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Circuitry Assessment and Reinforcement Training Effects on Recovery (CARTER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04290988
Recruitment Status : Not yet recruiting
First Posted : March 2, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Aphasia Primary Progressive Aphasia Stroke Device: EEG Neurofeedback Device: Sham Feedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Circuitry Assessment and Reinforcement Training Effects on Recovery (CARTER)
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : September 1, 2025


Arm Intervention/treatment
Experimental: Active EEG Neurofeedback
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
Active EEG neurofeedback

Sham Comparator: Sham Feedback
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
Device: Sham 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.




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


Secondary Outcome Measures :
  1. Change in number of items correctly named on the Philadelphia Naming Test [ Time Frame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods ]
    Change in number of items correctly named on a behavioral picture naming assessment.

  2. Change in Controlled Oral Word Association test (COWA) score [ Time Frame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods ]
    This is a measure of attention, executive function, and word-retrieval. COWA scores range from 0 to infinity. Lower scores represent more language impairment.

  3. 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 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.

  4. 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 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.

  5. Change in Sleep Medication Dose [ Time Frame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods ]
    Change in dose of sleep medication.

  6. Change in Sleep Medication Frequency [ Time Frame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods ]
    Change in frequency of sleep medication.

  7. Change in absolute power on EEG [ Time Frame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods ]
    Measurement of brainwave activity (absolute power in microvolts) in each frequency band (alpha, beta, theta, delta, gamma) on Quantitative EEG (qEEG).

  8. Change in peak amplitude frequency on EEG [ Time Frame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods ]
    Measurement of brainwave activity (peak amplitude frequency in hertz) in each frequency band (alpha, beta, theta, delta, gamma) on qEEG.

  9. Change in EEG absolute power z-scores [ Time Frame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods ]
    Comparison of z-scores for absolute power in each of the frequency bands (alpha, beta, theta, delta, gamma) pre- and post-interventions.

  10. Change in EEG peak amplitude frequency z-scores [ Time Frame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods ]
    Comparison of z-scores for peak amplitude frequency in each of the frequency bands (alpha, beta, theta, delta, gamma) pre- and post-interventions.

  11. Change in EEG coherence z-scores [ Time Frame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods ]
    Comparison of z-scores for coherence between EEG sites in each of the frequency bands (alpha, beta, theta, delta, gamma).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04290988


Contacts
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Contact: Argye E Hillis, MD, MA 443-287-4610 argye@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Contact: Argye Hillis, MD, MA    443-287-4610    argye@jhmi.edu   
Sub-Investigator: Rachel Mace, MS, CCC-SLP         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Argye E Hillis, MD, MA Johns Hopkins School of Medicine
Publications:
Banerjee S. & Argáez, C. (2017). Neurofeedback and biofeedback for mood and anxiety disorders: A review of clinical effectiveness and guidelines. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health. Available from: https://www.ncbi.nlm.nih.gov/books/NBK531603/
Collura, T. (2014). Technical foundations of neurofeedback. New York: Taylor and Francis.

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04290988    
Other Study ID Numbers: IRB00242136
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Johns Hopkins University:
communication
language
speech
anxiety
sleep
neurofeedback
Additional relevant MeSH terms:
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Aphasia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dementia
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases