CARTER: Circuitry Assessment and Reinforcement Training Effects on Recovery

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04290988

Collaborator

(none)

Enrollment

Location

Arms

59.3

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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.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)

Actual Study Start Date :

Sep 23, 2020

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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 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 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 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 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.
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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