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Circuitry Assessment and Reinforcement Training Effects on Recovery (CARTER)

Primary Purpose

Aphasia, Primary Progressive Aphasia, Stroke

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EEG Neurofeedback
Sham Feedback
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring communication, language, speech, anxiety, sleep, neurofeedback

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Johns Hopkins School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active EEG Neurofeedback

Sham Feedback

Arm Description

15 sessions of active EEG neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.

15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.

Outcomes

Primary Outcome Measures

Change in Number of content units expressed in the Picture Description Test
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
Change in number of items correctly named on a behavioral picture naming assessment.
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.
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.
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 anxiety.
Change in Sleep Medication Dose
Change in dose of sleep medication.
Change in Sleep Medication Frequency
Change in frequency of sleep medication.
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).
Change in peak amplitude frequency on EEG
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
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
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
Comparison of z-scores for coherence between EEG sites in each of the frequency bands (alpha, beta, theta, delta, gamma).

Full Information

First Posted
February 27, 2020
Last Updated
September 11, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04290988
Brief Title
Circuitry Assessment and Reinforcement Training Effects on Recovery
Acronym
CARTER
Official Title
Circuitry Assessment and Reinforcement Training Effects on Recovery (CARTER)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Suspended
Why Stopped
Lack of funding for the time being
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Primary Progressive Aphasia, Stroke
Keywords
communication, language, speech, anxiety, sleep, neurofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active EEG Neurofeedback
Arm Type
Experimental
Arm Description
15 sessions of active EEG neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
Arm Title
Sham Feedback
Arm Type
Sham Comparator
Arm Description
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
Intervention Type
Device
Intervention Name(s)
EEG Neurofeedback
Intervention Description
Active EEG neurofeedback
Intervention Type
Device
Intervention Name(s)
Sham Feedback
Intervention Description
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 Measure Information:
Title
Change in Number of content units expressed in the Picture Description Test
Description
Change in Number of content units expressed by the participant when describing what is seen in a picture.
Time Frame
Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Secondary Outcome Measure Information:
Title
Change in number of items correctly named on the Philadelphia Naming Test
Description
Change in number of items correctly named on a behavioral picture naming assessment.
Time Frame
Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Title
Change in Controlled Oral Word Association test (COWA) score
Description
This is a measure of attention, executive function, and word-retrieval. COWA scores range from 0 to infinity. Lower scores represent more language impairment.
Time Frame
Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Title
Change in quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Title
Change in anxiety as assessed by the State Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Title
Change in Sleep Medication Dose
Description
Change in dose of sleep medication.
Time Frame
Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Title
Change in Sleep Medication Frequency
Description
Change in frequency of sleep medication.
Time Frame
Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Title
Change in absolute power on EEG
Description
Measurement of brainwave activity (absolute power in microvolts) in each frequency band (alpha, beta, theta, delta, gamma) on Quantitative EEG (qEEG).
Time Frame
Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Title
Change in peak amplitude frequency on EEG
Description
Measurement of brainwave activity (peak amplitude frequency in hertz) in each frequency band (alpha, beta, theta, delta, gamma) on qEEG.
Time Frame
Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Title
Change in EEG absolute power z-scores
Description
Comparison of z-scores for absolute power in each of the frequency bands (alpha, beta, theta, delta, gamma) pre- and post-interventions.
Time Frame
Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Title
Change in EEG peak amplitude frequency z-scores
Description
Comparison of z-scores for peak amplitude frequency in each of the frequency bands (alpha, beta, theta, delta, gamma) pre- and post-interventions.
Time Frame
Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Title
Change in EEG coherence z-scores
Description
Comparison of z-scores for coherence between EEG sites in each of the frequency bands (alpha, beta, theta, delta, gamma).
Time Frame
Baseline, 1 week following each intervention period and 8 weeks following both intervention periods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Argye E Hillis, MD, MA
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30299634
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/
Results Reference
background
PubMed Identifier
30242341
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.
Results Reference
background
Citation
Collura, T. (2014). Technical foundations of neurofeedback. New York: Taylor and Francis.
Results Reference
background
PubMed Identifier
12737092
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.
Results Reference
background
PubMed Identifier
30832518
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.
Results Reference
background
PubMed Identifier
31396152
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.
Results Reference
background
PubMed Identifier
31302517
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.
Results Reference
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Circuitry Assessment and Reinforcement Training Effects on Recovery

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