Clinical trial NCT04290988: Circuitry Assessment and Reinforcement Training Effects on Recovery
Official title: Circuitry Assessment and Reinforcement Training Effects on Recovery (CARTER)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Aphasia
Primary Progressive Aphasia
Stroke
Keywords: communication
language
speech
anxiety
sleep
neurofeedback
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Number of content units expressed in the Picture Description Test
timeFrame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Secondary outcomes:
measure: Change in number of items correctly named on the Philadelphia Naming Test
timeFrame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
measure: Change in Controlled Oral Word Association test (COWA) score
timeFrame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
measure: Change in quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
measure: Change in anxiety as assessed by the State Trait Anxiety Inventory (STAI)
timeFrame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
measure: Change in Sleep Medication Dose
timeFrame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
measure: Change in Sleep Medication Frequency
timeFrame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
measure: Change in absolute power on EEG
timeFrame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
measure: Change in peak amplitude frequency on EEG
timeFrame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
measure: Change in EEG absolute power z-scores
timeFrame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
measure: Change in EEG peak amplitude frequency z-scores
timeFrame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
measure: Change in EEG coherence z-scores
timeFrame: Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Argye E Hillis, MD, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/
citation: 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.
citation: Collura, T. (2014). Technical foundations of neurofeedback. New York: Taylor and Francis.
citation: 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.
citation: 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.
citation: 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.
citation: 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.