ID

32174

Description

Tolerability, Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00685321

Lien

https://clinicaltrials.gov/show/NCT00685321

Mots-clés

Versions (1)
  1. 22/10/2018 22/10/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

22 octobre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00685321

Anglais

Eligibility Schizophrenia NCT00685321

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients between the ages of 18-65 (male and female), diagnosed in the past as suffering from schizophrenia. the diagnosis will be reaffirmed according to icd criteria.
Description

Age | Schizophrenia

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0036341
2. right hand dominant.
Description

Handedness

Type de données

boolean

Alias
UMLS CUI [1]
C0023114
3. scores in panss negative questionnaire above 21.
Description

PANSS Questionnaires Negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C4086747
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C1513916
4. gave informed consent for participation in the study.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
5. negative answers on safety screening questionnaire for transcranial magnetic stimulation
Description

Questionnaires Transcranial magnetic stimulation | Questionnaires Safety Answer Negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0436548
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0036043
UMLS CUI [2,3]
C1706817
UMLS CUI [2,4]
C1513916
6. stable on the same antipsychotic medication for at least two months prior to entering the study.
Description

Antipsychotic Agent Same Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0445247
UMLS CUI [1,3]
C0205360
7. negative answers to all questions in the tms safety questionnaire (attached ).
Description

Questionnaires Transcranial magnetic stimulation | Questionnaires Safety Answer Negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0436548
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0036043
UMLS CUI [2,3]
C1706817
UMLS CUI [2,4]
C1513916
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. diagnosed as suffering from another axis 1 disorder .
Description

Axis I diagnosis Other

Type de données

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205394
2. scores in panss positive questionnaire above 24.
Description

PANSS Questionnaire Positive

Type de données

boolean

Alias
UMLS CUI [1,1]
C4086747
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C1514241
3. history of epilepsy, seizure, or hot spasm.
Description

Epilepsy | Seizures | Spasm

Type de données

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0037763
4. history of epilepsy within first-degree relatives.
Description

Epilepsy First Degree Relative

Type de données

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C1517194
5. history of head injuries.
Description

Craniocerebral Trauma

Type de données

boolean

Alias
UMLS CUI [1]
C0018674
6. history of metal in the head (outside the mouth space).
Description

Metal in head | Exception Oral cavity

Type de données

boolean

Alias
UMLS CUI [1]
C0561024
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0226896
7. history of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
Description

Operative Surgical Procedures | Metallic implant | Metal foreign body in eye region | Artificial cardiac pacemaker | Pump

Type de données

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C3693688
UMLS CUI [3]
C0562528
UMLS CUI [4]
C0030163
UMLS CUI [5]
C0182537
8. history of migraines.
Description

Migraine

Type de données

boolean

Alias
UMLS CUI [1]
C0149931
9. history of hearing loss (not due to aging) or cochlear implants.
Description

Hearing loss | Etiology Absent Aging | Cochlear Implants

Type de données

boolean

Alias
UMLS CUI [1]
C0011053
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0001811
UMLS CUI [3]
C0009199
10. history of drug or alcohol abuse during the last year.
Description

Substance Use Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
11. women - pregnancy or not using a reliable method of birth control.
Description

Pregnancy | Gender Contraceptive methods Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
12. inability to achieve satisfying level of communication with the subject.
Description

Communication Level Unsatisfactory

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009452
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C0439856
13. suicide attempt in the year prior to treatment or suicide risk according to a suicide questionnaire
Description

Suicide attempt | At risk for suicide Suicide Questionnaire

Type de données

boolean

Alias
UMLS CUI [1]
C0038663
UMLS CUI [2,1]
C0563664
UMLS CUI [2,2]
C0038661
UMLS CUI [2,3]
C0034394
14. custodians.
Description

Legal custodians

Type de données

boolean

Alias
UMLS CUI [1]
C0023226
15. participation in another medical study during the experiment.
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Schizophrenia NCT00685321

