ID

23138

Description

Responsible Party: Prof. Dr. Volker Arnd Coenen, Prof. Dr. med., University Hospital Freiburg ClinicalTrials.gov Identifier: NCT02491554 History of Changes Other Study ID Numbers: P000847 DRKS00008913 ( Registry Identifier: German Clinical Trial Register ) Study First Received: June 30, 2015 Last Updated: December 6, 2016 Deep braIn Stimulation for Tremor TractographIC Versus Traditional (DISTINCT) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02491554

Link

https://clinicaltrials.gov/ct2/show/NCT02491554

Keywords

Versions (1)
  1. 25/06/17 25/06/17 -
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25 giugno 2017

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License

Creative Commons BY 4.0
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Eligibility Deep Brain Stimulation for Essential Tremor DRKS00008913 NCT02491554 DRKS00008913

English

Eligibility Deep Brain Stimulation for Essential Tremor NCT02491554 DRKS00008913

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

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.
Description

Essential Tremor

Data type

boolean

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

Tremor Scale

Data type

boolean

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

Essential Tremor Medication

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Description

Control Group

Data type

boolean

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

Major Depression with Suicidal Thoughts

Data type

boolean

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

Dementia

Data type

boolean

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

Acute psychosis

Data type

boolean

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

Patient incapability

Data type

boolean

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

Nursing Home care

Data type

boolean

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

Surgical contraindications

Data type

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
Description

Drug Interactions

Data type

boolean

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

Substance Use Disorder

Data type

boolean

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

Relationship

Data type

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;
Description

Contraceptive Methods

Data type

boolean

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

Gynaecological Status

Data type

boolean

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

Eligibility Deep Brain Stimulation for Essential Tremor NCT02491554 DRKS00008913

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