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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• ≥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)

Locations
Other Locations
Spain
Hospitales Vithas
RECRUITING
Valencia
Contact Information
Primary
Alice Barra, PhD
alice.barra@irenea.es
+34 625937357
Time Frame
Start Date: 2026-06-26
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 30
Treatments
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.
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).
Related Therapeutic Areas
Sponsors
Leads: Hospitales Nisa

This content was sourced from clinicaltrials.gov