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

NCT ID: NCT06863025

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-10-01

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.

In the present study, the investigators will evaluate the effects of neurofeedback as a therapy for attentional deficits after brain injury. Participants undergoing neurofeedback and cognitive therapy will be compared to participants only receiving cognitive therapy.

Conditions

Brain Injuries; Attention Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neurofeedback

This group will receive 12 sessions of neurofeedback (20 minutes each session) targeting beta and theta. The neurofeedback protocol will aim at increasing frequencies between 16-25 and decreasing 4-7 Hz

Group Type: EXPERIMENTAL

Neurofeedback training

Intervention Type: BEHAVIORAL

Neurofeedback (NF) or electroencephalographic feedback (EEG) training refers to a type of computerized cognitive training that changes EEG patterns through operant conditioning. NF is a computerized rehabilitation technique but also a non-invasive neuromodulation approach, as it alters brain activity by delivering a stimulus. It is well-established for the treatment of conditions such as anxiety and ADHD. During NF rehabilitative training, the subject is provided with real-time EEG feedback, usually with a visual or auditory stimulus, with the aim of normalizing brain oscillations. Rehabilitation through NF training generally targets EEG frequencies that are affected and underlie the observed behavioral deficit (e.g., attentional dysfunctions).

Control

This group will receive 12 sessions of standard practice cognitive therapy (20 minutes each session) targeting attentional deficits.

Group Type: ACTIVE_COMPARATOR

Standard cognitive therapy

Intervention Type: BEHAVIORAL

This is the control intervention and it involves standard practice cognitive therapy in neurorehabilitation. Neuropsychologists and other clinicians test and train the patients' cognitive specific aspect (in this case, attention) with some validated tools and/or games

Interventions

Neurofeedback training

Neurofeedback (NF) or electroencephalographic feedback (EEG) training refers to a type of computerized cognitive training that changes EEG patterns through operant conditioning. NF is a computerized rehabilitation technique but also a non-invasive neuromodulation approach, as it alters brain activity by delivering a stimulus. It is well-established for the treatment of conditions such as anxiety and ADHD. During NF rehabilitative training, the subject is provided with real-time EEG feedback, usually with a visual or auditory stimulus, with the aim of normalizing brain oscillations. Rehabilitation through NF training generally targets EEG frequencies that are affected and underlie the observed behavioral deficit (e.g., attentional dysfunctions).

Intervention Type: BEHAVIORAL

Standard cognitive therapy

This is the control intervention and it involves standard practice cognitive therapy in neurorehabilitation. Neuropsychologists and other clinicians test and train the patients' cognitive specific aspect (in this case, attention) with some validated tools and/or games

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horizon 2020 - European Commission

OTHER

Sponsor Role: collaborator

Hospitales Nisa

OTHER

Sponsor Role: lead

Responsible Party

Enrique Noe

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Irenea Neurorhb Sl

Valencia, Province de Valence, Spain

Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA

Valencia, Spain, Spain

Countries

Spain

Related Links

https://irenea.es/irenea-servicio-de-neurorrehabilitacion/proyectos-internacionales/nemore/

Related Info

Other Identifiers

NeMoRe

Identifier Type: -

Identifier Source: org_study_id