Circuitry Assessment and Reinforcement Training Effects on Recovery

Not Applicable

Suspended

• Conditions: Aphasia; Primary Progressive Aphasia; Stroke
• Interventions: Device: Sham Feedback; Device: EEG Neurofeedback

• Registration Number: NCT04290988
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-02
• Study Start: 2020-09-23
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Feedback	Sham Feedback	15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
Active EEG Neurofeedback	EEG Neurofeedback	15 sessions of active EEG neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Number of content units expressed in the Picture Description Test	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

Name	Time	Method
Change in number of items correctly named on the Philadelphia Naming Test	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.
Change in Controlled Oral Word Association test (COWA) score	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.
Change in Sleep Medication Dose	Baseline, 1 week following each intervention period and 8 weeks following both intervention periods	Change in dose of sleep medication.
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.
Change in absolute power on EEG	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).
Change in peak amplitude frequency on EEG	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.
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 anxiety.
Change in EEG absolute power z-scores	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.
Change in EEG coherence z-scores	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).
Change in EEG peak amplitude frequency z-scores	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.

Trial Locations

Locations (1)

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States