Effects of Neurofeedback Training and tRNS on Attentional Deficits in Patients With Acquired Brain Injury (NeMoRe II)
2026年9月11日 更新者：Enrique Noe、Hospitales Nisa
The goal of this study is to investigate new neuromodulation therapies for attention deficits following acquired brain injury.
Brain damage can affect various domains, including motor and cognitive functions.
However, cognitive deficits have many consequences on the functionality and independence of patients, and attention is an essential requirement for most of daily activities.
After brain damage, cognitive rehabilitation is generally the first treatment option for attention deficits.
Some studies have shown that cognitive rehabilitation is sometimes not very effective.For this reason, new therapies such as neuromodulation techniques are being investigated.
Neurofeedback is a non-invasive neuromodulation therapy involving a type of computer-based training and learning, and some studies have shown that it is a promising tool to treat cognitive deficits in patients with brain injuries.
Transcranial electrical stimulation (tES) is also used to modulate spontaneous brain activity.
In the present study, the investigators will evaluate the effects of tES combined with neurofeedback as a therapy for attentional deficits after brain injury.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Alice Barra, PhD
- 电话号码：+34 625937357
- 邮箱：alice.barra@irenea.es
学习地点
-
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Valencia
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Valencia、Valencia、西班牙、46007
- 招聘中
- Hospitales Vithas
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接触：
- Alice Barra
- 电话号码：+ 34 625937357
- 邮箱：alice.barra@irenea.es
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接触：
- Maria Dolores Navarro
- 邮箱：lolesnavarro@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- ≥18 years old
- ABI resulting from TBI, stroke, hypoxia and other etiologies
- attentional deficits that are among the objectives of neurorehabilitation as established by the clinical team (scores falling in the 90% percentiles on the Conner's Continuous Performance - CCPT, on the Digit and Spatial Span Tasks and Color Trail test)
- good cognitive condition (ie., scores of ≥23 in the Mini Mental State Examination
- MMSE or ≥75 in the Galveston Orientation & Amnesia Test - GOAT)
Exclusion Criteria:
- previous report of psychiatric and/or neurologic disorders
- contraindication to computerized activities
- blindness or severe visual impairments
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Group A ( verum tRNS + NF)
Participants allocated to this group will receive 12 sessions of intervention for the cognitive rehabilitation of attentional deficits.
The intervention will include 10 minutes of tRNS stimulation in the 16-25 Hz range and then 20 minutes of Neurofeedback training positively reinforcing 16-25 Hz (beta) and negatively reinforcing 4-7 Hz (theta).
tRNS has the followign characteristics: intensity of 1000 µA (±, 2000 µA peak-to-peak); white noise, band-pass 16-25 Hz.
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The neuromodulation intervention will have the following characteristics: each session will last 1 hour; 10 minutes of tRNS will precede 20 minutes of NF, with approximately 20 minutes for setting up the system and measuring impedances until the NF signal reaches optimal quality, and 10 minutes for removing the equipment. The tRNS will deliver a biphasic sinusoidal random noise current (tRNS) with an amplitude of 2 mA within the 16-25 Hz frequency range, using electrodes placed over F3 and F4. To administer tES, we will use a portable device from the Neurocare Group, which produces neuromodulation devices for research and clinical applications and has CE approval (Neurocare DC-STIMULATOR MOBILE). The NF will reinforce the 16-25 Hz frequency range and will consist of an EEG-based visual task, i.e., a video that decreases or increases in size according to the β levels detected at Fz. For NF, we will use a device from Thought Technology, the ProComp 2, together with Biograph Infinity |
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假比较器：Group B (sham tRNS + NF)
Participants allocated to this group will receive 12 sessions of intervention for the cognitive rehabilitation of attentional deficits.
The intervention will include 10 minutes of tRNS sham stimulation with a 30 seconds ramp up and ramp down and then 20 minutes of Neurofeedback training positively reinforcing 16-25 Hz (beta) and negatively reinforcing 4-7 Hz (theta).
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The intervention will have the following characteristics: each session will last 1 hour; 10 minutes of tRNS will precede 20 minutes of NF, with approximately 20 minutes for setting up the system and measuring impedances until the NF signal reaches optimal quality, and 10 minutes for removing the equipment. The sham tRNS will deliver a biphasic sinusoidal random noise current (tRNS) with for 30 seconds and then will automatically turn off. To administer tES, we will use a portable device from the Neurocare Group, which produces neuromodulation devices for research and clinical applications and has CE approval (Neurocare DC-STIMULATOR MOBILE). The NF will reinforce the 16-25 Hz frequency range and will consist of an EEG-based visual task, i.e., a video that decreases or increases in size according to the β levels detected at Fz. For NF, we will use a device from Thought Technology, the ProComp 2, together with Biograph Infinity |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Behavioral effectiveness of tRNS + NF on attention measures - CCPT
大体时间：The CCPT will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)
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The Conners Continuous Performance Test (CCPT ) is a computer administered test designed to assess problems with attention.
