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Effects of Neurofeedback Training and tRNS on Attentional Deficits in Patients With Acquired Brain Injury (NeMoRe II)

11 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Dispositivo: verum tRNS + Neurofeedback

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
Comparador Falso: 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).
Dispositivo: sham tRNS + Neurofeedback

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Behavioral effectiveness of tRNS + NF on attention measures - CCPT
Prazo: 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)
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
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)
Behavioral effectiveness of tRNS + NF on attention measures - Digit Span
Prazo: 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)
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
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)
Behavioral effectiveness of tRNS + NF on attention measures - D2-R
Prazo: 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)
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.
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)
electrophysiological effectiveness of tRNS+ NF - EEG power and connectivity
Prazo: 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)
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).
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)
electrophysiological effectiveness of tRNS + NF - P300 ERP
Prazo: 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)
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.
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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Transferência para a vida diária e a eficácia percebida - PGIC
Prazo: O questionário PGIC será fornecido aos participantes após a intervenção (dentro de 3 semanas após o final do tratamento)
A impressão global de mudança do paciente é um breve questionário composto por duas perguntas sobre a percepção de mudança do paciente relacionada aos seus sintomas. Uma pergunta é classificada de 1 a 7 (escala Likert) e a outra é classificada de 0 a 10.
O questionário PGIC será fornecido aos participantes após a intervenção (dentro de 3 semanas após o final do tratamento)
Motivation of tRNS + NF training compared to standard cognitive rehabilitation
Prazo: The IMI questionnaire will be filled in at T1 (post-intervention, within 3 weeks of the end of the treatment)
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.
The IMI questionnaire will be filled in at T1 (post-intervention, within 3 weeks of the end of the treatment)
Side effects and adverse events of the intervention
Prazo: This information will be collected in the case report form during and after each session
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).
This information will be collected in the case report form during and after each session

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hospitales Nisa

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

26 de junho de 2026

Conclusão Primária (Estimado)

1 de outubro de 2027

Conclusão do estudo (Estimado)

1 de outubro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

7 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de setembro de 2026

Primeira postagem (Real)

14 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NeMoRe_Phase_II
  • CIAPOS/2024/207 (Número de outro subsídio/financiamento: GENERALITAT VALENCIANA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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