Aphasia, Primary Progressive Aphasia, Stroke
Conditions
Keywords
communication, language, speech, anxiety, sleep, neurofeedback
Brief 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.
Interventions
DEVICEEEG Neurofeedback
Active EEG neurofeedback
DEVICESham 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.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Items Correctly Named on the Philadelphia Naming Test | Baseline, 1 week following each intervention period | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Controlled Oral Word Association Test (COWA) Score | Baseline, 1 week following each intervention period | This is a measure of attention, executive function, and word-retrieval. COWA scores range from 0 to infinity. Lower scores represent more language impairment. |
| Change in Quality of Sleep as Assessed by the Pittsburgh Sleep Quality Index (PSQI) | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 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. |
| Change in Anxiety as Assessed by the State Trait Anxiety Inventory (STAI) | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | 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. |
| Change in Sleep Medication Dosage | Baseline, 1 week following each intervention period | Change in number of doses of sleep medication taken per week |
| Change in Sleep Medication Frequency | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods | Change in frequency of sleep medication taken per week. |
| Change in Absolute Power on EEG | Baseline, 1 week following each intervention period | Measurement of brainwave activity (absolute power in microvolts) in each frequency band (alpha, beta, theta, delta, gamma) on Quantitative EEG (qEEG). The difference in average absolute power is combined to report all frequency bands. |
| Change in Peak Amplitude Frequency on EEG | Baseline, 1 week following each intervention period | Measurement of brainwave activity (peak alpha amplitude frequency in hertz) on qEEG. |
| Change in EEG Absolute Power Z-scores | Baseline, 1 week following each intervention period | Comparison of z-scores for absolute power pre- and post-interventions. A Z-score of 0 represents the population mean. A z-score of \<-2 and \>2 is clinically worse than values approximating the z score central value (0) the population mean. |
| Change in EEG Peak Amplitude Frequency Z-scores | Baseline, 1 week following each intervention period | Comparison of z-scores for peak alpha amplitude frequency pre- and post-interventions. A z-score of \<-2 and \>2 is clinically worse than values approximating the z score central value (0) the population mean. |
| Change in EEG Coherence Z-scores | Baseline, 1 week following each intervention period | Comparison of z-scores for coherence between EEG sites in each of the frequency bands (alpha, beta, theta, delta, gamma). A Z-score of 0 represents the population mean. A z-score of \<-2 and \>2 is clinically worse than values approximating the z score central value (0) the population mean. The difference in average z-score is combined to report coherence in all frequency bands. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORArgye E Hillis, MD, MA
Johns Hopkins School of Medicine
Participant flow
Pre-assignment details
7 participants were enrolled. 1 participant withdrew before randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 22.6 |
| Controlled Oral Word Association (COWA) | 7.5 score on a scale STANDARD_DEVIATION 10.6 |
| Philadelphia Naming Test | 59 score on a scale STANDARD_DEVIATION 49.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
None listed