What is the mechanism of action of this treatment?

The most common treatments for stroke that promote neuroplasticity and motor recovery include physical therapy, occupational therapy, and task-specific training. These therapies work by engaging the brain in repetitive, goal-oriented tasks that stimulate neural pathways and encourage the brain to reorganize and form new connections, a process known as neuroplasticity. This is crucial for stroke patients as it helps restore lost motor functions and improves overall physical and cognitive recovery. Virtual Reality (VR) enhances these effects by providing an immersive environment that can make the exercises more engaging and effective, thereby potentially accelerating the rehabilitation process.

What side effects are associated with this type of intervention?

Common treatments for stroke that promote neuroplasticity and motor recovery, such as physical and occupational therapy, generally have minimal side effects but can include muscle soreness and fatigue. Neuromodulation techniques like transcranial magnetic stimulation (TMS) may cause mild side effects such as lightheadedness, tingling, and tinnitus. More serious side effects are rare but can include seizures, particularly in patients with epilepsy. Overall, these treatments are considered safe and effective for improving motor function post-stroke.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke that involve neurostimulation and neuromodulation, which are similar to the mechanisms used in Virtual Reality (VR) for promoting neuroplasticity and motor recovery. For instance, transcranial magnetic stimulation (TMS) has been approved for various neurological conditions and is being explored for stroke rehabilitation. TMS uses magnetic fields to stimulate nerve cells in the brain, which can enhance motor recovery and neuroplasticity. Additionally, noninvasive vagus nerve stimulation (nVNS) has shown potential benefits in stroke recovery by modulating brain activity and promoting neuroplasticity. These treatments align with the principles of VR-based therapies that aim to improve motor function through targeted, task-specific training.

What other types of research exist?

Promising novel alternatives to VR for stroke patients in 2024 include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells and promote neuroplasticity; 2) Transcranial Direct Current Stimulation (tDCS), which applies a low electrical current to the scalp to enhance motor recovery; 3) Digital therapeutics, such as game-based interventions approved by the FDA, which improve attention and cognitive functions; and 4) Telerehabilitation, which provides remote, personalized rehabilitation programs through digital platforms.

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VR Therapy for Stroke Rehabilitation

N/A

Recruiting

Led By Virginia Chu, PhD

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The absence of upper extremity injury limiting functional use of the arm prior to the incident stroke

Age 18 or older

Must not have

Pain in the involved upper limb that could interfere with daily activities as evidenced by a pain score of 5 or greater on the Numeric Pain Rating Scale

History of greater than two strokes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to approximately 12 days

Awards & highlights

Summary

This trial looks at how well Virtual Reality (VR) and exercises can help people with stroke regain arm movement. #VR #StrokeRehab

Who is the study for?

This trial is for adults over 18 who had a stroke at least 6 months ago and have limited arm movement because of it. They must not be doing Yoga or Tai-Chi during the study, should have no severe cognitive issues, and can't have had multiple strokes or conditions like cyber-sickness that could affect participation.Check my eligibility

What is being tested?

The study tests how well immersive Virtual Reality (VR) therapy combined with specific tasks helps improve arm function in people who've had a stroke. It looks to see if this high-tech approach encourages more arm movement than traditional methods.See study design

What are the potential side effects?

Potential side effects may include discomfort from wearing VR equipment, dizziness or nausea due to motion sickness within the virtual environment (known as cyber-sickness), and fatigue from performing tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My arms were fully functional before my stroke.

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I am 18 years old or older.

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I can't fully move my shoulder, elbow, or wrist because of an injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I experience significant pain in my arm that affects my daily activities.

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I have had more than two strokes.

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I cannot put on or take off a fitness tracker by myself and have no one to help me.

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I have a history of seizures.

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I am unable to understand and give consent for treatment.

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I had a stroke less than 6 months ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to approximately 12 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to approximately 12 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to approximately 12 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in hemiplegic arm movements

Trial Design

1Treatment groups

Experimental Treatment

Group I: Virtual reality (VR) therapyExperimental Treatment1 Intervention

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for stroke that promote neuroplasticity and motor recovery include physical therapy, occupational therapy, and task-specific training. These therapies work by engaging the brain in repetitive, goal-oriented tasks that stimulate neural pathways and encourage the brain to reorganize and form new connections, a process known as neuroplasticity. This is crucial for stroke patients as it helps restore lost motor functions and improves overall physical and cognitive recovery. Virtual Reality (VR) enhances these effects by providing an immersive environment that can make the exercises more engaging and effective, thereby potentially accelerating the rehabilitation process.

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

702 Previous Clinical Trials

22,886,776 Total Patients Enrolled

2 Trials studying Stroke

2,020 Patients Enrolled for Stroke

Virginia Chu, PhDPrincipal InvestigatorVirginia Commonwealth University

~1 spots leftby Sep 2024

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