ID

23443

Description

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

Link

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

Keywords

Versions (1)
  1. 7/4/17 7/4/17 -
Uploaded on

July 4, 2017

DOI

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Creative Commons BY 4.0
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Eligibility Apraxia DRKS00012292 NCT03185234 DRKS00012292

English

Eligibility Apraxia NCT03185234 DRKS00012292

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Left hemispheric ischemic stroke

Data type

boolean

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

Cologne Apraxia Screening

Data type

boolean

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

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Written Informed Consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
Pregnancy, breastfeeding and women without exclusion of pregnancy
Description

Gynaecological Status

Data type

boolean

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

Stroke Index

Data type

boolean

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

Central Nervous System Neoplasms

Data type

boolean

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

Life Expectancy

Data type

boolean

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

Substance Use Disorder

Data type

boolean

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

Mental Disorders

Data type

boolean

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

Epileptic seizure

Data type

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
Description

Continuous medication

Data type

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
Description

Study Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Heart pacemaker
Description

Pacemaker

Data type

boolean

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

Metal implants in the head

Data type

boolean

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

Craniectomy or trepanation

Data type

boolean

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

Skin Lesion

Data type

boolean

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

Cooperation

Data type

boolean

Alias
UMLS CUI [1]
C0392337
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Similar models

Eligibility Apraxia NCT03185234 DRKS00012292

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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