Brain Machine Interface (BMI) in Subjects Living With Quadriplegia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study, investigators will show proof-of-concept that brain signals can be used in real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the motor cortex. These electrodes implanted in the brain will enable bioelectrical data recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data will be

1. either processed in the Activa PC+S; or
2. off-loaded via the Nexus D communication device (Medtronic) to a computer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

NCT01364480

Tetraplegia Spinal Cord Injury

TERMINATED NA

Providing Brain Control of Extracorporeal Devices to Patients With Quadriplegia

NCT01849822

Tetraplegia

COMPLETED NA

Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton

NCT02550522

Traumatic Tetraplegia with Cervical Cord Injury

RECRUITING NA

Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients

NCT00004415

Quadriplegia

TERMINATED NA

Neuroplasticity After Spinal Cord Injury

NCT02446210

Spinal Cord Injury

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Medtronic Activa PC + S is a multi-programmable primary cell neurostimulator that records bioelectric data and deliver electrical stimulation through leads implanted in the brain.

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Participants will be undergoing a unilateral implantation of the Medtronic Active PC+S with unilateral subdural strip electrodes over the motor cortex. They will receive 24 sessions over a 3-6 month period which consists of external stimulation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Medtronic Activa PC+S

Objective of this pilot phase early feasibility study is to assess the safety and feasibility of Medtronic Activa PC+S implant (device) by;

1. Evaluating the ability of the Activa PC+S system to sense ECoG signals in subjects living with quadriplegia (C5 or C6 level).
2. Assessing the feasibility of activating fundamental upper extremity muscles to reproduce hand grasp.

These are important first steps towards creating and designing a device that can enhance or assist in performing activities of daily living (ADL) in the life of these subjects. Attachment 15.3

Group Type EXPERIMENTAL

Medtronic Activa PC+S

Intervention Type DEVICE

Upon consent, the good candidates will undergo surgical screening that includes a full neurological workup and baseline functional assessment. Subjects that demonstrate feasibility for control will undergo surgery for unilateral implantation of the Activa PC+S as well as the implantation of unilateral subdural strip electrodes (Resume II, model 3587A) over the motor cortex. After 24 hour observation in the hospital, subjects will participate in 24 distinct sessions or visits of testing over a 3-6 month period. During these visits, the sensing, decoding of the implanted device (Activa PC+S) as well as the external stimulation components (Bioness H200) and parameters will be tested and benchmarked. Subjects will participate for 24 sessions and continue to participate in the study until the end of life of the device, at which point the subject may elect to undergo an explant at that time.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Medtronic Activa PC+S

Upon consent, the good candidates will undergo surgical screening that includes a full neurological workup and baseline functional assessment. Subjects that demonstrate feasibility for control will undergo surgery for unilateral implantation of the Activa PC+S as well as the implantation of unilateral subdural strip electrodes (Resume II, model 3587A) over the motor cortex. After 24 hour observation in the hospital, subjects will participate in 24 distinct sessions or visits of testing over a 3-6 month period. During these visits, the sensing, decoding of the implanted device (Activa PC+S) as well as the external stimulation components (Bioness H200) and parameters will be tested and benchmarked. Subjects will participate for 24 sessions and continue to participate in the study until the end of life of the device, at which point the subject may elect to undergo an explant at that time.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* AIS Grades A \& B
* Level of Injury C5 or C6
* Local Community dwelling
* Stable chronic injury
* Stable health status and upper extremities
* Completion of Clinical Protocol 01