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age | Schizophrenia
Item
1. patients between the ages of 18-65 (male and female), diagnosed in the past as suffering from schizophrenia. the diagnosis will be reaffirmed according to icd criteria.
boolean
C0001779 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
Handedness
Item
2. right hand dominant.
boolean
C0023114 (UMLS CUI [1])
PANSS Questionnaires Negative
Item
3. scores in panss negative questionnaire above 21.
boolean
C4086747 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Informed Consent
Item
4. gave informed consent for participation in the study.
boolean
C0021430 (UMLS CUI [1])
Questionnaires Transcranial magnetic stimulation | Questionnaires Safety Answer Negative
Item
5. negative answers on safety screening questionnaire for transcranial magnetic stimulation
boolean
C0034394 (UMLS CUI [1,1])
C0436548 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0036043 (UMLS CUI [2,2])
C1706817 (UMLS CUI [2,3])
C1513916 (UMLS CUI [2,4])
Antipsychotic Agent Same Stable
Item
6. stable on the same antipsychotic medication for at least two months prior to entering the study.
boolean
C0040615 (UMLS CUI [1,1])
C0445247 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Questionnaires Transcranial magnetic stimulation | Questionnaires Safety Answer Negative
Item
7. negative answers to all questions in the tms safety questionnaire (attached ).
boolean
C0034394 (UMLS CUI [1,1])
C0436548 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0036043 (UMLS CUI [2,2])
C1706817 (UMLS CUI [2,3])
C1513916 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis Other
Item
1. diagnosed as suffering from another axis 1 disorder .
boolean
C0270287 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
PANSS Questionnaire Positive
Item
2. scores in panss positive questionnaire above 24.
boolean
C4086747 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Epilepsy | Seizures | Spasm
Item
3. history of epilepsy, seizure, or hot spasm.
boolean
C0014544 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
C0037763 (UMLS CUI [3])
Epilepsy First Degree Relative
Item
4. history of epilepsy within first-degree relatives.
boolean
C0014544 (UMLS CUI [1,1])
C1517194 (UMLS CUI [1,2])
Craniocerebral Trauma
Item
5. history of head injuries.
boolean
C0018674 (UMLS CUI [1])
Metal in head | Exception Oral cavity
Item
6. history of metal in the head (outside the mouth space).
boolean
C0561024 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0226896 (UMLS CUI [2,2])
Operative Surgical Procedures | Metallic implant | Metal foreign body in eye region | Artificial cardiac pacemaker | Pump
Item
7. history of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
boolean
C0543467 (UMLS CUI [1])
C3693688 (UMLS CUI [2])
C0562528 (UMLS CUI [3])
C0030163 (UMLS CUI [4])
C0182537 (UMLS CUI [5])
Migraine
Item
8. history of migraines.
boolean
C0149931 (UMLS CUI [1])
Hearing loss | Etiology Absent Aging | Cochlear Implants
Item
9. history of hearing loss (not due to aging) or cochlear implants.
boolean
C0011053 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0001811 (UMLS CUI [2,3])
C0009199 (UMLS CUI [3])
Substance Use Disorders
Item
10. history of drug or alcohol abuse during the last year.
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Gender Contraceptive methods Absent
Item
11. women - pregnancy or not using a reliable method of birth control.
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Communication Level Unsatisfactory
Item
12. inability to achieve satisfying level of communication with the subject.
boolean
C0009452 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C0439856 (UMLS CUI [1,3])
Suicide attempt | At risk for suicide Suicide Questionnaire
Item
13. suicide attempt in the year prior to treatment or suicide risk according to a suicide questionnaire
boolean
C0038663 (UMLS CUI [1])
C0563664 (UMLS CUI [2,1])
C0038661 (UMLS CUI [2,2])
C0034394 (UMLS CUI [2,3])
Legal custodians
Item
14. custodians.
boolean
C0023226 (UMLS CUI [1])
Study Subject Participation Status
Item
15. participation in another medical study during the experiment.
boolean
C2348568 (UMLS CUI [1])
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