Circuitry Assessment and Reinforcement Training Effects on Recovery

Study Overview
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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.

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.

Official Title
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Circuitry Assessment and Reinforcement Training Effects on Recovery (CARTER)

Conditions
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Aphasia, Primary Progressive Aphasia, Stroke

Intervention / Treatment
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* Device: EEG Neurofeedback
* Device: Sham Feedback


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active EEG Neurofeedback<br>15 sessions of active EEG neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks. | Device: EEG Neurofeedback<br>* Active EEG neurofeedback<br>|
| Sham Comparator: Sham Feedback<br>15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks. | Device: Sham Feedback<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of content units expressed in the Picture Description Test | Change in Number of content units expressed by the participant when describing what is seen in a picture. | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of items correctly named on the Philadelphia Naming Test | Change in number of items correctly named on a behavioral picture naming assessment. | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 
| Change in Controlled Oral Word Association test (COWA) score | This is a measure of attention, executive function, and word-retrieval. COWA scores range from 0 to infinity. Lower scores represent more language impairment. | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 
| Change in quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) | Change in quality of sleep measured with The Pittsburgh Sleep Quality Index (PSQI). This has 7 items with each item scored from 0 to 3. Overall score ranges from 0 to 21 with higher scores representing poor sleep quality. | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 
| Change in anxiety as assessed by the State Trait Anxiety Inventory (STAI) | Change in anxiety measured with State Trait Anxiety Inventory. This is a 40-item questionnaire scored on a 4 point likert scale (1-4). Overall score ranges from 40 to 160 with higher scores representing greater anxiety. | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 
| Change in Sleep Medication Dose | Change in dose of sleep medication. | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 
| Change in Sleep Medication Frequency | Change in frequency of sleep medication. | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 
| Change in absolute power on EEG | Measurement of brainwave activity (absolute power in microvolts) in each frequency band (alpha, beta, theta, delta, gamma) on Quantitative EEG (qEEG). | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 
| Change in peak amplitude frequency on EEG | Measurement of brainwave activity (peak amplitude frequency in hertz) in each frequency band (alpha, beta, theta, delta, gamma) on qEEG. | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 
| Change in EEG absolute power z-scores | Comparison of z-scores for absolute power in each of the frequency bands (alpha, beta, theta, delta, gamma) pre- and post-interventions. | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 
| Change in EEG peak amplitude frequency z-scores | Comparison of z-scores for peak amplitude frequency in each of the frequency bands (alpha, beta, theta, delta, gamma) pre- and post-interventions. | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 
| Change in EEG coherence z-scores | Comparison of z-scores for coherence between EEG sites in each of the frequency bands (alpha, beta, theta, delta, gamma). | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurofeedback, communication, language, speech, anxiety, sleep