Circuitry Assessment and Reinforcement Training Effects on Recovery

NCT04290988 | Terminated Results FDA Device

• 1 other identifier: IRB00242136
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia; Primary Progressive Aphasia; Stroke

Keywords

communication; language; speech; anxiety; sleep; neurofeedback

Outcome Measures

Primary Outcomes (1)

• 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. The score range is 0 - 175 (higher scores reflect more accurate naming/better naming ability)

  Baseline, 1 week following each intervention period

Secondary Outcomes (10)

• Change in Controlled Oral Word Association Test (COWA) Score

  Baseline, 1 week following each intervention period

• 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 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 Sleep Medication Dosage

  Baseline, 1 week following each intervention period

• Change in Sleep Medication Frequency

  Baseline, 1 week following each intervention period and 8 weeks following both intervention periods

Study Arms (2)

Active EEG Neurofeedback

EXPERIMENTAL

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

Sham Feedback

SHAM COMPARATOR

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

Device: Sham Feedback

Interventions

EEG Neurofeedback DEVICE

Active EEG neurofeedback

Active EEG Neurofeedback

Sham Feedback DEVICE

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.

Sham Feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (7)

• 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/

  PMID: 30299634 BACKGROUND

• 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.

  PMID: 30242341 BACKGROUND

• Collura, T. (2014). Technical foundations of neurofeedback. New York: Taylor and Francis.

  BACKGROUND

• 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.

  PMID: 12737092 BACKGROUND

• 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.

  PMID: 30832518 BACKGROUND

• 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.

  PMID: 31396152 BACKGROUND

• 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.

  PMID: 31302517 BACKGROUND

MeSH Terms

Conditions

Aphasia; Aphasia, Primary Progressive; Stroke; Communication; Language; Speech; Anxiety Disorders

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Behavior; Verbal Behavior

Limitations and Caveats

This study was discontinued due to lack of funding before we could enroll our target number of participants and complete the study. Therefore, we couldn't complete the full analysis initially planned to determine the intervention's efficacy.

Results Point of Contact

• Title: Argye Hillis
• Organization: Johns Hopkins University

argye@jhmi.edu

410-955-9441

Study Officials

• Argye E Hillis, MD, MA

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: September 23, 2020
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 5, 2026
• Results First Posted: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)