Circuitry Assessment and Reinforcement Training Effects on Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-23

Study Completion Date

2025-09-01

Brief Summary

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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.

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Detailed Description

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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

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Aphasia Primary Progressive Aphasia Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

To evaluate the effects of EEG neurofeedback on communication skills in participants with post-stroke aphasia and primary progressive aphasia (PPA), this study will utilize a randomized double-blind, sham-controlled, within-subject crossover trial design.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active EEG Neurofeedback

15 sessions of active EEG neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.

Group Type EXPERIMENTAL

EEG Neurofeedback

Intervention Type DEVICE

Active EEG neurofeedback

Sham Feedback

15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.

Group Type SHAM_COMPARATOR

Sham Feedback

Intervention Type DEVICE

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.

Interventions

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EEG Neurofeedback

Active EEG neurofeedback

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of PPA or aphasia secondary to stroke and presence of naming deficits with confirmation of diagnosis by neurologist
* Capable of giving informed consent or indicating another to provide informed consent
* Age 18 or older.
* If aphasia is secondary to stroke, the stroke must have occurred between 6 months and 5 years prior to enrollment in the study.

Exclusion Criteria

* Lack of English proficiency
* Not medically stable
* Picture naming accuracy above 80% on the Philadelphia Naming Test (PNT)
* Prior history of neurologic disease affecting the brain (e.g., brain tumor, multiple sclerosis, traumatic brain injury) other than stroke or PPA and its underlying neurological pathologies: Alzheimer's Disease, Frontotemporal Lobar Degeneration or Dementia with Lewy bodies
* Prior history of severe psychiatric illness, developmental disorders or intellectual disability (e.g., PTSD, major depression, bipolar disorder, schizophrenia, obsessive compulsive disorder (OCD), autism spectrum disorders)
* Uncorrected severe visual loss or hearing loss by self-report and medical records

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No