Circuitry Assessment and Reinforcement Training Effects on Recovery

Johns Hopkins University7 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Aphasia Primary Progressive Aphasia Stroke

Interventions

EEG NeurofeedbackDEVICE

Active EEG neurofeedback

Sham FeedbackDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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. The score range is 0 - 175 (higher scores reflect more accurate naming/better naming ability)

Time frame: Baseline, 1 week following each intervention period

Secondary Outcomes

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.

Time frame: Baseline, 1 week following each intervention period

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.

Time frame: 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 (worse) anxiety. STAI Part 1 Score range 20-80 and STAI Part 2 score range 20-80 with higher scores representing greater (worse) anxiety.

Time frame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods

Change in Sleep Medication Dosage

Change in number of doses of sleep medication taken per week

Time frame: Baseline, 1 week following each intervention period

Data from ClinicalTrials.gov

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