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. 6/25/17 6/25/17 -
Uploaded on

June 25, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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
Back to the top of the page

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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial