ID

18773

Beschreibung

Transcranial Direct Current Stimulation to Treat Symptoms of Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00082342

Link

https://clinicaltrials.gov/show/NCT00082342

Stichworte

Versionen (1)
  1. 20.11.16 20.11.16 -
Hochgeladen am

20. November 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00082342

Englisch

Eligibility Parkinson Disease NCT00082342

1 Formulare  
Criteria
Beschreibung

Criteria

patients with pd corresponding to inclusion criteria will be recruited from the human motor control section clinic (hmcs).
Beschreibung

Parkinson Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0030567
subjects will be men and women aged 40-80 years with dopa-responsive, akinetic-rigid pd.
Beschreibung

Age | Parkinson Disease Dopa Responsive | Parkinson Disease Akinetic Rigid

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030567
UMLS CUI [2,2]
C0013023
UMLS CUI [2,3]
C0205342
UMLS CUI [3,1]
C0030567
UMLS CUI [3,2]
C0233568
UMLS CUI [3,3]
C0026837
patients who have never participated in hmcs protocols for pd will be interviewed and examined by either the principal investigator or a physician from the brain stimulation unit or hmcs in order to establish the diagnosis of pd and rule out any neurological condition. only patients with a hoehm and yahr grade of 2 to 4 while "off" will be accepted.
Beschreibung

Study Subject Participation Status | patient interview | Physical Examination | Parkinson Disease | Condition Neurologic | Hoehn and Yahr grades

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0683518
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0030567
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0205494
UMLS CUI [6]
C0451215
patients must be on a regimen including levodopa. the total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 375 milligrams per day. other anti-parkinsonian medications are also acceptable.
Beschreibung

Levodopa | Dopamine Agonists | Medication dose per day Dopamine Equivalent | Antiparkinson Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0178601
UMLS CUI [3,1]
C3174092
UMLS CUI [3,2]
C0439505
UMLS CUI [3,3]
C0013030
UMLS CUI [3,4]
C0205163
UMLS CUI [4]
C0003405
patients should have problems with walking, including freezing, so that their gait time for a 10-meter distance will be six seconds or more.
Beschreibung

Difficulty walking | Freezing | Gait Time Distance

Datentyp

boolean

Alias
UMLS CUI [1]
C0311394
UMLS CUI [2]
C0860515
UMLS CUI [3,1]
C0016928
UMLS CUI [3,2]
C0040223
UMLS CUI [3,3]
C0012751
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclusion criteria are any significant medical or psychiatric illnesses (except those symptoms often associated with pd or levodopa therapy, such as sundowning and benign hallucination), pallidotomy, implanted electrodes and generator for deep brain stimulation, pregnancy.
Beschreibung

Illness Significant | Mental disorders Significant | Parkinson Disease | Levodopa | Sundowning | Hallucinations Benign | Pallidotomy | Electrodes, Implanted | Deep brain electrical stimulation system pulse generator | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0750502
UMLS CUI [3]
C0030567
UMLS CUI [4]
C0023570
UMLS CUI [5]
C1142436
UMLS CUI [6,1]
C0018524
UMLS CUI [6,2]
C0205183
UMLS CUI [7]
C0195893
UMLS CUI [8]
C0013814
UMLS CUI [9]
C4075668
UMLS CUI [10]
C0032961
persons with surgically or traumatically implanted foreign bodies such as a pacemaker, implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during tep will also be excluded. most of these exclusions also come under the category of significant medical illness.
Beschreibung

Implanted Medical Device | Artificial cardiac pacemaker | pump Medical Implant | Hearing Aids Implant | skull-plate; present | Metallic foreign body skull | Metal foreign body in eye region | Dental appliances | tooth filling | Physical hazard | Total Hip Replacement | Illness Significant

Datentyp

boolean

Alias
UMLS CUI [1]
C2828363
UMLS CUI [2]
C0030163
UMLS CUI [3,1]
C0182537
UMLS CUI [3,2]
C0205476
UMLS CUI [3,3]
C0021102
UMLS CUI [4,1]
C0018768
UMLS CUI [4,2]
C0021102
UMLS CUI [5]
C1409480
UMLS CUI [6,1]
C1720389
UMLS CUI [6,2]
C2951888
UMLS CUI [7]
C0562528
UMLS CUI [8]
C0441319
UMLS CUI [9]
C0178866
UMLS CUI [10]
C0337044
UMLS CUI [11]
C0040508
UMLS CUI [12,1]
C0221423
UMLS CUI [12,2]
C0750502
patients for whom participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness will also be excluded.
Beschreibung

Reasons At risk Study Subject Participation Status | Tendency to fall | Fatigue Excessive | Frailty General | apprehensiveness Excessive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3841427
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C2348568
UMLS CUI [2]
C2830327
UMLS CUI [3,1]
C0015672
UMLS CUI [3,2]
C0442802
UMLS CUI [4,1]
C0424594
UMLS CUI [4,2]
C0205246
UMLS CUI [5,1]
C1408583
UMLS CUI [5,2]
C0442802
patients unable to walk a 10-meter distance will be excluded.
Beschreibung

Able to walk Distance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0012751
mentally impaired patients having no capacity to provide their own consent will be excluded from the study.
Beschreibung

