20 Participants Needed

MI-Based Training for Stroke Survivors

DG
RR
Overseen ByRinku Roy, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: North Carolina State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Stroke is a leading cause of disability. Most stroke survivors face challenge in using their arm and hand to carry out daily task, such as grasping or holding objects. This issue makes it tough for nearly 65% of stroke survivors to return to work and take care of themselves. The cause of their disability is changes in their brain's activity patterns of the motor cortex area. Traditional therapy does not directly alter these brain changes, which makes it less effective. As a way to help stroke survivors, people are looking into ways to train the brain directly. A method they found is motor imagery, which involves mental practicing of a task. Studies suggest that this type of training can potentially alter the brain's patterns, which can be seen through EEG. An EEG shows a fixed pattern during movement, called SMR (sensory motor rhythm). Studies have found that people can learn to control this SMR through mental practice of a task. The SMR changes in a similar way during both movement and motor imagery. Therefore, mental practice of hand tasks can lead to improvement in actual hand movements. It has already been shown that stroke survivors can open their hands more easily after receiving SMR training. Along with that, they also have trouble to hold and release objects. SMR training may be able to address these issues by changing brain patterns. But it is not clear yet if SMR training can improve all three stages of grasping (open, close, release), and to what extent it can enhance overall hand function. This study plans to include 20 adults who have experienced a stroke and have ongoing problems with moving their hands. Half of these participants will take part in a training in which they will learn to control their SMR for three distinct hand tasks (open, close, and release). The first session will be followed by eight training sessions. To guide users toward specific changes in EEG activity, we will provide visual feedback in training. As soon as an appropriate EEG change is made, a hand exoskeleton will help them open and close their hand. The other group of 10 patients will have traditional therapy. They will do 9 sessions of hand exercises. During and after the training, we will test both groups to see how well their hand function improved. The result will help us determine which training method is better 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 data supports the effectiveness of the treatment Neurofeedback-based therapy for stroke survivors?

Research suggests that neurofeedback-based therapy, which involves training the brain to improve its function, can help stroke survivors recover motor skills. Studies show that this treatment can lead to changes in brain activity and improve motor function, especially when practiced regularly at home.12345

Is neurofeedback-based therapy safe for stroke survivors?

Research suggests that neurofeedback-based therapy is generally safe for stroke survivors, with studies showing that participants were able to engage in the therapy without reported adverse effects. The therapy has been associated with improvements in brain activity and motor function, indicating it is well-tolerated.12467

How does neurofeedback-based therapy differ from other treatments for stroke recovery?

Neurofeedback-based therapy for stroke recovery is unique because it uses real-time brain activity feedback to help patients improve motor function by practicing motor imagery (imagining movements) at home. This approach allows for frequent, personalized training that can enhance brain plasticity (the brain's ability to change and adapt) and improve motor skills, unlike traditional therapies that may not provide such direct feedback or flexibility.13489

Eligibility Criteria

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.
See 1 more

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.
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Neurofeedback - based therapy groupExperimental Treatment1 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 groupActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

North Carolina State University

Lead Sponsor

Trials
38
Recruited
50,000+

Findings from Research

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

References

High-Intensity Chronic Stroke Motor Imagery Neurofeedback Training at Home: Three Case Reports. [2018]
2.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Efficiency of a comprehensive program with biological feedback on support reaction in the restoring period of stroke]. [2022]
Laterality of brain activity during motor imagery is modulated by the provision of source level neurofeedback. [2014]
Graded fMRI Neurofeedback Training of Motor Imagery in Middle Cerebral Artery Stroke Patients: A Preregistered Proof-of-Concept Study. [2020]
The potential of real-time fMRI neurofeedback for stroke rehabilitation: A systematic review. [2019]
Self-modulation of motor cortex activity after stroke: a randomized controlled trial. [2022]
Neurofeedback as a form of cognitive rehabilitation therapy following stroke: A systematic review. [2022]
Toward an Adapted Neurofeedback for Post-stroke Motor Rehabilitation: State of the Art and Perspectives. [2022]
A Multi-Target Motor Imagery Training Using Bimodal EEG-fMRI Neurofeedback: A Pilot Study in Chronic Stroke Patients. [2020]
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