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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at intervention week 1, 2, and 3

Awards & highlights

ReadingNFB Trial 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.Check my eligibility

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.See study design

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.

ReadingNFB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 80 years old.

ReadingNFB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at intervention week 1, 2, and 3

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reading Aloud Accuracy

fMRI Brain Activity

Secondary outcome measures

Boston Naming Test (BNT-short)

Geriatric Depression Scale (GDS)

Neuro evaluation

+3 more

ReadingNFB 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor

174 Previous Clinical Trials

10,710 Total Patients Enrolled

26 Trials studying Stroke

2,445 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any slots available for enrolment in this clinical experiment?

"As attested by the clinicaltrials.gov website, this trial is open for enrolment as of October 21st 2022 and was originally posted on November 1st 2022."

Answered by AI

How many subjects are participating in this trial?

"Affirmative. According to clinicaltrials.gov, the recruitment process of this experiment is currently underway; it commenced on November 1st 2022 and was last updated October 21st 2022. 28 participants are being sought from a solitary site for enrolment in the trial."

Answered by AI

What outcomes is this medical trial trying to produce?

"The primary metric of this trial, evaluated at intervention weeks 1, 2 and 3 is the Reading Aloud Accuracy. Secondary outcomes encompass the Boston Naming Test (BNT-short), which evaluates word finding ability with scores ranging from 0 to 15; The Reading Comprehension Battery for Aphasia (RCBA-2) that assesses reading comprehension skills with a score range of 0 - 100; And the Palm Trees and Pyramids test touching upon semantics, phonology, and orthography through 60 items per subtask."

Answered by AI

Does this clinical trial restrict participation to adults only?

"This medical trial has an age cutoff between 18 and 80 years old. Those younger than the former can find 52 other trials, while those older than the latter have access to 1005 more options."

Answered by AI

Am I eligible to participate in this scientific experiment?

"The trial is actively recruiting twenty-eight individuals aged between eighteen and eighty, who have recently had a stroke. In order to be considered eligible for the study, these patients must display reading deficits in accordance with RCBA-2nd ed., have suffered from their first left-hemisphere stroke within 5 weeks of recruitment, speak English fluently prior to the event, and meet all other criteria requested by the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neurofeedback Intervention for Reading Deficits in Subacute Stroke

Olga Boukrina 2023. "Neurofeedback Intervention for Reading Deficits in Subacute Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04875936.

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