Clinical trial NCT06863025: Effects of Neurofeedback Training on Attentional Deficits in Patients With Acquired Brain Injury
Official title: Effects of Neurofeedback Training on Attentional Deficits in Patients With Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Brain Injuries
Attention Disorder
Keywords: neurofeedback
brain injury
attentional deficits
neuromodulation
neurorehabilitation
Lead sponsor: Hospitales Nisa
Sponsor class: OTHER
Collaborators: name: Horizon 2020 - European Commission
First posted: 2025-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups: 1)experimental will receive treatment (NF), 2) control will receive standard cognitive therapy rehabilitation. groups will be matched for numbers of treatment received
Primary purpose: TREATMENT

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.


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 \&amp; Amnesia Test - GOAT)

Exclusion Criteria:

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

Primary outcomes:
measure: Behavioral effectiveness of NF on attention measures - CCPT
timeFrame: The CCPT will be assessed during the pre-treatment assessment (within three weeks before the start of the treatment) and the post-treatment assessment (within 3 weeks of the end of the treatment)
measure: Behavioral effectiveness of NF on attention measures - Color Trail Test
timeFrame: The Color Trail Test will be assessed during the pre-treatment assessment (within three weeks before the start of the treatment) and the post-treatment assessment (within 3 weeks of the end of the treatment)
measure: Behavioral effectiveness of NF on attention measures - Digit and Spatial Span
timeFrame: The Digit and Spatial Span tests will be assessed during the pre-treatment assessment (within three weeks before the start of the treatment) and the post-treatment assessment (within 3 weeks of the end of the treatment)
measure: Behavioral effectiveness of NF on attention measures - D2-R
timeFrame: The D2-R test will be assessed during the pre-treatment assessment (within three weeks before the start of the treatment) and the post-treatment assessment (within 3 weeks of the end of the treatment)
measure: electrophysiological effectiveness of NF - EEG power and connectivity
timeFrame: The EEG resting state will be recorded during the pre-treatment assessment (within three weeks before the start of the treatment) and the post-treatment assessment (within 3 weeks of the end of the treatment)
measure: electrophysiological effectiveness of NF - P300 ERP
timeFrame: The P300 will be assessed during the pre-treatment assessment (within three weeks before the start of the treatment) and the post-treatment assessment (within 3 weeks of the end of the treatment)
Secondary outcomes:
measure: Motivation of NF training compared to standard cognitive rehabilitation
timeFrame: The IMI questionnaire will be provided to participants post-intervention (within 3 weeks of the end of the treatment)
measure: Transfer to daily life and perceived effectiveness - PGIC
timeFrame: The PGIC questionnaire will be provided to participants post-intervention (within 3 weeks of the end of the treatment)
measure: Transfer to daily life and perceived effectiveness - Moss
timeFrame: The Moss attentional questionnaire will be provided to participants post-intervention (within 3 weeks of the end of the treatment)
measure: Transfer to daily life and perceived effectiveness - GAS
timeFrame: The GAS questionnaire will be provided to participants post-intervention (within 3 weeks of the end of the treatment)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Irenea Neurorhb Sl
state: Province de Valence
city: Valencia
country: Spain
facility: Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA
Study officials:
References: