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

Trial Summary

What is the purpose of this trial?

The overall goal of this project is to advance a biologically-based approach to treatment of reading disorders after stroke, which will expand the limits of cognitive rehabilitation. Using a novel brain imaging technique, called real-time functional magnetic resonance imaging (fMRI) neurofeedback combined with right hand motor imagery, this project will re-instate brain activity in the left language-dominant hemisphere. Stroke patients will practice modulating their own brain activity using fMRI neurofeedback signal and will select the most effective mental strategies that help them maintain brain activation patterns associated with better reading recovery.

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 data supports the effectiveness of the treatment Real-Time 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 stroke. While more studies are needed specifically for stroke rehabilitation, this technique has shown promise in enhancing brain activity related to motor control, which could be beneficial for recovery. ^{1 2 3 4 5}

Is fMRI neurofeedback safe for humans?

fMRI neurofeedback is generally considered safe for humans, as it is a non-invasive technique that has been used in various studies, including those involving healthy participants and stroke survivors. However, the effectiveness and clinical significance of this treatment are still being researched. ^{2 3 5 6 7}

How is the treatment Real-Time fMRI Neurofeedback different from other treatments for post-stroke reading difficulties?

Real-Time fMRI Neurofeedback is unique because it uses real-time brain imaging to help patients learn to control their brain activity, potentially improving cognitive functions like reading. Unlike traditional therapies, it provides immediate feedback on brain activity, allowing patients to self-regulate and potentially enhance recovery. ^{1 2 4 6 8}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

The potential of real-time fMRI neurofeedback for stroke rehabilitation: A systematic review. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Real-time functional magnetic resonance imaging neurofeedback in motor neurorehabilitation. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Enhancing Motor Network Activity Using Real-Time Functional MRI Neurofeedback of Left Premotor Cortex. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Advances in fMRI Real-Time Neurofeedback. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Graded fMRI Neurofeedback Training of Motor Imagery in Middle Cerebral Artery Stroke Patients: A Preregistered Proof-of-Concept Study. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Guide to Literature Informed Decisions in the Design of Real Time fMRI Neurofeedback Studies: A Systematic Review. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Quality and denoising in real-time functional magnetic resonance imaging neurofeedback: A methods review. [2021]

8. Malaysia pubmed.ncbi.nlm.nih.gov

Functional magnetic resonance imaging (FMRI) neurofeedback: implementations and applications. [2022]