Mentally Disabled Persons | Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1]
C0079822
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
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Ähnliche Modelle

Eligibility Parkinson Disease NCT00082342

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Parkinson Disease
Item
patients with pd corresponding to inclusion criteria will be recruited from the human motor control section clinic (hmcs).
boolean
C0030567 (UMLS CUI [1])
Age | Parkinson Disease Dopa Responsive | Parkinson Disease Akinetic Rigid
Item
subjects will be men and women aged 40-80 years with dopa-responsive, akinetic-rigid pd.
boolean
C0001779 (UMLS CUI [1])
C0030567 (UMLS CUI [2,1])
C0013023 (UMLS CUI [2,2])
C0205342 (UMLS CUI [2,3])
C0030567 (UMLS CUI [3,1])
C0233568 (UMLS CUI [3,2])
C0026837 (UMLS CUI [3,3])
Study Subject Participation Status | patient interview | Physical Examination | Parkinson Disease | Condition Neurologic | Hoehn and Yahr grades
Item
patients who have never participated in hmcs protocols for pd will be interviewed and examined by either the principal investigator or a physician from the brain stimulation unit or hmcs in order to establish the diagnosis of pd and rule out any neurological condition. only patients with a hoehm and yahr grade of 2 to 4 while "off" will be accepted.
boolean
C2348568 (UMLS CUI [1])
C0683518 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0030567 (UMLS CUI [4])
C0348080 (UMLS CUI [5,1])
C0205494 (UMLS CUI [5,2])
C0451215 (UMLS CUI [6])
Levodopa | Dopamine Agonists | Medication dose per day Dopamine Equivalent | Antiparkinson Agents
Item
patients must be on a regimen including levodopa. the total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 375 milligrams per day. other anti-parkinsonian medications are also acceptable.
boolean
C0023570 (UMLS CUI [1])
C0178601 (UMLS CUI [2])
C3174092 (UMLS CUI [3,1])
C0439505 (UMLS CUI [3,2])
C0013030 (UMLS CUI [3,3])
C0205163 (UMLS CUI [3,4])
C0003405 (UMLS CUI [4])
Difficulty walking | Freezing | Gait Time Distance
Item
patients should have problems with walking, including freezing, so that their gait time for a 10-meter distance will be six seconds or more.
boolean
C0311394 (UMLS CUI [1])
C0860515 (UMLS CUI [2])
C0016928 (UMLS CUI [3,1])
C0040223 (UMLS CUI [3,2])
C0012751 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Illness Significant | Mental disorders Significant | Parkinson Disease | Levodopa | Sundowning | Hallucinations Benign | Pallidotomy | Electrodes, Implanted | Deep brain electrical stimulation system pulse generator | Pregnancy
Item
exclusion criteria are any significant medical or psychiatric illnesses (except those symptoms often associated with pd or levodopa therapy, such as sundowning and benign hallucination), pallidotomy, implanted electrodes and generator for deep brain stimulation, pregnancy.
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0030567 (UMLS CUI [3])
C0023570 (UMLS CUI [4])
C1142436 (UMLS CUI [5])
C0018524 (UMLS CUI [6,1])
C0205183 (UMLS CUI [6,2])
C0195893 (UMLS CUI [7])
C0013814 (UMLS CUI [8])
C4075668 (UMLS CUI [9])
C0032961 (UMLS CUI [10])
Implanted Medical Device | Artificial cardiac pacemaker | pump Medical Implant | Hearing Aids Implant | skull-plate; present | Metallic foreign body skull | Metal foreign body in eye region | Dental appliances | tooth filling | Physical hazard | Total Hip Replacement | Illness Significant
Item
persons with surgically or traumatically implanted foreign bodies such as a pacemaker, implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during tep will also be excluded. most of these exclusions also come under the category of significant medical illness.
boolean
C2828363 (UMLS CUI [1])
C0030163 (UMLS CUI [2])
C0182537 (UMLS CUI [3,1])
C0205476 (UMLS CUI [3,2])
C0021102 (UMLS CUI [3,3])
C0018768 (UMLS CUI [4,1])
C0021102 (UMLS CUI [4,2])
C1409480 (UMLS CUI [5])
C1720389 (UMLS CUI [6,1])
C2951888 (UMLS CUI [6,2])
C0562528 (UMLS CUI [7])
C0441319 (UMLS CUI [8])
C0178866 (UMLS CUI [9])
C0337044 (UMLS CUI [10])
C0040508 (UMLS CUI [11])
C0221423 (UMLS CUI [12,1])
C0750502 (UMLS CUI [12,2])
Reasons At risk Study Subject Participation Status | Tendency to fall | Fatigue Excessive | Frailty General | apprehensiveness Excessive
Item
patients for whom participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness will also be excluded.
boolean
C3841427 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C2830327 (UMLS CUI [2])
C0015672 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0424594 (UMLS CUI [4,1])
C0205246 (UMLS CUI [4,2])
C1408583 (UMLS CUI [5,1])
C0442802 (UMLS CUI [5,2])
Able to walk Distance
Item
patients unable to walk a 10-meter distance will be excluded.
boolean
C2712089 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
Mentally Disabled Persons | Informed Consent Unable
Item
mentally impaired patients having no capacity to provide their own consent will be excluded from the study.
boolean
C0079822 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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