- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02161172
Cognitive and Psychosocial Outcome After Mild Traumatic Brain Injury
8. august 2020 opdateret af: Hao Chen, Shanghai 6th People's Hospital
Cognitive, Functional, and Psychosocial Outcome After Mild Traumatic Brain Injury: a Cross-sectional Study at a Tertiary Care Trauma Center.
Patients with traumatic brain injury are likely to present with cognitive, psychological, emotional and behavioral problems during different periods, all of which affect patients' life quality seriously.
The aim of this study was to assess cognitive and psychosocial outcome in patients with mild traumatic brain injury, and to determine the risk factors associated with cognitive and psychological outcome.
Mini-mental state examination (MMSE), activities of daily living scale (ADL), the Hospital Anxiety Depression Scale (HADS) and mental health symptom checklist (SCL-90) were used to assess the cognitive performance and psychological outcomes in 360 patients with mild traumatic brain injury.
Chi-square, Fisher's exact tests and Logistic regression analysis were used to analyze the risk factors.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
360
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Shanghai, Kina, 200233
- Shanghai sixth people's hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
360 patients with mild traumatic brain injury were enrolled in this study.
Their age ranged from 18 to 60 years, with mean age of 54.3 years.
Types of trauma included scalp hematoma, scalp laceration, cerebral contusion, subarachnoid hemorrhage, cerebral concussion, epidural hematoma, subdural hematoma and skull fracture.
Mechanisms of injury contained traffic accident, fall, industrial accident, etc. Occupation of patients included cadres, workers, farmers, individual, unemployed.
Education: college or above, middle school, primary school.
Beskrivelse
Inclusion Criteria:
- 18 ~ 60 years old
- Education: primary school and above, who could understand the content of psychological test
- History of brain trauma
- No taking of antipsychotic or any other drugs affecting central nervous system before the test
- Glasgow coma score (GCS) was 13-15
Exclusion Criteria:
- History of craniocerebral injury, brain disease, mental disease
- With mental retardation
- with other serious body diseases
- History of drug and alcohol dependence
- With color-blind or color weakness
- Who had severe visual and auditory disorders after brain injury
- Who failed or failed in completing the test effectively
- With cognitive impairment caused by the damage of the unilateral frontal or bilateral lobes, or with language dysfunction caused by temporal lobe damage
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Mild traumatic brain injury
Traumatic brain injury patients with Glasgow coma score (GCS) of 13-15.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mini-Mental State Examination
Tidsramme: 6 months
|
MMSE includes seven factors, namely: the time orientation factor (5 points), place orientation (5 points), immediate memory (3 points), short-term memory (3 points), calculation capabilities (5 points), verbal expression, naming and repetition (4 points), speech reading and understanding (4 points), graphic depiction (1 points).
The scales for the description of cognitive function impairment were grouped into three levels of education: illiteracy (17 points), primary school (20 points) and middle school (24 points).
The one with score below average was considered with cognitive function impairment.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Activity of daily living scale
Tidsramme: 6 months
|
The scale is divided into two parts: physical self-care ability, instrumental activities of daily living. 1 point for each option means normal; If 2~4 points for one option, he or she probably had ability decline; If two or more parts ≥3 points or total score≥ 22 points (14 questions), he or she exhibited living ability decline clearly.
|
6 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hospital anxiety and depression Scale
Tidsramme: 6 months
|
The scale includes 14 items and each has 0-3 points.
The score of the former seven items > 7, indicating depression symptom; the later seven items > 7, indicating anxiety symptom.
|
6 months
|
|
Symptom Check-List 90
Tidsramme: 6 months
|
This scale has been widely used to patients with neurosis, adjustment disorder and other slight mental psychological disorder.
According to the national norm results, if the total score > 160, or the number of positive items > 43, or one factor score >2, we consider the positive screening.
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Heng-Li Tian, M.D., Ph.D., Shanghai 6th People's Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2012
Primær færdiggørelse (Faktiske)
1. april 2014
Studieafslutning (Faktiske)
1. maj 2014
Datoer for studieregistrering
Først indsendt
10. juni 2014
Først indsendt, der opfyldte QC-kriterier
10. juni 2014
Først opslået (Skøn)
11. juni 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. august 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. august 2020
Sidst verificeret
1. august 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 658214
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Mild traumatisk hjerneskade
-
University of California, Los AngelesAfsluttetAlzheimers sygdom | Mild kognitiv svækkelse | Dyb hjernestimulation | Brain ImagingForenede Stater