Effects of Neurofeedback Training and tRNS on Attentional Deficits in Patients With Acquired Brain Injury

NCT07817316 | Recruiting

• 2 other identifiers: NeMoRe_Phase_IICIAPOS/2024/207
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TBI; Acquired Brain Injury Including Stroke; Stroke; Anoxia-Ischemia, Brain

Keywords

neuromodulation; neurorehabilitation; acquired brain injury; neurofeedback; tRNS; non invasive brain stimulation; attentional deficits; cognitive rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Motivation of tRNS + NF training compared to standard cognitive rehabilitation

  The IMI questionnaire will be filled in at T1 (post-intervention, within 3 weeks of the end of the treatment)

• Transfer to daily life and perceived effectiveness - PGIC

  The PGIC questionnaire will be provided to participants post-intervention (within 3 weeks of the end of the treatment)

• Side effects and adverse events of the intervention

  This information will be collected in the case report form during and after each session

Study Arms (2)

Group A ( verum tRNS + NF)

ACTIVE COMPARATOR

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

Group B (sham tRNS + NF)

SHAM COMPARATOR

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

Interventions

verum tRNS + Neurofeedback DEVICE

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

Group A ( verum tRNS + NF)

sham tRNS + Neurofeedback DEVICE

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

Group B (sham tRNS + NF)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• previous report of psychiatric and/or neurologic disorders
• contraindication to computerized activities
• blindness or severe visual impairments

Sponsors & Collaborators

• Hospitales Nisa: lead

Study Sites (1)

Hospitales Vithas

Valencia, Valencia, 46007, Spain

RECRUITING

MeSH Terms

Conditions

Stroke; Hypoxia-Ischemia, Brain; Brain Injuries

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Hypoxia, Brain; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Central Study Contacts

Alice Barra, PhD

CONTACT

+34 625937357; alice.barra@irenea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Two researchers will be solely responsible for randomisation and group allocation. They will not participate in clinical assessments or intervention delivery. The device manufacturer has provided a list of codes corresponding to active and sham stimulation programs. These codes do not reveal the stimulation condition (e.g., 61-1-HV9-2). The two researchers will generate the randomisation sequence using Random.org, in blocks of six participants (three active, three sham). Each position will then be linked to a manufacturer code and stored in a confidential database accessible only to them. After informed consent, the PI will provide The two researchers with the participant ID. They will return the corresponding stimulation code, which will be entered into the device at the time of intervention. All researchers involved in assessments and intervention delivery will remain blinded to the stimulation condition throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director or Research MD PhD

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 14, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)