fMRI Neurofeedback for Post-Stroke Reading Difficulties
(ReadingNFB Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kessler Foundation
Disqualifiers: Pregnancy, Brain tumor, Alzheimer's, others
No Placebo Group
Approved in 1 Jurisdiction
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.12345
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.23567
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.12468
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.
See 1 more
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.
Trial 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 (Behavioral Intervention)
- Sham fMRI Neurofeedback (Behavioral Intervention)
Trial OverviewThe 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
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
Kessler FoundationWest Orange, NJ
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Who Is Running the Clinical Trial?
Kessler FoundationLead Sponsor
References
The potential of real-time fMRI neurofeedback for stroke rehabilitation: A systematic review. [2019]Real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback aids the modulation of neural functions by training self-regulation of brain activity through operant conditioning. This technique has been applied to treat several neurodevelopmental and neuropsychiatric disorders, but its effectiveness for stroke rehabilitation has not been examined yet. Here, we systematically review the effectiveness of rt-fMRI neurofeedback training in modulating motor and cognitive processes that are often impaired after stroke. Based on predefined search criteria, we selected and examined 33 rt-fMRI neurofeedback studies, including 651 healthy individuals and 15 stroke patients in total. The results of our systematic review suggest that rt-fMRI neurofeedback training can lead to a learned modulation of brain signals, with associated changes at both the neural and the behavioural level. However, more research is needed to establish how its use can be optimized in the context of stroke rehabilitation.
Real-time functional magnetic resonance imaging neurofeedback in motor neurorehabilitation. [2022]Recent developments in functional magnetic resonance imaging (fMRI) have catalyzed a new field of translational neuroscience. Using fMRI to monitor the aspects of task-related changes in neural activation or brain connectivity, investigators can offer feedback of simple or complex neural signals/patterns back to the participant on a quasireal-time basis [real-time-fMRI-based neurofeedback (rt-fMRI-NF)]. Here, we introduce some background methodology of the new developments in this field and give a perspective on how they may be used in neurorehabilitation in the future.
Enhancing Motor Network Activity Using Real-Time Functional MRI Neurofeedback of Left Premotor Cortex. [2020]Neurofeedback by functional magnetic resonance imaging (fMRI) is a technique of potential therapeutic relevance that allows individuals to be aware of their own neurophysiological responses and to voluntarily modulate the activity of specific brain regions, such as the premotor cortex (PMC), important for motor recovery after brain injury. We investigated (i) whether healthy human volunteers are able to up-regulate the activity of the left PMC during a right hand finger tapping motor imagery (MI) task while receiving continuous fMRI-neurofeedback, and (ii) whether successful modulation of brain activity influenced non-targeted motor control regions. During the MI task, participants of the neurofeedback group (NFB) received ongoing visual feedback representing the level of fMRI responses within their left PMC. Control (CTL) group participants were shown similar visual stimuli, but these were non-contingent on brain activity. Both groups showed equivalent levels of behavioral ratings on arousal and MI, before and during the fMRI protocol. In the NFB, but not in CLT group, brain activation during the last run compared to the first run revealed increased activation in the left PMC. In addition, the NFB group showed increased activation in motor control regions extending beyond the left PMC target area, including the supplementary motor area, basal ganglia and cerebellum. Moreover, in the last run, the NFB group showed stronger activation in the left PMC/inferior frontal gyrus when compared to the CTL group. Our results indicate that modulation of PMC and associated motor control areas can be achieved during a single neurofeedback-fMRI session. These results contribute to a better understanding of the underlying mechanisms of MI-based neurofeedback training, with direct implications for rehabilitation strategies in severe brain disorders, such as stroke.
Advances in fMRI Real-Time Neurofeedback. [2018]Functional magnetic resonance imaging (fMRI) neurofeedback is a type of biofeedback in which real-time online fMRI signals are used to self-regulate brain function. Since its advent in 2003 significant progress has been made in fMRI neurofeedback techniques. Specifically, the use of implicit protocols, external rewards, multivariate analysis, and connectivity analysis has allowed neuroscientists to explore a possible causal involvement of modified brain activity in modified behavior. These techniques have also been integrated into groundbreaking new neurofeedback technologies, specifically decoded neurofeedback (DecNef) and functional connectivity-based neurofeedback (FCNef). By modulating neural activity and behavior, DecNef and FCNef have substantially advanced both basic and clinical research.
