ID

43539

Description

Responsible Party: Dr. med. Michael Barbe, Dr. med., University of Cologne ClinicalTrials.gov Identifier: NCT02910024 History of Changes Other Study ID Numbers: Uni-Koeln-1778 U1111-1172-6026 ( Other Identifier: WHO ) CIV-15-09-013868 ( Other Identifier: EUDAMED ) DRKS00008963 ( Registry Identifier: DRKS ) Study First Received: September 8, 2016 Last Updated: September 19, 2016 Theta-Burst-Stimulation in Early Rehabilitation of Stroke (TheSiReS) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02910024

Link

https://clinicaltrials.gov/ct2/show/NCT02910024

Keywords

Versions (2)
  1. 7/9/17 7/9/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

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License

Creative Commons BY 4.0
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Eligibility Ischemic Stroke NCT02910024 DRKS00008963

English

Eligibility Ischemic Stroke NCT02910024 DRKS00008963

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Written consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Age: 40-90 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
First ischemic stroke
Description

Ischemic stroke

Data type

boolean

Alias
UMLS CUI [1]
C0948008
Hemiparesis with impaired hand motor function
Description

Hemiparesis

Data type

boolean

Alias
UMLS CUI [1]
C0018989
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
Subjects who are legally detained in an official institute (§20 MPG)
Description

Institutionalization

Data type

boolean

Alias
UMLS CUI [1]
C0021629
Participation in clinical trial within the last 12 weeks
Description

Study Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
Description

Electronic implants

Data type

boolean

Alias
UMLS CUI [1]
C0021102
Medication pump (e.g. insulin pump)
Description

Medication pump

Data type

boolean

Alias
UMLS CUI [1]
C0182537
Metal splinters in eye or head
Description

Metal splinters

Data type

boolean

Alias
UMLS CUI [1]
C2229035
Pregnancy / breastfeeding
Description

Gynaecological Status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Neurodegenerative disease
Description

Neurodegenerative disease

Data type

boolean

Alias
UMLS CUI [1]
C0524851
Neuroinflammatory disease
Description

Neuroinflammatory disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0205494
UMLS CUI [1,2]
C0021368
History of seizures / epilepsy
Description

Seizure, epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0014544
Alcohol and substance abuse
Description

Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
Insufficient compliance
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Malignant tumor within the last 5 years
Description

Malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
Psychiatric disease
Description

Mental disorder

Data type

boolean

Alias
UMLS CUI [1]
C0004936
Bihemispheric ischemic lesion
Description

Bihemispheric ischemic lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0228174
Known brain lesion (surgical, traumatic)
Description

Brain lesion

Data type

boolean

Alias
UMLS CUI [1]
C0221505
Evidence for enhanced cerebral pressure
Description

Enhanced cerebral pressure

Data type

boolean

Alias
UMLS CUI [1]
C0428713
Severe cardial dysfunction
Description

Cardiac dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C3277906
Life expectancy < 12 months
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
NIHSS Score > 20
Description

NIHSS

Data type

boolean

Alias
UMLS CUI [1]
C1697238
Blood glucose imbalances resistant to treatment (<50 mg/dl or >300 mg/dl)
Description

Blood glucose

Data type

boolean

Alias
UMLS CUI [1]
C0202042
Elevated blood pressure resistant to treatment (RR > 185/110mmHg)
Description

Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020538
Systemic Thrombolysis using r-tPA or thrombectomy within the last 24 hours before enrollment in study
Description

Thrombolysis

Data type

boolean

Alias
UMLS CUI [1]
C0040044
Medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization
Description

Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0013216
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Similar models

Eligibility Ischemic Stroke NCT02910024 DRKS00008963

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Informed Consent
Item
Written consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
Age: 40-90 years
boolean
C0001779 (UMLS CUI [1])
Ischemic stroke
Item
First ischemic stroke
boolean
C0948008 (UMLS CUI [1])
Hemiparesis
Item
Hemiparesis with impaired hand motor function
boolean
C0018989 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Institutionalization
Item
Subjects who are legally detained in an official institute (§20 MPG)
boolean
C0021629 (UMLS CUI [1])
Study Participation Status
Item
Participation in clinical trial within the last 12 weeks
boolean
C2348568 (UMLS CUI [1])
Electronic implants
Item
Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
boolean
C0021102 (UMLS CUI [1])
Medication pump
Item
Medication pump (e.g. insulin pump)
boolean
C0182537 (UMLS CUI [1])
Metal splinters
Item
Metal splinters in eye or head
boolean
C2229035 (UMLS CUI [1])
Gynaecological Status
Item
Pregnancy / breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Neurodegenerative disease
Item
Neurodegenerative disease
boolean
C0524851 (UMLS CUI [1])
Neuroinflammatory disease
Item
Neuroinflammatory disease
boolean
C0205494 (UMLS CUI [1,1])
C0021368 (UMLS CUI [1,2])
Seizure, epilepsy
Item
History of seizures / epilepsy
boolean
C0036572 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Substance Use Disorder
Item
Alcohol and substance abuse
boolean
C0038586 (UMLS CUI [1])
Compliance
Item
Insufficient compliance
boolean
C1321605 (UMLS CUI [1])
Malignancy
Item
Malignant tumor within the last 5 years
boolean
C0006826 (UMLS CUI [1])
Mental disorder
Item
Psychiatric disease
boolean
C0004936 (UMLS CUI [1])
Bihemispheric ischemic lesion
Item
Bihemispheric ischemic lesion
boolean
C0038454 (UMLS CUI [1,1])
C0228174 (UMLS CUI [1,2])
Brain lesion
Item
Known brain lesion (surgical, traumatic)
boolean
C0221505 (UMLS CUI [1])
Enhanced cerebral pressure
Item
Evidence for enhanced cerebral pressure
boolean
C0428713 (UMLS CUI [1])
Cardiac dysfunction
Item
Severe cardial dysfunction
boolean
C3277906 (UMLS CUI [1])
Life expectancy
Item
Life expectancy < 12 months
boolean
C0023671 (UMLS CUI [1])
NIHSS
Item
NIHSS Score > 20
boolean
C1697238 (UMLS CUI [1])
Blood glucose
Item
Blood glucose imbalances resistant to treatment (<50 mg/dl or >300 mg/dl)
boolean
C0202042 (UMLS CUI [1])
Hypertension
Item
Elevated blood pressure resistant to treatment (RR > 185/110mmHg)
boolean
C0020538 (UMLS CUI [1])
Thrombolysis
Item
Systemic Thrombolysis using r-tPA or thrombectomy within the last 24 hours before enrollment in study
boolean
C0040044 (UMLS CUI [1])
Pharmacotherapy
Item
Medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization
boolean
C0013216 (UMLS CUI [1])
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