ID

23443

Beskrivning

Responsible Party: Gereon R. Fink, Univ.-Prof. Dr. med., University of Cologne ClinicalTrials.gov Identifier: NCT03185234 History of Changes Other Study ID Numbers: Uni-Koeln-3033 U1111-1195-2536 ( Other Identifier: WHO ) DRKS00012292 ( Registry Identifier: DRKS ) Study First Received: May 31, 2017 Last Updated: June 23, 2017 Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation (RAdiCS) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT03185234

Länk

https://clinicaltrials.gov/ct2/show/NCT03185234

Nyckelord

Versioner (1)
  1. 2017-07-04 2017-07-04 -
Uppladdad den

4 juli 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Apraxia DRKS00012292 NCT03185234 DRKS00012292

Engelsk

Eligibility Apraxia NCT03185234 DRKS00012292

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Left hemispheric ischemic stroke in the subacute/ chronic phase (>10 days and <180 days post-stroke)
Beskrivning

Left hemispheric ischemic stroke

Datatyp

boolean

Alias
UMLS CUI [1]
C0586325
Clinical confirmation of apraxia by KAS (Cologne Apraxia Screening), Cut-off ≤ 76/ 80 points;
Beskrivning

Cologne Apraxia Screening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003635
UMLS CUI [1,2]
C0220908
Age 18 - 90 years;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Written 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
Pregnancy, breastfeeding and women without exclusion of pregnancy
Beskrivning

Gynaecological Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Patients with clinical manifestation of a stroke prior to the index-stroke
Beskrivning

Stroke Index

Datatyp

boolean

Alias
UMLS CUI [1]
C0456712
Malignant disease with affection of central nervous system
Beskrivning

Central Nervous System Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0085136
Life expectancy <12 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
Current addiction to alcohol or drugs or other addictive disease (exception: nicotine)
Beskrivning

Substance Use Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
Current clinically manifest psychiatric disorders, such as schizophrenia or severe depressive episode
Beskrivning

Mental Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
Epileptic seizure within the past two years
Beskrivning

Epileptic seizure

Datatyp

boolean

Alias
UMLS CUI [1]
C1411824
Continuous medication during the intervention phase with benzodiazepine, antipsychotics of high potential and anti-epileptic drugs taken for prophylaxis of epileptic seizures
Beskrivning

Continuous medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0549178
Enrollment in other studies with brain stimulation in the time period after the index stroke
Beskrivning

Study Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Heart pacemaker
Beskrivning

Pacemaker

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
electrodes for deep brain stimulation or other metal implants in the head (expected are dental fillings and inlays)
Beskrivning

Metal implants in the head

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0336580
UMLS CUI [1,2]
C0018670
Craniectomy or trepanation
Beskrivning

Craniectomy or trepanation

Datatyp

boolean

Alias
UMLS CUI [1]
C0195897
UMLS CUI [2]
C2363901
Vulnerable skin lesions at electrode positions
Beskrivning

Skin Lesion

Datatyp

boolean

Alias
UMLS CUI [1]
C0037284
Poor motivation/ cooperation
Beskrivning

Cooperation

Datatyp

boolean

Alias
UMLS CUI [1]
C0392337
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Similar models

Eligibility Apraxia NCT03185234 DRKS00012292

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Left hemispheric ischemic stroke
Item
Left hemispheric ischemic stroke in the subacute/ chronic phase (>10 days and <180 days post-stroke)
boolean
C0586325 (UMLS CUI [1])
Cologne Apraxia Screening
Item
Clinical confirmation of apraxia by KAS (Cologne Apraxia Screening), Cut-off ≤ 76/ 80 points;
boolean
C0003635 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Age
Item
Age 18 - 90 years;
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
Written 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])
Gynaecological Status
Item
Pregnancy, breastfeeding and women without exclusion of pregnancy
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Stroke Index
Item
Patients with clinical manifestation of a stroke prior to the index-stroke
boolean
C0456712 (UMLS CUI [1])
Central Nervous System Neoplasms
Item
Malignant disease with affection of central nervous system
boolean
C0085136 (UMLS CUI [1])
Life Expectancy
Item
Life expectancy <12 months
boolean
C0023671 (UMLS CUI [1])
Substance Use Disorder
Item
Current addiction to alcohol or drugs or other addictive disease (exception: nicotine)
boolean
C0038586 (UMLS CUI [1])
Mental Disorders
Item
Current clinically manifest psychiatric disorders, such as schizophrenia or severe depressive episode
boolean
C0004936 (UMLS CUI [1])
Epileptic seizure
Item
Epileptic seizure within the past two years
boolean
C1411824 (UMLS CUI [1])
Continuous medication
Item
Continuous medication during the intervention phase with benzodiazepine, antipsychotics of high potential and anti-epileptic drugs taken for prophylaxis of epileptic seizures
boolean
C0013216 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Study Participation Status
Item
Enrollment in other studies with brain stimulation in the time period after the index stroke
boolean
C2348568 (UMLS CUI [1])
Pacemaker
Item
Heart pacemaker
boolean
C0030163 (UMLS CUI [1])
Metal implants in the head
Item
electrodes for deep brain stimulation or other metal implants in the head (expected are dental fillings and inlays)
boolean
C0336580 (UMLS CUI [1,1])
C0018670 (UMLS CUI [1,2])
Craniectomy or trepanation
Item
Craniectomy or trepanation
boolean
C0195897 (UMLS CUI [1])
C2363901 (UMLS CUI [2])
Skin Lesion
Item
Vulnerable skin lesions at electrode positions
boolean
C0037284 (UMLS CUI [1])
Cooperation
Item
Poor motivation/ cooperation
boolean
C0392337 (UMLS CUI [1])
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