What side effects are associated with this type of intervention?

Common treatments involving Brain-Computer Interface (BCI) technology, such as the BCI-controlled robotic hand exoskeleton (IpsiHand), generally aim to facilitate motor improvement in patients with conditions like stroke. Known side effects of BCI treatments can include mild to moderate discomfort at the electrode sites, headaches, fatigue, and in rare cases, skin irritation or infection. Additionally, there may be psychological effects such as frustration or anxiety related to the learning curve and the effort required to control the BCI system effectively.

What prior FDA approvals exist?

As of now, there are limited FDA approvals specifically for Brain-Computer Interface (BCI) technologies aimed at motor improvement. One notable approval is for the BrainGate system, which is designed to help individuals with severe motor impairments control external devices using neural signals. This system has been used in clinical trials to facilitate communication and control of robotic limbs. The IpsiHand device, which is currently under study, represents a similar approach by using BCI to control a robotic hand exoskeleton to improve motor function in stroke patients.

What other types of research exist?

Promising novel alternatives to the BCI-controlled robotic hand exoskeleton (IpsiHand) for BCI patients include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown potential in improving motor function in stroke patients. 2) Non-invasive neuromodulation techniques, such as transcranial magnetic stimulation (TMS), which can enhance motor recovery. 3) Advanced wearable technologies for tremor suppression, which can aid in motor control. These alternatives leverage different mechanisms to facilitate motor improvement and may offer complementary or standalone benefits for BCI patients.

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Procedure

BCI-Controlled Robotic Exoskeleton for Stroke

N/A

Waitlist Available

Research Sponsored by Neurolutions, Inc.

Eligibility Criteria Checklist

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

Must have

Adults age (18-85)

Adults who sustained a CVA

Must not have

Participants who are too cognitively impaired to understand the task or provide informed consent will be excluded. A Short-Blessed Test score of 8 or more will be excluded.

Participants receiving any formal upper extremity therapy will be excluded.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 week assessment (outcome assessment)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a remote therapy that helps stroke patients move their hands using brain signals to control a robotic device. It targets patients with ongoing movement difficulties on one side of their body. The system works by detecting brain signals and moving a robotic hand to aid in motor skill improvement.

Who is the study for?

This trial is for adults aged 18-85 who have had a stroke and now experience weakness or paralysis in one arm. They should not be receiving other upper extremity therapies, have severe cognitive impairments, contractures that prevent device use, certain communication difficulties, or conditions affecting pain sensation.

What is being tested?

The study compares the effectiveness of a home-based brain-computer interface therapy using the IpsiHand System against standard exercises for improving arm function after stroke. Participants will either use the BCI-controlled robotic hand exoskeleton at home or follow an exercise program.

What are the potential side effects?

Potential side effects may include discomfort from wearing the exoskeleton device and fatigue due to exercise therapy. There might also be skin irritation where the device attaches to the hand.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 85 years old.

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I have had a stroke.

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I have weakness or paralysis in one arm.

Exclusion Criteria

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

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I understand the study and can consent. My Short-Blessed Test score is below 8.

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I am not currently undergoing any upper limb therapy.

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I do not have ataxia, apraxia, or severe psychiatric conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline assessment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Upper Extremity Remote Fugl-Meyer

Secondary study objectives

Gross Grasp Strength

Motor Activity Log

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of Care - Home Exercise Program for Upper ExtremityExperimental Treatment1 Intervention

Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Once randomized, the participant will be assigned to group 2 to begin standard of care treatment at home. Phase 2: After being assigned to Group 2, subjects will serve as the control group in the study. Subjects will receive a customized home range of motion exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks to control for the non-specific motor and sensory effects of BCI training. To help ensure compliance with the at-home portion of the protocol in the control group, participants will receive daily virtual monitoring from the study clinical specialist.

Group II: BCI treatment Group using the IpsiHandExperimental Treatment1 Intervention

Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Subjects will undergo an EEG screening protocol to ensure that a consistent control signal will be present to control the IpsiHand device. After an EEG screening session is complete, the participants screening data will be analyzed to ensure that sufficient cortical signals are present. Randomization for assignment to group 1 or 2 will then occur. Once assigned to group 1, if consistent signals are found, the participant will then continue to Phase 2. Phase 2: Group 1 subjects will be provided with a Neurolutions IpsiHand BCI system, which combines a novel powered exoskeleton with a commercial EEG amplifier and active electrode system. The exoskeleton opens and closes the patient's hand in a three-finger pinch grip. Patients will use the BCI system on a minimum of 5 days per week for 12 weeks. Patients will complete five or more 10-minute runs of the BCI task per day.

0 / 6Eligibility 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

Brain-Computer Interfaces (BCIs) facilitate motor improvement by detecting and interpreting brain signals, typically through electroencephalography (EEG), and translating these signals into commands for external devices like robotic exoskeletons. This process captures the user's intent to move, processes these signals through specialized algorithms, and actuates the robotic device to perform the desired movement. This mechanism is vital for BCI patients as it creates a direct communication pathway between the brain and the device, bypassing damaged neural pathways and enabling the restoration of motor functions.

EEG-guided robotic mirror therapy system for lower limb rehabilitation.Performance assessment of a brain-computer interface driven hand orthosis.