A study of an investigational device for upper limb paralysis due to spinal cord injury

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Regain Function. Restore Life.

More than 5 million people in the United States are living with functional paralysis due to various causes including spinal cord injuries.1 It is estimated that over 1.2 million Americans are suffering from paralysis as the result of a spinal cord injury. In addition to paralysis, spinal cord injury survivors often suffer from many other medical complications, including chronic pain, depression, pressure sores, circulatory problems, respiratory problems, pneumonia, autonomic dysfunction, muscle spasticity, bladder and bowel dysfunction, and sexual dysfunction.2

There is currently no cure for spinal cord injuries. The current standard of care includes pharmacological, surgical, and rehabilitative treatments. Pharmacological treatments are targeted at alleviating symptoms and minimizing comorbidities. Depending on the injury, surgical options may be considered, and most patients are treated with a rehabilitation program to combine physical therapy and mental support.

Rehabilitation programs involve a team of clinical professionals and may be assisted by medical devices including walkers, braces, wheelchairs, assisted gait training devices, neural prostheses, and muscle stimulators. ANEUVO is developing a new type of neuromodulation technology to complement rehabilitation programs for chronic spinal cord injury individuals.

If you are considering participation in the ASPIRE study, please complete a brief questionnaire to see if you may qualify. If eligible, the participating study site in your area will reach out to schedule a visit to conduct additional assessments and to answer any questions you may have.

It is important to carefully consider the study time commitment before agreeing to participate.

ASPIRE Clinical Study

A study of an investigational device for upper limb paralysis due to spinal cord injury

Expert rehabilitation centers throughout the U.S. are participating in the ASPIRE (Assessing non-invasive spinal Stimulation and PT/OT for motor Improvement Response with ExaStim®) clinical study. The purpose of this research is to study transcutaneous spinal stimulation in combination with traditional rehabilitation therapy as an adjunct therapy to rehabilitation for patients living with upper extremity paralysis due to spinal cord injury (SCI).

Participants in this study must:

  • Meet the inclusion criteria

  • Adhere to the 13-week study period

  • Attend 8 weeks of rehabilitation therapy (3 sessions per week)

  • And be available for follow-up visits

Those patients who meet the criteria for participation will be scheduled for an in-person assessment by the clinical study team to determine final eligibility to participate in the study. During the study period, patients will be randomized to the active stimulation + rehabilitation therapy group or the rehabilitation-alone therapy group. The study site will not tell patients which group they have been selected for after being accepted into the study.

About the System

What is Transcutaneous Spinal Stimulation (TSS)?

Transcutaneous spinal stimulation (also called neurostimulation) is a non-invasive medical therapy that doctors are investigating to improve or restore motor function in patients who are experiencing limited function or paralysis due to a chronic spinal cord injury.

Neurostimulation works by modulating the spinal cord circuitries. To do this, electrodes are externally placed on a patient’s back, and electrical stimulation is delivered via the electrodes by a portable pulse generator (PPG). This system is used to facilitate motor function recovery.

ExaStim® TSS System

The ExaStim TSS system is an investigational multi-electrode system that offers an alternative to available methods and may help to improve and optimize treatment for patients with spinal cord injury. Like other neurostimulation systems, the ExaStim system consists of three basic parts that are designed to work together to help improve motor function: a portable pulse generator, external electrodes, and a patient programmer.

ExaStim®

Portable Pulse Generator (PPG)

A portable stimulation device that holds the battery and electronics and sends pulses of electricity to the electrodes.

Electrodes

A multi-electrode pad that delivers the pulses from the power source (PPG) to nerves along the spinal cord

Programmer

An Android‡ application used on a provided mobile digital device that allows stimulation programs to be set and saved. Settings are communicated wirelessly through a Bluetooth® connection from the tablet to the PPG stimulation device.

Do I Qualify?

The ASPIRE study has specific rules on who can participate, how many can participate, and what procedures must be followed during the study.

