fMRI Neurofeedback for Post-Stroke Reading Difficulties

(ReadingNFB Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Pregnancy, Brain tumor, Alzheimer's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals who have difficulty reading due to a recent stroke. It employs a special brain imaging technique called real-time fMRI neurofeedback, enabling participants to learn how to control their brain activity to enhance reading skills. The trial includes two groups: one receives feedback based on personal brain activity, while the other receives feedback from another participant’s brain activity. Volunteers should have experienced their first left-side stroke within the last three months and currently face reading difficulties. As an unphased trial, it offers a unique opportunity to contribute to innovative research and potentially improve reading skills.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this fMRI neurofeedback technique is safe for post-stroke reading difficulties?

Research has shown that real-time fMRI neurofeedback, a method that helps people control their brain activity, is generally well-tolerated. One study found that this technique helped stroke patients improve their brain signals without causing major side effects. Participants learned to change their brain patterns to aid recovery, and no serious adverse events occurred. Another study mentioned that this method is being tested for safety and has shown promising results so far. Overall, evidence suggests that fMRI neurofeedback is safe, with participants experiencing few, if any, side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using real-time fMRI neurofeedback to address post-stroke reading difficulties because it offers a novel approach by directly engaging and retraining the brain's activity. Unlike traditional speech therapy or medication, this method uses real-time brain imaging to provide feedback based on the participant's own brain activity, potentially speeding up recovery and improving outcomes. Additionally, the sham comparator arm, which uses feedback from another participant's brain activity, allows researchers to assess the true impact of personalized neurofeedback, offering insights into how tailored interventions might enhance rehabilitation for stroke survivors.

What evidence suggests that real-time fMRI neurofeedback is effective for post-stroke reading difficulties?

Research has shown that real-time fMRI neurofeedback, which participants in this trial may receive, can help individuals learn to control their brain activity, potentially enhancing movement and cognitive skills after a stroke. In earlier studies, stroke participants demonstrated significant improvements in reading and speech-related skills. This technique uses brain imaging to provide feedback, enabling patients to practice altering their brain activity patterns. The goal is to reactivate brain areas essential for better reading recovery. Early results are promising, suggesting that repeated practice with this method can help stroke patients improve their reading abilities. Meanwhile, another group in this trial will receive sham fMRI neurofeedback, serving as a control to evaluate the effectiveness of the real-time fMRI neurofeedback. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Fluent and literate in English prior to stroke

I had my first stroke in the left side of my brain less than 10 weeks ago, or I am a healthy volunteer.

You have trouble reading and understanding written paragraphs.

Exclusion Criteria

I have had a brain-related illness before.

Inability to undergo MRI (e.g., pregnancy, non-MRI compatible implants, claustrophobia)

I am unable to give consent or complete study tasks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive real-time fMRI neurofeedback combined with right hand motor imagery to modulate brain activity for reading recovery

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Real-Time fMRI Neurofeedback
• Sham fMRI Neurofeedback

Trial Overview 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.

How Is the Trial Designed?

Group I: Motor Imagery and Contingent Neurofeedback (NFB) Experimental Treatment 1 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 Group 1 Intervention

This group will receive group will receive fMRI NFB based on another participant's brain activity

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

Real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback training shows promise in helping individuals learn to modulate their brain activity, which could be beneficial for stroke rehabilitation, as indicated by a review of 33 studies involving 651 healthy individuals and 15 stroke patients.

The training resulted in observable changes in both brain signals and behavior, suggesting its potential effectiveness, but further research is necessary to optimize its application specifically for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential of real-time fMRI neurofeedback for stroke rehabilitation: A systematic review. Wang, T., Mantini, D., Gillebert, CR.[2019]

Healthy volunteers can successfully increase activity in the left premotor cortex (PMC) during a motor imagery task using fMRI neurofeedback, indicating the potential for self-regulation of brain activity.

The neurofeedback group not only enhanced PMC activity but also showed increased activation in other motor control regions, suggesting that this technique could be beneficial for rehabilitation in conditions like stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Motor Network Activity Using Real-Time Functional MRI Neurofeedback of Left Premotor Cortex. Marins, TF., Rodrigues, EC., Engel, A., et al.[2020]

Real-time fMRI-based neurofeedback (rt-fMRI-NF) allows participants to self-regulate brain activity, showing promise for neurorehabilitation by targeting specific brain regions, including subcortical areas.

