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临床试验/NCT02957695
NCT02957695已完成不适用

Neurofeedback in Patients With Frontal Brain Lesions: Randomised Controlled Double-blind Trial

PD Dr. med. Margret Hund-Georgiadis2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Change in frontal brain function assessed by the Emotion recognition Test

研究概览

简要总结

In this randomized double-blind controlled study we would like to test the benefit of neurofeedback for the recovery of patients with frontal brain injury during an early stage of neurorehabilitation.

详细描述

Aim of the study: Patients with a frontal brain lesion often suffer from deficits in brain functions like attention, concentration, planning, impulse control and emotional stability. In this study the investigators would like to test, whether neurofeedback as a non-medication option can help to improve these cognitive functions. Neurofeedback is a method for optimization and stabilization of the brain activity. The brain continuously gets computer-based information about its state. This information is used by the brain for self-regulation. Because neurofeedback is a process based on learning, the positive effects can be integrated into the daily life and seem to persist also after the training stopped. From the literature, several studies have shown promising results of neurofeedback therapy in patients with brain injuries, but no study so far fulfills the scientific criteria which proves a benefit. Methods: The selection of potential study participants is made by the senior or chief physician. Totally, we include 20 patients with a newly acquired frontal brain lesion. 10 patients receive normal neurofeedback training and 10 patients receive a placebo-neurofeedback in a randomized, double blinded manner. In total, 20 neurofeedback sessions are conducted. At the beginning, after 10 sessions and at the end of the intervention time, a neuropsychological assessment is performed to test the main cognitive functions of the frontal brain. Data analysis: The performance in the neuropsychological testing is the primary outcome. We expect that all participants will gain performance during the course of the study due to natural brain recovery, so that we will focus on the difference of the improvements between the two groups (neurofeedback and placebo-group).

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Middle to severe frontal or frontotemporal brain injury due to accident, bleeding or ischemia, assessed by the Initial Glascow-Coma-Scale from 3 to
  • Time between the injury and inclusion into the study should be 1-6 months
  • The participants must be able to perform simple neuropsychologic tests including sufficient vigilance and motor function for pressing a button.
  • There is no age limitation. The patients who are hospitalized in the REHAB for a initial rehabilitation have a minimum age of 18 years.
  • signed consent form

排除标准

  • therapy-resistant symptomatic epilepsy
  • severe cognitive deficits, which do not allow understanding of the required neuropsychological tests, e.g. sensory aphasia.
  • preexisting dementia
  • progressive cerebral diseases e.g. multiple sclerosis, brain tumor
  • schizophrenia

结局指标

主要结局

Change in frontal brain function assessed by the Emotion recognition Test

时间窗: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention

Change in the Emotion recognition Test (T-values) assessed before, after 4 weeks of intervention and after 8 weeks of intervention

Change in frontal brain function assessed by the GoNogo-Test

时间窗: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention

Change in the GoNogo-Test (T-values) assessed before, after 4 weeks of intervention and after 8 weeks of intervention

Change in frontal brain function assessed by Alertness Test

时间窗: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention

Change in the Alertness Test (T-values) assessed before, after 4 weeks of intervention and after 8 weeks of intervention

Change in frontal brain function assessed by FAB (Frontal assessment battery) scale

时间窗: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention

1\. Change in the FAB scale (point score) assessed before, after 4 weeks of intervention and after 8 weeks of intervention

次要结局

  • Change in quantitative eeg z-scores of coherence and relative power(Assessment is made before and after 8 weeks of intervention)
  • Change in behaviour assessed by the Frontal Systems Behavioral Scale (FrSBe)(Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention)

研究者

发起方
PD Dr. med. Margret Hund-Georgiadis
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

PD Dr. med. Margret Hund-Georgiadis

PD Dr. med.

Rehab Basel

研究点 (2)

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