You may be able to participate if you:

  • Are 22 years of age or older

  • Have a traumatic, chronic* spinal cord injury between levels C2 and T2

  • Have limited function of upper extremities

Frequently Asked Questions (FAQs)

If eligible to participate in the ASPIRE study, patients will

  • Contribute to the understanding of transcutaneous spinal stimulation (TSS) for upper extremity paralysis due to spinal cord injury
  • Work with an experienced and knowledgeable rehabilitation therapist and team of healthcare professionals
  • Possibly help the SCI community and others by increasing the medical community’s knowledge about the effects of TSS on motor improvement in an effort to improve SCI standard of care

Clinical studies are designed to evaluate the safety and effectiveness of investigational drugs and devices. All clinical studies involve some risk. All potential participants will be given an informed consent form, which provides detailed information about the study procedures, risks, and potential benefits. Skilled healthcare professionals are available at each center to answer all of your questions before you make your decision to participate in the study. Only doctors with experience in treating paralysis with TSS have been selected for this study.

Complete the online pre-screener [HERE – hyperlink, bolded larger font]. Patients who meet the initial qualification requirements will have their information sent to a study center. The staff at the study center will then contact you to discuss your candidacy for this study.

Participants should consider the study time commitments and their ability to see the study doctors as required before agreeing to participate. The study visits include:

Screening/Baseline Period

One week screening/baseline evaluation period. During the first week, screening will be completed, and baseline measurements will be recorded to determine eligibility. This may require more than one office visit.

Active/Sham Therapy Period

Eight-week period. Over the active/sham therapy period, eligible patients will have three weekly rehabilitation therapy sessions (S1, S2, and S3) targeting upper limb function over the course of 8 weeks for a total of 24 sessions. Each therapy session will last up to two hours, with a minimum of 30 minutes and maximum of 60 minutes of standard rehabilitation therapy. Additional time will be required during a fourth weekly session (S4) on weeks four, and eight to complete additional study assessments. These S4 study visits are anticipated to take up to three hours.

Patients will be randomly assigned to the Sham group or Active group. Patients in the Sham group will receive sham stimulation therapy in combination with standard physical/occupational therapy. Patients in the Active group will receive ExaStim® TSS therapy in combination with standard physical/occupational therapy. Both patients and clinical assessors will be blinded (or unaware) of which group a patient has been assigned to.

Therapy programs will be tailored to each patient’s level of SCI, medical history, and personal therapy goals.

Follow-Up Period

Three-week follow-up period. Three weeks after therapy is complete, patients will return for one follow-up visit to complete exit assessments.

The study sponsor is covering study-related visit costs and costs associated with receiving ExaStim® therapy. However, the study site does not have a program to pay you if you are hurt or have other bad results from being in the study. Standard medical care is open to you as it is to all sick or injured people.

The study sponsor, ANEUVO, does not have a program to pay you if you are hurt or have other bad results from being in the study. However, ANEUVO has agreed to pay the usual and standard costs of urgent, necessary treatment you receive as a direct result of any study-related physical side effects, complications, or injuries. If eligible to participate in the study, please review in detail the informed consent form for additional information on reimbursement eligibility specific to study-related physical side effects, complications, or injuries.

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About ANEUVO

ANEUVO is a platform and therapy development company made up of an interdisciplinary team of expert engineers, renowned scientists and researchers, clinicians and physicians, collaborating on new innovations for chronic conditions and injuries that have not been curable through traditional pharmaceutical and rehabilitation approaches.

CAUTION – Investigational device limited by federal law to investigational use.

*Chronic injury shall be defined as either (1) 12 months since initial injury or (2) a preceding six months of no significant change in motor function (<2.72 points in ISNCSCI Upper Extremity Motor Score)
1Source: Armour BS, Courtney-Long EA, Fox MH, et al. Prevalence and causes of paralysis—United States, 2013. Am J Public Health. 2016;106(10):1855-7.
2Spinal Cord Injury: Hope Through Research. Available at: https://www.ninds.nih.gov/Disorders/Patient-Caregiver- Education/Hope-Through-Research/Spinal-Cord-Injury-Hope-Through-Research Accessed 08 Jan 2020

‡ Indicates a third party trademark, which is property of its respective owner

Bluetooth is a registered trademark of Bluetooth SIG, Inc.

Locations

 Additional sites will be joining the ASPIRE Clinical Study.
Check back often!

WEST

UTAH

Neuroworx
Salt Lake City, UT

CENTRAL

ILLINOIS

Shirley Ryan AbilityLab
Chicago, IL

TRYAbility
Chicago, IL

WISCONSIN

Marquette University
Milwaukee, WI

NORTHEAST

MARYLAND

Kennedy Krieger Institute
Baltimore, MD

NEW YORK

Mount Sinai
New York City, NY

SOUTH

TEXAS

Houston Methodist Research Institute
Houston, TX