In conditions like Parkinson's disease and stroke, rt-fMRI-NF has been shown to change neural activity and influence behaviors after training, indicating its potential to promote neuroplasticity, although more rigorous clinical trials are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time functional magnetic resonance imaging neurofeedback in motor neurorehabilitation. Linden, DE., Turner, DL.[2022]

This study explored the use of motor imagery-based fMRI neurofeedback (fMRI-NF) to improve upper limb function in first-time MCA stroke survivors, but found only anecdotal evidence supporting the effectiveness of this approach.

Despite the lack of significant group-level results, the study highlights the importance of preregistration and a Bayesian sampling plan in clinical research, providing insights into the challenges of implementing neurofeedback training in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graded fMRI Neurofeedback Training of Motor Imagery in Middle Cerebral Artery Stroke Patients: A Preregistered Proof-of-Concept Study. Mehler, DMA., Williams, AN., Whittaker, JR., et al.[2020]

Neurofeedback (NFB) enables individuals to consciously control their brain activity by using real-time feedback from their neural activity, which has been traditionally done with EEG and is now enhanced by fMRI for better spatial resolution.

fMRI-NFB is feasible and can serve as a supplementary therapy tool, potentially improving treatment outcomes by allowing for more precise targeting of brain regions involved in various conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional magnetic resonance imaging (FMRI) neurofeedback: implementations and applications. Dewiputri, WI., Auer, T.[2022]

fMRI neurofeedback allows individuals to self-regulate their brain function using real-time brain activity signals, which has evolved significantly since its introduction in 2003.

New techniques like decoded neurofeedback (DecNef) and functional connectivity-based neurofeedback (FCNef) have enhanced our understanding of how changes in brain activity can influence behavior, advancing both research and potential clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in fMRI Real-Time Neurofeedback. Watanabe, T., Sasaki, Y., Shibata, K., et al.[2018]

Real-time functional magnetic resonance imaging-based neurofeedback (rt-fMRI-NF) shows promise in altering brain activity and reducing symptoms of depression, but most studies have focused on healthy participants rather than clinical populations.

The review suggests that future rt-fMRI-NF studies should incorporate better feedback methods, use clinical samples, and include appropriate control groups to enhance the reproducibility and effectiveness of neurofeedback interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Guide to Literature Informed Decisions in the Design of Real Time fMRI Neurofeedback Studies: A Systematic Review. Fede, SJ., Dean, SF., Manuweera, T., et al.[2020]

Neurofeedback training using real-time fMRI (rtfMRI-NF) shows promise as a non-invasive treatment for neuropsychiatric disorders, but its efficacy and clinical significance are still under investigation, as highlighted by a review of 128 studies.

The review revealed that less than one-third of studies implemented standard denoising methods, indicating a need for improved reporting and quality control practices to enhance the reliability of neurofeedback signals in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and denoising in real-time functional magnetic resonance imaging neurofeedback: A methods review. Heunis, S., Lamerichs, R., Zinger, S., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39802782/

Feasibility of real-time fMRI neurofeedback for rehabilitation of ... Results: Preliminary findings demonstrate that stroke participants showed significant improvements in reading comprehension and phonological ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04875936

Neurofeedback Intervention for Reading Deficits in ... Stroke patients will practice modulating their own brain activity using fMRI neurofeedback signal and will select the most effective mental strategies that help ...

3. withpower.com withpower.com/trial/phase-dyslexia-9-2021-431e9

fMRI Neurofeedback for Post-Stroke Reading Difficulties Research suggests that real-time fMRI neurofeedback can help people learn to control brain activity, which may improve motor and cognitive functions after a ...

4. researchgate.net researchgate.net/publication/387749306_Feasibility_of_real-time_fMRI_neurofeedback_for_rehabilitation_of_reading_deficits_in_aphasia

(PDF) Feasibility of real-time fMRI neurofeedback for ... Repeated self-regulation efforts can drive learning-induced cognitive and motor improvements5. 66. Two studies have explored fMRI NFB for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6182108/

The potential of real-time fMRI neurofeedback for stroke ... The results of our systematic review suggest that rt-fMRI neurofeedback training can lead to a learned modulation of brain signals, with associated changes.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1877065721000798

Real-time fMRI and EEG neurofeedback: A perspective on ... We describe a new rehabilitation technique for spatial neglect that directly targets brain activity and pathological physiological processes.