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Behavioral Intervention

fMRI Neurofeedback for Post-Stroke Reading Difficulties (ReadingNFB Trial)

N/A
Recruiting
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: 18 - 80 years old
Be older than 18 years old
Must not have
A history of prior neurological disease (e.g., brain tumor, Alzheimer's disease)
Inability to consent or complete study tasks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at intervention week 1, 2, and 3

Summary

This trial will use fMRI neurofeedback to help stroke patients re-activate the left language-dominant hemisphere of the brain for better reading recovery.

Who is the study for?
This trial is for individuals aged 18-80 who have had their first-ever stroke affecting the left hemisphere within the last 10 weeks, or are healthy volunteers. Participants must have been fluent in English and literate before the stroke and now show reading deficits as confirmed by a specific test (RCBA-2). Those with MRI contraindications or previous neurological diseases cannot join.
What is being tested?
The study tests a new treatment approach for post-stroke reading disorders using real-time fMRI neurofeedback with motor imagery. Patients will learn to control brain activity in language areas through feedback from brain scans, aiming to improve reading recovery.
What are the potential side effects?
Since this intervention involves non-invasive brain imaging and mental exercises, there are minimal physical side effects expected. However, participants may experience fatigue or discomfort from lying still during MRI scanning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a brain-related illness before.
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I am unable to give consent or complete study tasks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at intervention week 1, 2, and 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at intervention week 1, 2, and 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reading Aloud Accuracy
fMRI Brain Activity
Secondary study objectives
Boston Naming Test (BNT-short)
Geriatric Depression Scale (GDS)
Neuro evaluation
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Motor Imagery and Contingent Neurofeedback (NFB)Experimental Treatment1 Intervention
This group will receive real-time fMRI NFB on the bases of participant's own brain activity
Group II: Motor Imagery and Non-contingent Neurofeedback (NFB)Placebo Group1 Intervention
This group will receive group will receive fMRI NFB based on another participant's brain activity

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor
184 Previous Clinical Trials
11,241 Total Patients Enrolled
28 Trials studying Stroke
2,560 Patients Enrolled for Stroke

Media Library

Real-Time fMRI Neurofeedback (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04875936 — N/A
Stroke Research Study Groups: Motor Imagery and Contingent Neurofeedback (NFB), Motor Imagery and Non-contingent Neurofeedback (NFB)
Stroke Clinical Trial 2023: Real-Time fMRI Neurofeedback Highlights & Side Effects. Trial Name: NCT04875936 — N/A
Real-Time fMRI Neurofeedback (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04875936 — N/A
~13 spots leftby Jun 2026
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