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临床试验/NCT06517706
NCT06517706已完成不适用

Brain Research and Integrative Neuroscience Network for COVID-19 (BRAINN)

University of Cyprus2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Categorization Program Test 2

研究概览

简要总结

The aim of the experimental study is to investigate two interventions for the management of cognitive symptoms resulting from long COVID. Participants will be randomly assigned into two interventions. 1. Categorization Program (CP) training with active tDCS or 2. Categorization Program training with sham tDCS.

详细描述

The two intervention protocols (digitalized CP and NIBS) required for this study have been developed and the required equipment (one existing and three new tDCS devices) has been acquired. Recruitment for the feasibility study is planned to begin in month 18, i.e., June 2024.

Changes in the design of the feasibility study have been made by the SC and in coordination with the Advisory Board. The changes were deemed necessary to improve the original study design to capture changes in cognition due to treatment. Specifically, the feasibility study will retain the two-group design (experimental and control). Forty participants with PCS will be recruited (instead of seventy, as originally planned). All participants will undergo the diagnostic protocols (the neuroimaging and neuropsychological assessments). Then, participants will be randomly assigned into two groups: the experimental, who will receive the active tDCS and CP intervention, and the control group, who will receive the sham tDCS and CP intervention. Following the intervention, all participants (experimental and control) will complete a series of dependent measures, including neuropsychological performance and quality of life measures. For neurophysiological measures, electroencephalography (EEG) has been replaced with functional near-infrared spectroscopy (fNIRS), which will be conducted both pre- and post-intervention. The current design will require a longer intervention period (as compared to the original design) and the complete delivery of the digitalized CP to maximize treatment effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Participants will be randomly assigned to the experimental and control group. Both groups will receive cognitive rehabilitation. The experimental group control group will also active tDCS treatment whereas the control will receive inactive or sham tDCS treatment

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Reported cognitive difficulties due to COVID-19 infection
  • WHO Long COVID criteria will be used

排除标准

  • Significant history of neuropsychiatric conditions prior to contracting COVID-19; history of neurological conditions such as TBI, CVA, MS prior to contracting COVID-19.

研究组 & 干预措施

Experimental Condition

Experimental

Combination of cognitive training with active tDCS

干预措施: Categorization Program (Behavioral)

Control Condition

Sham Comparator

Combination of cognitive training with sham tDCS

干预措施: Categorization Program (Behavioral)

Experimental Condition

Experimental

Combination of cognitive training with active tDCS

干预措施: Combination of tDCS (device) with cognitive training (behavioral) (Combination Product)

结局指标

主要结局

Categorization Program Test 2

时间窗: Administered pre & post training with the Categorization Program, at 6 weeks

Decision-Making and Rule based learning

Dysexecutive Questionnaire

时间窗: pre and post training, at 6 weeks

Test of everyday executive functioning behaviors; self and informant reports

Probe Tasks

时间窗: Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks

Decision-Making and Rule based learning

Categorization Program Test 1

时间窗: Administered pre & post training with the Categorization Program, at 6 weeks

Semantic knowledge and classification behavior

WHO BREF Quality of Life

时间窗: before and after training, at 6 weeks

general quality of life

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fofi Constantinidou

Professor of Psychology

University of Cyprus

研究点 (2)

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