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Lack of funding
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active EEG Neurofeedback | Experimental | 15 sessions of active EEG neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks. |
|
| Sham Feedback | Sham Comparator | 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG Neurofeedback | Device | Active EEG neurofeedback |
| |
| 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. The score range is 0 - 175 (higher scores reflect more accurate naming/better naming ability) | Baseline, 1 week following each intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Quality of Sleep as Assessed by the Pittsburgh Sleep Quality Index (PSQI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Argye E Hillis, MD, MA | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30299634 | Background | Banerjee S, Argaez C. Neurofeedback and Biofeedback for Mood and Anxiety Disorders: A Review of Clinical Effectiveness and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2017 Nov 13. Available from http://www.ncbi.nlm.nih.gov/books/NBK531603/ | |
| 30242341 | Background |
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7 participants were enrolled. 1 participant withdrew before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active EEG Neurofeedback, Then Sham Neurofeedback | 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks. |
| FG001 | Sham Feedback, Then Active Neurofeedback | 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active EEG Neurofeedback, Then Sham Neurofeedback | 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks. |
| BG001 | Sham Feedback, Then Active Neurofeedback |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | Number of Items Correct on Naming Test | Baseline, 1 week following each intervention period |
|
enrollment until end of follow up, approximately 5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active EEG Neurofeedback | 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks . |
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This study was discontinued due to lack of funding before we could enroll our target number of participants and complete the study. Therefore, we couldn't complete the full analysis initially planned to determine the intervention's efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Argye Hillis | Johns Hopkins University | 410-955-9441 | argye@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2021 | Oct 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D018888 | Aphasia, Primary Progressive |
| D020521 | Stroke |
| D003142 | Communication |
| D007802 | Language |
| D013060 | Speech |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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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.
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| Sham Feedback |
| 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. |
|
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 (worse) anxiety. STAI Part 1 Score range 20-80 and STAI Part 2 score range 20-80 with higher scores representing greater (worse) anxiety. | 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 | Baseline, 1 week following each intervention period |
| Change in Sleep Medication Frequency | Change in frequency of sleep medication taken per week. | 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). The difference in average absolute power is combined to report all frequency bands. | Baseline, 1 week following each intervention period |
| Change in Peak Amplitude Frequency on EEG | Measurement of brainwave activity (peak alpha amplitude frequency in hertz) on qEEG. | Baseline, 1 week following each intervention period |
| Change in EEG Absolute Power Z-scores | 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. | Baseline, 1 week following each intervention period |
| Change in EEG Peak Amplitude Frequency Z-scores | 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. | Baseline, 1 week following each intervention period |
| 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). 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. | Baseline, 1 week following each intervention period |
| Berube S, Nonnemacher J, Demsky C, Glenn S, Saxena S, Wright A, Tippett DC, Hillis AE. Stealing Cookies in the Twenty-First Century: Measures of Spoken Narrative in Healthy Versus Speakers With Aphasia. Am J Speech Lang Pathol. 2019 Mar 11;28(1S):321-329. doi: 10.1044/2018_AJSLP-17-0131. |
| Background | Collura, T. (2014). Technical foundations of neurofeedback. New York: Taylor and Francis. |
| 12737092 | Background | Fuchs T, Birbaumer N, Lutzenberger W, Gruzelier JH, Kaiser J. Neurofeedback treatment for attention-deficit/hyperactivity disorder in children: a comparison with methylphenidate. Appl Psychophysiol Biofeedback. 2003 Mar;28(1):1-12. doi: 10.1023/a:1022353731579. |
| 30832518 | Background | Hetkamp M, Bender J, Rheindorf N, Kowalski A, Lindner M, Knispel S, Beckmann M, Tagay S, Teufel M. A Systematic Review of the Effect of Neurofeedback in Cancer Patients. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419832361. doi: 10.1177/1534735419832361. |
| 31396152 | Background | Nan W, Dias APB, Rosa AC. Neurofeedback Training for Cognitive and Motor Function Rehabilitation in Chronic Stroke: Two Case Reports. Front Neurol. 2019 Jul 24;10:800. doi: 10.3389/fneur.2019.00800. eCollection 2019. |
| 31302517 | Background | Wang SY, Lin IM, Fan SY, Tsai YC, Yen CF, Yeh YC, Huang MF, Lee Y, Chiu NM, Hung CF, Wang PW, Liu TL, Lin HC. The effects of alpha asymmetry and high-beta down-training neurofeedback for patients with the major depressive disorder and anxiety symptoms. J Affect Disord. 2019 Oct 1;257:287-296. doi: 10.1016/j.jad.2019.07.026. Epub 2019 Jul 5. |
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Philadelphia Naming Test | The score range is 0 - 175 (higher scores reflect more accurate naming/better naming ability | Mean | Standard Deviation | score on a scale |
|
| Controlled Oral Word Association (COWA) | Score ranges from 0 to the total number of correct words that begin with one of the letters in the set. There is no ceiling of a maximum score. Higher numbers reflect better verbal fluency. | Mean | Standard Deviation | score on a scale |
|
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Number of Correct Items on COWA Test | Baseline, 1 week following each intervention period |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Score on Pittsburgh Sleep Quality Index | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods |
|
|
|
| Secondary | 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. | Participants with data collected. One participant in each group was unable to complete this self-reported index due to the severity of their language deficits related to their aphasia prohibiting them from completing the questionnaire items. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods |
|
|
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| Secondary | Change in Sleep Medication Dosage | Change in number of doses of sleep medication taken per week | Posted | Mean | Standard Deviation | mg | Baseline, 1 week following each intervention period |
|
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| Secondary | Change in Sleep Medication Frequency | Change in frequency of sleep medication taken per week. | Posted | Mean | Standard Deviation | Number of Doses taken per week | Baseline, 1 week following each intervention period and 8 weeks following both intervention periods |
|
|
|
| Secondary | 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). The difference in average absolute power is combined to report all frequency bands. | Posted | Mean | Standard Deviation | EEG Absolute Power (microvolts) | Baseline, 1 week following each intervention period |
|
|
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| Secondary | Change in Peak Amplitude Frequency on EEG | Measurement of brainwave activity (peak alpha amplitude frequency in hertz) on qEEG. | Posted | Mean | Standard Deviation | Peak amplitude frequency (Hz) | Baseline, 1 week following each intervention period |
|
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|
| Secondary | Change in EEG Absolute Power Z-scores | 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. | Posted | Mean | Standard Deviation | z score | Baseline, 1 week following each intervention period |
|
|
|
| Secondary | Change in EEG Peak Amplitude Frequency Z-scores | 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. | Posted | Mean | Standard Deviation | z score | Baseline, 1 week following each intervention period |
|
|
|
| Secondary | 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). 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. | Posted | Mean | Standard Deviation | z-score | Baseline, 1 week following each intervention period |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Sham Feedback | 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks | 0 | 6 | 0 | 6 | 0 | 6 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D014705 | Verbal Behavior |
| Difference Post Phase 1, STAI Part 2 |
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| Difference Post Phase 2, STAI Part 2 |
|