Graded fMRI Neurofeedback Training of Motor Imagery in Middle Cerebral Artery Stroke Patients: A Preregistered Proof-of-Concept Study. [2020]Ischemic stroke of the middle cerebral artery (MCA), a major brain vessel that supplies the primary motor and premotor cortex, is one of the most common causes for severe upper limb impairment. Currently available motor rehabilitation training largely lacks satisfying efficacy with over 70% of stroke survivors showing residual upper limb dysfunction. Motor imagery-based functional magnetic resonance imaging neurofeedback (fMRI-NF) has been suggested as a potential therapeutic technique to improve motor impairment in stroke survivors. In this preregistered proof-of-concept study (https://osf.io/y69jc/), we translated graded fMRI-NF training, a new paradigm that we have previously studied in healthy participants, to first-time MCA stroke survivors with residual mild to severe impairment of upper limb motor function. Neurofeedback was provided from the supplementary motor area (SMA) targeting two different neurofeedback target levels (low and high). We hypothesized that MCA stroke survivors will show (1) sustained SMA-region of interest (ROI) activation and (2) a difference in SMA-ROI activation between low and high neurofeedback conditions during graded fMRI-NF training. At the group level, we found only anecdotal evidence for these preregistered hypotheses. At the individual level, we found anecdotal to moderate evidence for the absence of the hypothesized graded effect for most subjects. These null findings are relevant for future attempts to employ fMRI-NF training in stroke survivors. The study introduces a Bayesian sequential sampling plan, which incorporates prior knowledge, yielding higher sensitivity. The sampling plan was preregistered together with a priori hypotheses and all planned analysis before data collection to address potential publication/researcher biases. Unforeseen difficulties in the translation of our paradigm to a clinical setting required some deviations from the preregistered protocol. We explicitly detail these changes, discuss the accompanied additional challenges that can arise in clinical neurofeedback studies, and formulate recommendations for how these can be addressed. Taken together, this work provides new insights about the feasibility of motor imagery-based graded fMRI-NF training in MCA stroke survivors and serves as a first example for comprehensive study preregistration of an (fMRI) neurofeedback experiment.
A Guide to Literature Informed Decisions in the Design of Real Time fMRI Neurofeedback Studies: A Systematic Review. [2020]Background: Although biofeedback using electrophysiology has been explored extensively, the approach of using neurofeedback corresponding to hemodynamic response is a relatively young field. Real time functional magnetic resonance imaging-based neurofeedback (rt-fMRI-NF) uses sensory feedback to operantly reinforce patterns of neural response. It can be used, for example, to alter visual perception, increase brain connectivity, and reduce depression symptoms. Within recent years, interest in rt-fMRI-NF in both research and clinical contexts has expanded considerably. As such, building a consensus regarding best practices is of great value. Objective: This systematic review is designed to describe and evaluate the variations in methodology used in previous rt-fMRI-NF studies to provide recommendations for rt-fMRI-NF study designs that are mostly likely to elicit reproducible and consistent effects of neurofeedback. Methods: We conducted a database search for fMRI neurofeedback papers published prior to September 26th, 2019. Of 558 studies identified, 146 met criteria for inclusion. The following information was collected from each study: sample size and type, task used, neurofeedback calculation, regulation procedure, feedback, whether feedback was explicitly related to changing brain activity, feedback timing, control group for active neurofeedback, how many runs and sessions of neurofeedback, if a follow-up was conducted, and the results of neurofeedback training. Results: rt-fMRI-NF is typically upregulation practice based on hemodynamic response from a specific region of the brain presented using a continually updating thermometer display. Most rt-fMRI-NF studies are conducted in healthy samples and half evaluate its effect on immediate changes in behavior or affect. The most popular control group method is to provide sham signal from another region; however, many studies do not compare use a comparison group. Conclusions: We make several suggestions for designs of future rt-fMRI-NF studies. Researchers should use feedback calculation methods that consider neural response across regions (i.e., SVM or connectivity), which should be conveyed as intermittent, auditory feedback. Participants should be given explicit instructions and should be assessed on individual differences. Future rt-fMRI-NF studies should use clinical samples; effectiveness of rt-fMRI-NF should be evaluated on clinical/behavioral outcomes at follow-up time points in comparison to both a sham and no feedback control group.
Quality and denoising in real-time functional magnetic resonance imaging neurofeedback: A methods review. [2021]Neurofeedback training using real-time functional magnetic resonance imaging (rtfMRI-NF) allows subjects voluntary control of localised and distributed brain activity. It has sparked increased interest as a promising non-invasive treatment option in neuropsychiatric and neurocognitive disorders, although its efficacy and clinical significance are yet to be determined. In this work, we present the first extensive review of acquisition, processing and quality control methods available to improve the quality of the neurofeedback signal. Furthermore, we investigate the state of denoising and quality control practices in 128 recently published rtfMRI-NF studies. We found: (a) that less than a third of the studies reported implementing standard real-time fMRI denoising steps, (b) significant room for improvement with regards to methods reporting and (c) the need for methodological studies quantifying and comparing the contribution of denoising steps to the neurofeedback signal quality. Advances in rtfMRI-NF research depend on reproducibility of methods and results. Notably, a systematic effort is needed to build up evidence that disentangles the various mechanisms influencing neurofeedback effects. To this end, we recommend that future rtfMRI-NF studies: (a) report implementation of a set of standard real-time fMRI denoising steps according to a proposed COBIDAS-style checklist (https://osf.io/kjwhf/), (b) ensure the quality of the neurofeedback signal by calculating and reporting community-informed quality metrics and applying offline control checks and (c) strive to adopt transparent principles in the form of methods and data sharing and support of open-source rtfMRI-NF software. Code and data for reproducibility, as well as an interactive environment to explore the study data, can be accessed at https://github.com/jsheunis/quality-and-denoising-in-rtfmri-nf.
Functional magnetic resonance imaging (FMRI) neurofeedback: implementations and applications. [2022]Neurofeedback (NFB) allows subjects to learn how to volitionally influence the neuronal activation in the brain by employing real-time neural activity as feedback. NFB has already been performed with electroencephalography (EEG) since the 1970s. Functional MRI (fMRI), offering a higher spatial resolution, has further increased the spatial specificity. In this paper, we briefly outline the general principles behind NFB, the implementation of fMRI-NFB studies, the feasibility of fMRI-NFB, and the application of NFB as a supplementary therapy tool.