Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents
Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents. Relationship With Clinical and Sociodemographic Variables
調査の概要
詳細な説明
The aim of this study is to investigate the effect that the eradication of the HCV has on cognition, quality of life and psychopathology. At the same time, investigators intend to study the association between cognitive changes and some clinical variables.
The sample consists of 80 subjects (40 HCV patients and 40 HCV patients coinfected with the Human Immunodeficiency Virus, HIV). Exclusion criteria: Cirrhosis, presence of minimal hepatic encephalopathy or active drug consumption.
A neuropsychological assessment is made before the treatment with direct antiviral agents to evaluate memory, executive functions, processing speed, anxiety, depression and quality of life. Additionally, the following clinical variables are collected: Viral charge, immunosuppression (measured with T Cells CD4 (CD4), CD4 nadir and T Cells CD8 (CD8)) and fibrosis level, HCV genotype and plasma biomarkers: Brain-Derived Neurotrophic Factor (BDNF), Interleukine 6 (IL6), Tumor Necrosis Factor (TNF-a),Glial fibrillary acidic protein (GFAP), Soluble CD14 (SCD14), Neuro-specific enolase (NSE).
The second neuropsychological assessment and clinical data collection is carried out after treatment, concretely 6 months after HCV is undetectable in plasma.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients over 18 years old with indication to receive antiviral treatment
- Diagnosis of chronic infection by hepatitis C virus in the fibrous phase F3 or F4 that have not presented any clinical decompensation of their liver disease, with or without HIV co-infection
Exclusion Criteria:
- Active alcohol consumption> 40g daily or history of chronic alcoholism
- Active consumption of other toxics (heroin, cocaine, cannabis)
- Patients with minimum hepatic encephalopathy
- Background of cerebral neurological disease, chronic renal insufficiency and / or psychiatric illnesses assessed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, which can affect cognitive functions.
- Active use of psychotropics or benzodiazepines
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Memory tests
時間枠：baseline, change at 6 months after treatment
|
Rey Auditory Verbal Learning Test (RVLT, Spreen & Strauss 1998) assesses verbal learning, recall and recognition memory; Wechsler Adults Intelligence Scale III backward digits subtest (WAIS, Wechsler 1997) assesses working memory.
All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single memory component.
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baseline, change at 6 months after treatment
|
|
Attention tests
時間枠：baseline, change at 6 months after treatment
|
Continous Performance Test (CPT, Conners 2000) assesses sustained attention, inattentiveness and impulsivity; WAIS forward digits subtest (WAIS III, Wechsler 1997) assesses attention.
All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single attention component.
|
baseline, change at 6 months after treatment
|
|
Executive function tests
時間枠：baseline, change at 6 months after treatment
|
Stroop Test (Stroop, 1935) assesses flexibility and inhibition of automatic responses; Trail Making Test (TMTA-B Reitan, 1993) assesses visual tracking and flexibility, phonetic and semantic fluency tests (Lezak, 1995) assess verbal fluency; Tower of London (Culbertson & Zillmer, 2005) assesses visual reasoning and planification.
All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single executive function component.
|
baseline, change at 6 months after treatment
|
|
Speed processing test
時間枠：baseline, change at 6 months after treatment
|
Digit symbol test (WAIS III, Wechsler 1997) assesses visuomotor speed.
The direct scores have been transformed into T-scores (mean=50; SD=10).
|
baseline, change at 6 months after treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
時間枠：baseline, change at 6 months after treatment
|
It is a self-registering scale of 14 items: 7 items evaluating anxiety and 7 items evaluating depression (Zigmond & Snaith, 1983). Scoring range: 0-21 for each subscale. Scores >10 in each subscale imply a significant anxious/depressive symptomatology. |
baseline, change at 6 months after treatment
|
|
36-Item Short Form Health Survey (SF-36 )
時間枠：baseline, change at 6 months after treatment
|
It is a self-registered scale for the assessment of quality of life ( Alonso y cols.
, 1995).
It consists on 8 dimensions: Physical functioning, limitations for physical issues, corporal pain, social functioning, mental health, limitations for emotional issues, vitality and general perception of the own health.
For each dimension, the scoring range goes from 0 to 100, where higher values represent better outcome (better quality of life/less limitations/better functioning).
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baseline, change at 6 months after treatment
|
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Fibroscan
時間枠：Baseline, change at 6 months after treatment
|
Degree of fibrosis: Speed of propagation of elastic waves measured with fibroscan.
|
Baseline, change at 6 months after treatment
|
|
HCV RNA
時間枠：Baseline, change at 3 months after treatment, change at 6 months after treatment.
|
Viral load quantity measured by plasma HCV RNA is collected in HIV co-infected patients
|
Baseline, change at 3 months after treatment, change at 6 months after treatment.
|
|
Immunosuppression state
時間枠：Baseline
|
The next cells were analyzed in blood, in HIV co-infected patients : CD4, %CD4, nadir CD4, CD8, % CD8, CD4/CD8 ratio.
|
Baseline
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood Biomarkers measures
時間枠：1 day pretreatment and change at 6 months post treatment
|
The next blood biomarkers were collected: Brain-derived neurotrophic factor (BDNF); Interleukine 6 (Il-6); Tumor Necrosis Factor (TNF-a ); Glial fibrillary acidic protein (GFAP); Soluble SCD 14 (sCD14) ; Neuro-specific enolase (NSE).
|
1 day pretreatment and change at 6 months post treatment
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CIR2015/042
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