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

11 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Comparatore fittizio: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Behavioral effectiveness of tRNS + NF on attention measures - CCPT
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Trasferimento alla vita quotidiana e efficacia percepita - PGIC
Lasso di tempo: Il questionario PGIC sarà fornito ai partecipanti dopo l'intervento (entro 3 settimane dalla fine del trattamento)
L'impressione globale del cambiamento del paziente è un breve questionario composto da due domande sulla percezione del cambiamento del paziente relative ai suoi sintomi. Una domanda è classificata da 1 a 7 (scala Likert) e l'altra è valutata da 0 a 10.
Il questionario PGIC sarà fornito ai partecipanti dopo l'intervento (entro 3 settimane dalla fine del trattamento)
Motivation of tRNS + NF training compared to standard cognitive rehabilitation
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hospitales Nisa

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 giugno 2026

Completamento primario (Stimato)

1 ottobre 2027

Completamento dello studio (Stimato)

1 ottobre 2027

Date di iscrizione allo studio

Primo inviato

7 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 settembre 2026

Primo Inserito (Effettivo)

14 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NeMoRe_Phase_II
  • CIAPOS/2024/207 (Altro numero di sovvenzione/finanziamento: GENERALITAT VALENCIANA)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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