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临床试验/CTRI/2024/10/076089
CTRI/2024/10/076089尚未招募不适用

Cognitive impairment in persons with drug resistant epilepsy and correlation with homocysteine, pyridoxine, folic acid, cyanocobalamine and BDNF levels.

AIIMS, New Delhi2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
135
试验地点
2
主要终点
Neurocognitive assessment using Montreal cognitive assessment (MoCA)scale, Addenbrooke’s Cognitive Examination-III (ACE-III) Scale, Mini-Mental State Examination (MMSE) Scale

研究概览

简要总结

Cognitive decline is a major disability comorbidity in persons with epilepsy. This is particularly true in patients with drug epilepsy on multiple anti seizure drugs. It has been hypothesised that neuroinflammation can be a contributor to epilepsy development, as well as epilepsy related comorbidities. Besides inflammatory pathways, other potential causes are oxidative stress, hyperhomocysteinemia , and BDNF.  Hyperhomocysteinemia leads to the development of neurotoxicity. BDNF is an important regulatory protein in neurodevelopment, synaptogenesis and neurogenesis. Altered BDNF and homocysteine levels can be causative factors in refractory seizures and cognitive decline. Since group B vitamins like pyridoxine, folic acid and cyanocobalamine are cofactors for homocysteine metabolism, disturbance in homocysteine will be associated with changes in their levels. These can serve as potential targets for therapeutic intervention.

This study is planned to explore the extent of cognitive impairment in persons with drug resistant epilepsy on anti-seizure drugs, as well as correlation with BDNF, homocysteine, pyridoxine, folic acid and cyanocobalamine. Eligible participants will be enrolled for the study on the basis of inclusion and exclusion criteria. Participants will undergo cognitive evaluation to assess cognitive domains using cognitive assessment scales like MoCA, ACEIII, MMSE and MINI. Also, blood samples of the participants will be taken for the estimation of BDNF, homocysteine, pyridoxine, folic acid and cyanocobalamine. These will then be correlated with cognitive impairment using statistical tools.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Persons with Drug Resistant Epilepsy diagnosed as per ILAE criteria
  • Subjects willing to participate and able to provide written informed consent.
  • Subjects with basic understanding of Hindi or English.

排除标准

  • Participants who are unwilling to participate and do not provide written informed consent.
  • Alcohol consumption.
  • Pregnant and lactating women.
  • History of other chronic communicable/ noncommunicable, medical illness.

结局指标

主要结局

Neurocognitive assessment using Montreal cognitive assessment (MoCA)scale, Addenbrooke’s Cognitive Examination-III (ACE-III) Scale, Mini-Mental State Examination (MMSE) Scale

时间窗: At baseline

and MINI cognition scale.

时间窗: At baseline

Serum biomarkers for BDNF, homocysteine, pyridoxine, folic acid and cyanocobalamine.

时间窗: At baseline

次要结局

  • To assess domain wise cognitive impairment(During statistical analysis)

研究者

发起方
AIIMS, New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Jatinder Katyal

All India Institute of Medical Sciences New Delhi

研究点 (2)

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