Toward a Generalizable Closed-loop Neurofeedback-based BCI for Attention Training

NCT05908253 | Completed DMC

• 1 other identifier: URhodeIsland
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study accelerates the translational aspect of neurofeedback-based attention training using novel technologies, algorithms, and neuromarkers. The presented brain training intervention and approaches will not only be applicable to attention remedy in patients with attention deficits but also can be applied to treatment of other neurocognitive (mental) disorders such as anxiety, depression, and addiction.

Conditions

Neurofeedback

Outcome Measures

Primary Outcomes (1)

• Accuracy of behavioral performance measured by push buttons in response to stimuli

  This outcome focuses on the effectiveness of closed-loop algorithms for neurofeedback-based attention training. The behavioral responses to instructed stimuli before and after closed-loop neurofeedback will be measured by push buttons and will be evaluated.

  12 months

Study Arms (3)

sham neurofeedback

SHAM COMPARATOR

Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop sham neurofeedback protocol.

Behavioral: sham neurofeedback

nonadaptive neurofeedback

ACTIVE COMPARATOR

Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop nonadaptive neurofeedback protocol. In this method, the stimuli is changed using the upcoming neural activity and an open-loop attention model of the corresponding human subject.

Behavioral: nonadaptive neurofeedback

adaptive neurofeedback

ACTIVE COMPARATOR

Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop adaptive neurofeedback protocol. In this method, the stimuli is changed using the upcoming neural activity and an adaptive algorithm.

Behavioral: adaptive neurofeedback

Interventions

sham neurofeedback BEHAVIORAL

Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop sham neurofeedback protocol.

sham neurofeedback

nonadaptive neurofeedback BEHAVIORAL

Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop nonadaptive neurofeedback protocol. In this method, the stimuli is changed using the upcoming neural activity and an open-loop attention model of the corresponding human subject.

nonadaptive neurofeedback

adaptive neurofeedback BEHAVIORAL

Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop adaptive neurofeedback protocol. In this method, the stimuli is changed using the upcoming neural activity and an adaptive algorithm.

adaptive neurofeedback

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged over 18 years
• No prior medical record of brain damage
• No prior diagnosis of mental issue
• Ample physical condition to push buttons / keywords

You may not qualify if:

• Clinical diagnosis of Alzheimer's Disease or other mental issues
• Medical record of brain damage
• Upper limb physical disability

Sponsors & Collaborators

• University of Rhode Island: lead

Study Sites (1)

University of Rhode Island

Kingston, Rhode Island, 02881, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: June 18, 2023
• Study Start: December 16, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)