AphasiaCARTERNCT04290988
Circuitry Assessment and Reinforcement Training Effects on Recovery
A study testing EEG Neurofeedback in people with Aphasia and Primary Progressive Aphasia, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia, Primary Progressive Aphasia, Stroke
- What is being tested?
- EEG Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2020to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: Circuitry Assessment and Reinforcement Training Effects on Recovery (CARTER)
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.
Read the 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.
- Conditions
- Aphasia, Primary Progressive Aphasia, Stroke
- Being tested
- EEG Neurofeedback, Sham Feedback
- Keywords
- communication, language, speech, anxiety, sleep, neurofeedback
- Medical subject headings
- Aphasia, Aphasia, Primary Progressive, Stroke, Communication, Language, Speech, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EEG Neurofeedback |
| 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. Receives: Device: Sham Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 1 week following each intervention period
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, 1 week following each intervention period
Change in Sleep Medication Frequency
Change in frequency of sleep medication taken per week.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 week following each intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start23 Sep 2020
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Argye E Hillis, MD, MA, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290988
- Sponsor's protocol ID
- IRB00242136
- Acronym
- CARTER
- Status last verified
- Jan 2026
- First submitted
- 27 Feb 2020
- Last updated
- 5 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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/
PubMed 30299634Berube 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.
PubMed 30242341Collura, T. (2014). Technical foundations of neurofeedback. New York: Taylor and Francis.
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.
PubMed 12737092Hetkamp 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.
PubMed 30832518Nan 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.
PubMed 31396152Wang 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.
PubMed 31302517
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circuitry Assessment and Reinforcement Training Effects on Recovery (CARTER)
- ClinicalTrials.gov ID
- NCT04290988
- Acronym / sponsor ID
- CARTER / IRB00242136
- Conditions
- Aphasia, Primary Progressive Aphasia, Stroke
- Keywords
- communication, language, speech, anxiety, sleep, neurofeedback
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Posted 5 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active EEG Neurofeedback | Experimental | Device: EEG Neurofeedback15 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 | Device: Sham Feedback15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG NeurofeedbackActive EEG neurofeedback | Device | Active EEG Neurofeedback |
| Sham FeedbackSham 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. | Device | Sham Feedback |
Primary outcome
Change in Number of Items Correctly Named on the Philadelphia Naming Test
Time frame: 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)
10 secondary outcomes
Change in Controlled Oral Word Association Test (COWA) Score
Time frame: Baseline, 1 week following each intervention period
Change in Quality of Sleep as Assessed by the Pittsburgh Sleep Quality Index (PSQI)
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)
Time frame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Change in Sleep Medication Dosage
Time frame: Baseline, 1 week following each intervention period
Change in Sleep Medication Frequency
Time frame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Change in Absolute Power on EEG
Time frame: Baseline, 1 week following each intervention period
Change in Peak Amplitude Frequency on EEG
Time frame: Baseline, 1 week following each intervention period
Change in EEG Absolute Power Z-scores
Time frame: Baseline, 1 week following each intervention period
Change in EEG Peak Amplitude Frequency Z-scores
Time frame: Baseline, 1 week following each intervention period
Change in EEG Coherence Z-scores
Time frame: Baseline, 1 week following each intervention period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30299634Banerjee 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/
- Background: PubMed 30242341Berube 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.
- BackgroundCollura, T. (2014). Technical foundations of neurofeedback. New York: Taylor and Francis.
- Background: PubMed 12737092Fuchs 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.
- Background: PubMed 30832518Hetkamp 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.
- Background: PubMed 31396152Nan 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.
- Background: PubMed 31302517Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Argye E Hillis, MD, MA principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG Neurofeedback in people with Aphasia and Primary Progressive Aphasia, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of Items Correctly Named on the Philadelphia Naming Test (time frame: Baseline, 1 week following each intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04290988, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.