It presents 360 stimuli trials (i.e., individual letters) on the screen, with 1, 2, or 4 seconds intervals between the presentatio
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The CCPT will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)
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Behavioral effectiveness of tRNS + NF on attention measures - Digit Span
大体时间：The Digit Span test will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)
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The digit span test is a very short test that evaluates a person's cognitive status that initially was part of Wechsler's Intelligence Scale.
It consists of telling the participant a series of numbers and ask him to repeat them back to you in the same order you say them.
The first series are composed of three numbers, the next series four numbers, then five etc.
The series are repeated until one incorrect answer is observed.
Both the digit and spatial span tests are frequently used in hospitals and physicians' offices in order for a clinician to quickly evaluate whether a person's cognitive abilities are normal or impaired
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The Digit Span test will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)
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Behavioral effectiveness of tRNS + NF on attention measures - D2-R
大体时间：The D2-R test will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)
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The d2-R measures the ability to concentrate and sustain attention.
It consists of picking out target symbols, from among similar symbols, under pressure of time.
The participant is asked to search for and mark certain target symbols (ie., the letter "d" with two dashes).
The test itself consists of 14 screens in succession, each having 60 symbols laid out in six rows of ten.
All instances of "d" with two dashes are to be marked.
The instruction is to work quickly, without making mistakes.
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The D2-R test will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)
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electrophysiological effectiveness of tRNS+ NF - EEG power and connectivity
大体时间：The EEG resting state will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)
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EEG analyses are based on the recording of EEG signal, which is the sum of neuronal activity, mainly post-synaptic, represented on a time axis.
Based on EEG we will be able to perform analyses on qEEG, connectivity between regions.
We will use BrainVision system for EEG recording of 10 minutes of resting state (5 minutes eyes open, 5 minutes eyes closed).
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The EEG resting state will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)
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electrophysiological effectiveness of tRNS + NF - P300 ERP
大体时间：The P300 will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)
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The P300 is a component of an event-related potential (ERP), which is a measurable brain response to a specific stimulus.
It typically occurs around 300 milliseconds after the presentation of a stimulus that is unexpected, infrequent, or relevant.
It is often used in cognitive neuroscience to study attention and decision-making processes.
It is detected using EEG and often uses tasks like the "oddball paradigm," where subjects are asked to detect infrequent target stimuli among frequent non-targets, to elicit the P300 response.
P300 will be assessed with an auditory oddball paradigm built using Eprime and Brain Vision EEG system.
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The P300 will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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转移到日常生活和感知的有效性-PGIC
大体时间：PGIC问卷将在干预后向参与者提供（在治疗结束后的3周内）
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患者对全球变化的印象是一份简短的问卷，其中包括两个有关患者对他/她症状有关的变化感知的问题。
一个问题的评分为1至7（李克特量表），另一个问题为0到10。
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PGIC问卷将在干预后向参与者提供（在治疗结束后的3周内）
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Motivation of tRNS + NF training compared to standard cognitive rehabilitation
大体时间：The IMI questionnaire will be filled in at T1 (post-intervention, within 3 weeks of the end of the treatment)
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The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.
It is composed of several subscales that measure enjoyment, perceived competence, effort, value, felt pressure, perceived choice.
The interest/enjoyment subscale is the self-report measure of intrinsic motivation.
Although research has showed that the order in which the subscales are presented is negligible, all subscales are rarely administered and researchers generally choose the subscales relevant to their study.
In the present study we will administer the items related to the interest/enjoyment subscale.
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The IMI questionnaire will be filled in at T1 (post-intervention, within 3 weeks of the end of the treatment)
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Side effects and adverse events of the intervention
大体时间：This information will be collected in the case report form during and after each session
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We will collect information on possible side effects perceived during and after each session of intervention.
Participants will be asked to report any side effect perceived during and after every session of intervention (both tRNS and NF).
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This information will be collected in the case report form during and after each session
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月26日
初级完成 (估计的)
2027年10月1日
研究完成 (估计的)
2027年10月1日
研究注册日期
首次提交
2026年9月7日
首先提交符合 QC 标准的
2026年9月11日
首次发布 (实际的)
2026年9月14日
研究记录更新
最后更新发布 (实际的)
2026年9月14日
上次提交的符合 QC 标准的更新
2026年9月11日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NeMoRe_Phase_II
- CIAPOS/2024/207 (其他赠款/资助编号：GENERALITAT VALENCIANA)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Outcome and demographical/clinical data will not be made openly available as it is sensitive data and cannot be shared on open access unrestricted platforms.
This is for legal reasons due to the fact that data might allow patient's identity to be revealed.
Behavioural and raw EEG data (without any demographical and clinical information) might be shared with other scientists privately on platforms such as ResearchGate upon reasonable requests.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.