NCT04290988

Circuitry Assessment and Reinforcement Training Effects on Recovery

Circuitry Assessment and Reinforcement Training Effects on Recovery (CARTER)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates if electroencephalography (EEG) neurofeedback training is more beneficial than sham feedback training for the improvement of communication, anxiety, and sleep quality in individuals with aphasia. Half of the participants will receive active EEG neurofeedback sessions first, followed by sham feedback sessions in a crossover design. The other half of participants will undergo sham feedback sessions first, followed by active neurofeedback.

Detailed description

Neurofeedback, a form of biofeedback, provides a visual and/or audio representation of an individual's neural electrical activity from live EEG recording. Using operant conditioning principles, individuals are trained to increase or reduce patterns of brainwave activity to modify behavior and performance. Although neurofeedback has not yet been investigated as a treatment for aphasia or other communication deficits due to stroke or neurodegenerative disease, it may be effective. Previous studies have observed improvement in cognitive and behavioral measures in those with conditions such as Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder. Furthermore, it has been associated with reduced anxiety and sleep disruption, which both exacerbate language and communication impairments. Research is needed to determine if neurofeedback may be an effective treatment for language disorders such as PPA and post-stroke communication disorders. It is possible that EEG neurofeedback, which focuses on improving abnormal brainwave patterns, could provide certain therapeutic benefits to individuals with PPA or post-stroke aphasia, either by directly affecting neural networks that underlie language, or more generally by reducing anxiety and inattention through behavioral conditioning. Reduction of anxiety in neurological diseases can be beneficial not only for functional performance but also sleep duration and quality.

Conditions

• Aphasia
• Primary Progressive Aphasia
• Stroke

Interventions

Type	Name	Description
DEVICE	EEG Neurofeedback	Active EEG neurofeedback
DEVICE	Sham Feedback	Sham EEG feedback sessions identical to active sessions except that the feedback given to the participant will not be based on the individual's live EEG activity.

Timeline

• Start date: 2020-09-23
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2020-03-02
• Last updated: 2026-02-05
• Results posted: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study