

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

Lien

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

Mots-clés

Versions (1)
  1. 22/06/2017 22/06/2017 -
Téléchargé le

22 juin 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

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

Anglais

Eligibility Deep Brain Stimulation in Huntington's Disease NCT02535884 DRKS00006785

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Type de données

boolean

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

Huntington's Disease

Type de données

boolean

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

Huntington Disease Status

Type de données

boolean

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

Huntington Disease Treatment

Type de données

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)
Description

Dementia Score

Type de données

boolean

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

Stable Status

Type de données

boolean

Alias
UMLS CUI [1]
C0205360
Signed informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Description

Control Group

Type de données

boolean

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

Juvenile Huntington Disease or predominant bradykinesia

Type de données

boolean

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

Postural instability

Type de données

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)
Description

Comorbidity

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
Acute suicidality
Description

Suicidality

Type de données

boolean

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

Acute psychosis

Type de données

boolean

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

Study Participation Status

Type de données

boolean

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

Cerebral atrophy

Type de données

boolean

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

Bleeding disorder

Type de données

boolean

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

Pacemaker or defibrillator

Type de données

boolean

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

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
Lactation
Description

Lactation

Type de données

boolean

Alias
UMLS CUI [1]
C0006147
Retour au début de la page

Similar models

Eligibility Deep Brain Stimulation in Huntington's Disease NCT02535884 DRKS00006785

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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