EEG Brain-Machine Interface Control of an Upper-Limb Robotic Exoskeleton for Robot-Assisted Rehabilitation After Stroke (NeuroExo)

University of Houston

Status: Unknown

Conditions: Stroke; Hemiparesis

Treatments: Device: NeuroExo co-robot neurorehabilitation system

Study type: Interventional

Funder types: Other

Identifiers

NCT05374486

G0501521

HSC-MS-20-1287 (Other Identifier)

Details and patient eligibility

About

The goal of this study is to develop a clinically feasible, low-cost, nonsurgical neurorobotic system for restoring function to motor-impaired stroke survivors that can be used at the clinic or at home. Moreover, another goal is to understand how physical rehabilitation assisted by robotic device combined with electroencephalograph (EEG) can benefit adults who have had stroke to improve functions of their weaker arm.

The proposed smart co-robot training system (NeuroExo) is based on a physical upper-limb robotic exoskeleton commanded by a non-invasive brain machine interface (BMI) based on scalp EEG to actively include the participant in the control loop .

The study will demonstrate that the Neuroexo smart co-robot arm training system is feasible and effective in improving arm motor functions in the stroke population for their use at home.The NeuroExo study holds the promise to be cost-effective patient-centered neurorehabilitation system for improving arm functions after stroke.

Full description

This study has two phases: The first phase will consist of baseline recordings for system calibration and training sessions to be conducted in a clinical setting. The second phase will consist of NeuroExo BMI-exo neurotherapy to be conducted at the participant's home. Throughout the study and after completion of the study, movement and brain activity will be analyzed to assess function of the affected upper extremity and changes in brain activity associated with the neurotherapy.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects between the ages of 20-65, male or female,
• mild-to- moderate unilateral stroke confirmed by brain CT or MRI scan and manifested by a Glasgow Coma scale (GCS) score between 15 and 9 documented within 6 months,
• the ability to perform 20deg of active wrist/elbow for upper limb robotic movement on the affected side, no planned alteration in lower/upper- extremity therapy/medication for muscle tone during course of study,
• Anticipated length of needed acute interdisciplinary rehabilitation of 30 days or more.
• Patients are required to have a MMSE>=24 to rule out those with cognitive impairments.
• Patients will have to have normal/near normal strength in one upper/lower extremity and appreciable weakness in the other upper/lower extremity.

Exclusion criteria

• history of traumatic brain injury prior to the current episode,
• Severe neurologic or psychiatric condition preventing participation in rehabilitation and physical therapy activities (patients unable or unwilling to receive instruction and effectively complete a simple assigned task as determined by MMSE>=24 specified in inclusion criteria).
• Women and minorities will be recruited as long as they meet the inclusion criteria.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

NeuroExo

Experimental group

Description:

NeuroExo is a device which includes a robotic exoskeleton that you were in your affected arm to assist you with arm movements, a headset that you wear on your head to measure your brain activity and detect your intention to move, and a graphical user interface that allows you to initiate and stop neurotherapy, and track your motor performance.

Treatment:

Device: NeuroExo co-robot neurorehabilitation system