Eligibility Deep Brain Stimulation for Essential Tremor NCT02491554 DRKS00008913

Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Male or female patients aged ≥ 25 and ≤ 80 years
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
2. Patients with Essential Tremor according to the criteria of the consensus statement of the movement disorders society (Deuschl et al. 1998) are included with a medical treatment resistant and disabling postural and/or intentional tremor.
Descrizione

Essential Tremor

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0270736
3. FTMTRS to be completed within 42 days prior surgery
Descrizione

Tremor Scale

Tipo di dati

boolean

Alias
UMLS CUI [1]
C4034324
4. Stable tremor medication for at least 3 months prior inclusion
Descrizione

Essential Tremor Medication

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0270736
UMLS CUI [1,2]
C0013216
5. Written informed consent
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Descrizione

Control Group

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009932
1. Major Depression with suicidal thoughts or suicidal thoughts in history
Descrizione

Major Depression with Suicidal Thoughts

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0235196
2. Dementia (Mattis Dementia Rating Score ≤ 130)
Descrizione

Dementia

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0497327
3. Acute psychosis
Descrizione

Acute psychosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0281774
4. Patient incapability
Descrizione

Patient incapability

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3176592
5. Nursing care at home
Descrizione

Nursing Home care

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0260062
6. Surgical contraindications
Descrizione

Surgical contraindications

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0543467
7. Medications that are likely to cause interactions in the opinion of the investigator
Descrizione

Drug Interactions

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0687133
8. Known or persistent abuse of medication, drugs or alcohol
Descrizione

Substance Use Disorder

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038586
9. Persons who are in a relationship of dependence/employment with the sponsor or the investigator
Descrizione

Relationship

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0439849
10. Fertile women not using adequate contraceptive methods: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception;
Descrizione

Contraceptive Methods

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0700589
11. Current or planned pregnancy, nursing period
Descrizione

Gynaecological Status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Deep Brain Stimulation for Essential Tremor NCT02491554 DRKS00008913

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
1. Male or female patients aged ≥ 25 and ≤ 80 years
boolean
C0001779 (UMLS CUI [1])
Essential Tremor
Item
2. Patients with Essential Tremor according to the criteria of the consensus statement of the movement disorders society (Deuschl et al. 1998) are included with a medical treatment resistant and disabling postural and/or intentional tremor.
boolean
C0270736 (UMLS CUI [1])
Tremor Scale
Item
3. FTMTRS to be completed within 42 days prior surgery
boolean
C4034324 (UMLS CUI [1])
Essential Tremor Medication
Item
4. Stable tremor medication for at least 3 months prior inclusion
boolean
C0270736 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
Informed Consent
Item
5. Written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
0. Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Major Depression with Suicidal Thoughts
Item
1. Major Depression with suicidal thoughts or suicidal thoughts in history
boolean
C1269683 (UMLS CUI [1,1])
C0235196 (UMLS CUI [1,2])
Dementia
Item
2. Dementia (Mattis Dementia Rating Score ≤ 130)
boolean
C0497327 (UMLS CUI [1])
Acute psychosis
Item
3. Acute psychosis
boolean
C0281774 (UMLS CUI [1])
Patient incapability
Item
4. Patient incapability
boolean
C3176592 (UMLS CUI [1])
Nursing Home care
Item
5. Nursing care at home
boolean
C0260062 (UMLS CUI [1])
Surgical contraindications
Item
6. Surgical contraindications
boolean
C1301624 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Drug Interactions
Item
7. Medications that are likely to cause interactions in the opinion of the investigator
boolean
C0687133 (UMLS CUI [1])
Substance Use Disorder
Item
8. Known or persistent abuse of medication, drugs or alcohol
boolean
C0038586 (UMLS CUI [1])
Relationship
Item
9. Persons who are in a relationship of dependence/employment with the sponsor or the investigator
boolean
C0439849 (UMLS CUI [1])
Contraceptive Methods
Item
10. Fertile women not using adequate contraceptive methods: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception;
boolean
C0700589 (UMLS CUI [1])
Gynaecological Status
Item
11. Current or planned pregnancy, nursing period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])