MI-Based Training for Stroke Survivors

Overseen By Rinku Roy, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: North Carolina State University

Disqualifiers: Severe pain, Rigid contractures, Cognitive deficits, others

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

Compensation: Varies

Number of Visits: 10

Duration: 3-5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy for stroke survivors who have difficulty using their hands. It compares two treatments: one uses mental practice to change brain patterns and improve hand function (known as neurofeedback-based therapy), while the other involves traditional hand exercises. The goal is to determine if the mental practice method can enhance all stages of grasping (opening, closing, and releasing) more effectively than standard exercises. Ideal participants are adults who had a stroke at least six months ago and still struggle with tasks like opening and grasping objects. As an unphased trial, this study allows participants to contribute to innovative research that could improve rehabilitation methods for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this neurofeedback-based therapy is safe for stroke survivors?

Research has shown that neurofeedback therapy is generally safe for stroke survivors. Studies indicate that this therapy can improve arm and hand movement and enhance daily life quality for stroke patients. A review found that neurofeedback training can alter brain signals without causing harm. Another study found it safe to conduct neurofeedback therapy at home for individuals with chronic pain, demonstrating it is well-tolerated.

While these findings suggest that neurofeedback therapy usually does not cause side effects, individual reactions may vary. Discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about neurofeedback-based therapy for stroke survivors because it offers a novel approach to rehabilitation by training participants to modulate their own brain activation patterns using Mental Imagery (MI). This technique uses real-time visual feedback to help participants achieve specific changes in brain responses, which is a departure from traditional therapies that often focus on repetitive physical exercises. Additionally, the integration of an EMG-controlled hand exoskeleton to assist in hand movements provides a unique mechanical aid to support recovery, potentially enhancing motor function more effectively than conventional hand exercises alone. This innovative combination of neurofeedback and technology could pave the way for more personalized and efficient stroke rehabilitation strategies.

What evidence suggests that this trial's treatments could be effective for stroke survivors?

Research has shown that neurofeedback therapy, which participants in this trial may receive, can help stroke survivors improve arm and hand movements. This therapy alters brain activity patterns through mental imagery, similar to imagining performing a task. These changes can facilitate opening, closing, and releasing objects with the hands. Evidence suggests that neurofeedback training strengthens brain signals related to movement, enhancing control of hand tasks. Specifically, previous patients demonstrated improvements in hand function after learning to manage their brain activity with this therapy. This approach offers hope for enhancing the daily lives of stroke survivors. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults who have had a stroke and are struggling with hand movements. Participants will be trained to use their thoughts to control hand tasks like opening, closing, and releasing objects using an EEG-based method.

Inclusion Criteria

I have hand disability in one hand due to a stroke.

Ability to distinguish specific shapes and colors on a computer screen

I have trouble opening my hand and holding things.

Exclusion Criteria

Inability to provide informed consent

I have a neurological condition that is not a stroke.

I have severe difficulty with understanding language or noticing things on one side.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 10 sessions of either neurofeedback-based therapy or standard hand exercises over 3-5 weeks

3-5 weeks

10 sessions (2-3 sessions per week)

Follow-up

Participants are monitored for changes in hand function using standardized tests

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neurofeedback - based therapy

Trial Overview The study tests if controlling brain patterns through neurofeedback can improve hand function in stroke survivors. It compares this new therapy against standard exercises by measuring the ability to grasp after training sessions.

How Is the Trial Designed?

Group I: Neurofeedback - based therapy group Experimental Treatment 1 Intervention

In this arm/group, each participant will undergo a series of ten sessions (2-3 sessions per week) over a period of 3-5 weeks. Participants will be trained in modulating their brain activation patterns by using Mental Imagery (MI) involving various hand movements. EEG will be used to record brain responses. A visual feedback will be provided during the training to help achieve specific changes in brain responses. Once an appropriate brain response is achieved, an EMG-controlled hand exoskeleton will aid in opening and closing the hand.

Group II: Standard Hand exercises therapy group Active Control 1 Intervention

In this arm/group, each participant will undergo a series of ten sessions (2-3 sessions per week) over a period of 3-5 weeks. At each session, participants will practice a particular set of hand exercises. In this intervention, a variety of games, tasks, and movements will be used to improve grasping abilities. These exercises will be personalized according to each participant's interests, which will be identified through the Canadian Occupational Performance Measure and will be guided by study personnel.

Who Is Running the Clinical Trial?

North Carolina State University

Lead Sponsor

Trials

38

Recruited

50,000+

Published Research Related to This Trial

Neurofeedback therapy (NFT) shows promise in improving cognitive deficits in stroke patients, with most of the eight studies reviewed reporting positive outcomes after therapy initiation.

However, the overall quality of the studies was limited, which affects the reliability of the findings, highlighting the need for better-designed research and standardized NFT protocols to fully understand its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback as a form of cognitive rehabilitation therapy following stroke: A systematic review. Renton, T., Tibbles, A., Topolovec-Vranic, J.[2022]

A comprehensive neurorehabilitation program using biofeedback significantly improved support responses in 59 post-stroke patients compared to standard therapy, indicating its efficacy in rehabilitation.

Patients in the biofeedback group experienced increased strength, reduced spasticity in the affected arm, and improvements in anxiety, depression, and cognitive functions, showcasing the program's holistic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficiency of a comprehensive program with biological feedback on support reaction in the restoring period of stroke]. Kotov, SV., Egorova, YV., Isakova, EV.[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]

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]

Neurofeedback (NFB) shows promise as a complementary therapy for motor rehabilitation in chronic stroke patients, potentially enhancing traditional rehabilitation methods by adapting to individual patient needs based on brain imaging and clinical context.

The review emphasizes the importance of integrating engineering advancements with medical expertise to improve NFB technologies, aiming to better understand brain recovery mechanisms and promote cerebral plasticity after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward an Adapted Neurofeedback for Post-stroke Motor Rehabilitation: State of the Art and Perspectives. Le Franc, S., Herrera Altamira, G., Guillen, M., et al.[2022]

Citations

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6668042/

Neurofeedback Training for Cognitive and Motor Function ... Our results suggested that with the help of NFT, the chronic stroke patients were able to enhance their alpha activity, and achieve improvement ...

3. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2023.1155584/full

Neurofeedback therapy to improve cognitive function in ... We investigated a slow-cortical potential (SCP) neurofeedback therapy approach for rehabilitating chronic attention deficits after stroke.

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Specific effects of EEG based neurofeedback training on ... Post-stroke victims with memory deficits could benefit from NF training as much as healthy controls. The used NF training protocols (SMR, Upper Alpha) had ...

5. neuroregulation.org neuroregulation.org/article/view/23459

Effectiveness of Neurofeedback Training in Poststroke ... This study assesses the efficacy of NFT in eight PSCI patients over 10 sessions (30 min/session) across 2 weeks with protocol based on qEEG for each patient.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11922947/

Efficacy and safety of brain–computer interface for stroke ... It has been proven that BCI-combined treatment can improve upper limb motor function and the quality of daily life for stroke patients.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1388245724002360

EEG-based sensorimotor neurofeedback for motor ... This scoping review maps research investigating EEG-based sensorimotor neurofeedback in adults and children with neurological motor impairments, including ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05884762

earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback ... The aim of this study is to evaluate the effect of early rehabilitation treatment by electroencephalographic neurofeedback on upper limb motor function after ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2590109524000594

Feasibility and Safety of a Home-based ... It is feasible and safe to conduct a home-based trial of a neurofeedback intervention for people with chronic neuropathic pain.