DME.00052 Brain Computer Interface Rehabilitation Devices

This document addresses brain computer interface (BCI) rehabilitation devices. These are non-invasive devices designed to enable individuals, particularly those with neurological conditions such as stroke, to control external devices using their brain signals.

Note: For further information on similar technologies, please see the following related document:

Brain computer interface rehabilitation devices, including but not limited to electroencephalography (EEG)-driven upper extremity powered exercisers, are considered investigational and not medically necessary.

To date, only one brain-computer interface device has been successfully reviewed by the Food and Drug Administration (FDA), the IpsiHand™ Upper Extremity Rehabilitation System. No studies evaluating the impact of the IpsiHand system on health outcomes have been published in a peer-reviewed journal.

A preliminary study examined changes in the coordination of brain rhythms during use of the IpsiHand system (Rustamov, 2022). The study included 17 individuals who had a stroke at least 6 months prior to study participation. Other eligibility criteria included intact cognitive ability, unilateral upper extremity weakness and normal sensation in the affected upper extremity. Participants used the IpsiHand system for 12 weeks as part of a rehabilitation therapy program. Brain signal measurements were taken at the beginning of therapy and every 4 weeks during therapy. The investigators found that the coordination between theta and gamma brain rhythms improved in both left and right brain regions controlling movement, and the improvement in brain rhythms were associated with improvements seen during therapy sessions.

The study was not designed to evaluate whether use of the IpsiHand system improved clinical outcomes. It did not include a control group of individuals who did not use the Ipsihand system and therefore it is unclear whether changes in motor functioning were due to the use of the device or some other factor such as added attention given to trial participants.

Currently, there is insufficient credible evidence in the published literature to show that use of brain-computer interface rehabilitation devices such as the IpsiHand system improves net health outcomes outside of a research setting.

BCI rehabilitation devices are technologies that detect brain signals related to the intent for movement and can then use these signals to control a limb, computer or digital device. Many types of BCI systems are in development and/or undergoing clinical trials. One of the primary potential applications of BCI technology is as an aid for motor recovery in individuals who have had a stroke, such as by translating brain signals into movement of paralyzed limbs or into the control of othotic devices.

At least one BCI device is commercially available. It is used as an aid in post-stroke upper limb rehabilitation. This device, the IpsiHand Upper Extremity Rehabilitation System (Neurosolutions, Inc.) went through the FDAs de Novo classification process and, in April 2021 was classified as a type II device with the generic name of an electroencephalography (EEG)-driven upper extremity powered exerciser (DEN200046). The device type was defined as a “non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain”. The FDA de Novo classification process did not require that clinical data be submitted demonstrating that the device improves the net health outcome.

The Neurolutions IpsiHand Upper Extremity Rehabilitation System is indicated for use in chronic stroke patients (≥ 6 months post-stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity.

The IpsiHand system consists of 3 components, a headset, a tablet and a handpiece. The non-invasive EEG headset is designed to measure electrical signals from the uninjured side of the brain regarding the user’s intention to move the affected hand. The EEG data is transmitted wirelessly to the tablet, which serves as an interface between the headset and hanpiece. A signal is sent to the wireless handpiece via the tablet, and the handpiece then opens or closes the user’s hand. The system may be used as part of a rehabilitation program to help the user improve grasping, with the tablet guiding therapy sessions.

Brain computer interface: A system that enables direct communication between the brain’s electrical signals and an external output device that allows the user to perform a specific action.

Electroencephalography (EEG): A neurodiagnostic procedure that uses electrodes attached to the scalp to record electrical activity in the brain.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure code, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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Subject: Brain Computer Interface Rehabilitation Devices
Document #: DME.00052	Publish Date: 10/01/2024
Status: New	Last Review Date: 08/08/2024

HCPCS
E0738	Upper extremity rehabilitation system providing active assistance to facilitate muscle re-education, include microprocessor, all components and accessories

ICD-10 Diagnosis
	All diagnoses

Status	Date	Action
New	08/08/2024	Medical Policy & Technology Assessment Committee (MPTAC) review. Initial document development.