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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; TBI; Anoxia-Ischemia, Brain; Acquired Brain Injury Including Stroke
• Intervention / Treatment: Device: verum tRNS + Neurofeedback; Device: sham tRNS + Neurofeedback

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alice Barra, PhD; Phone Number: +34 625937357; Email: alice.barra@irenea.es

Study Locations

• Spain
  • Valencia
    • Valencia, Valencia, Spain, 46007
      • Recruiting
      • Hospitales Vithas
      • Contact: Alice Barra; Phone Number: + 34 625937357; Email: alice.barra@irenea.es
      • Contact: Maria Dolores Navarro; Email: lolesnavarro@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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
Sham Comparator: 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).	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral effectiveness of tRNS + NF on attention measures - CCPT	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	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	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	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	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfer to daily life and perceived effectiveness - PGIC	The Patient's Global Impression of Change is a short questionnaire composed of two questions about the patient's perception of change related to his/her symptoms. One question is rated 1 to 7 (Likert scale) and the other one is rated 0 to 10.	The PGIC questionnaire will be provided to participants post-intervention (within 3 weeks of the end of the treatment)
Motivation of tRNS + NF training compared to standard cognitive rehabilitation	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	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

Collaborators and Investigators

• Sponsor: Hospitales Nisa

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 7, 2026
• First Submitted That Met QC Criteria: September 11, 2026
• First Posted (Actual): September 14, 2026

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: neurofeedback; cognitive rehabilitation; neuromodulation; neurorehabilitation; non invasive brain stimulation; acquired brain injury; tRNS; attentional deficits
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Brain Ischemia; Signs and Symptoms, Respiratory; Craniocerebral Trauma; Trauma, Nervous System; Hypoxia, Brain; Hypoxia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Brain Injuries; Hypoxia-Ischemia, Brain; Therapeutics; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Biofeedback, Psychology; Feedback, Psychological; Neurofeedback
• Other Study ID Numbers: NeMoRe_Phase_II; CIAPOS/2024/207 (Other Grant/Funding Number: GENERALITAT VALENCIANA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No