HINRI Labs Research

About HINRI Labs | Tracking Our Progress | Ignacio's Journey | Research

RESEARCH

Transcutaneous Electrical Stimulation - Published Studies

HINRI Labs was created in 2018 with a mission to change the standard of care for chronic, complete spinal cord injuries. Our goal is to work with our clinical, military, and university partners to identify and accelerate the most promising treatments, technologies and protocols that have successfully demonstrated neurological recovery of movement, function, and/or sensation. We want to then make those breakthroughs accessible to patients, prove their effectiveness, and change the standard of care. 

As you can read about below, we spent months literally traveling across the United States to visit the top research centers, leading laboratories and best rehab hospitals. We talked to as many experts as possible, both here in the US and across the world.

Based on our research, we feel confident that transcutaneous electrical stimulation offers the best opportunity to move us toward our goal.

We are partnering with Dr. Reggie Edgerton, the Director of UCLA’s Edgerton Lab, also known as the “father of neuromodulation.” Dr. Edgerton worked with the late Christopher Reeve after his spinal cord injury. Dr. Edgerton has been in the field for 53 years and is on the Scientific Advisory Board of the Christopher and Dana Reeve Foundation. He has been a leader in transcutaneous electrical stimulation. Here is a link to a few of his published studies. Dr. Edgerton and his colleagues performed the first implant of spinal epidural stimulation in human subjects with complete paralysis on Dec 7, 2009. This led to testing noninvasive means of stimulating the spinal circuitry.

Dr. Edgerton has found that the most logical interpretation of his research is that there are networks above, within, and below the lesion in a signiﬁcant number of individuals diagnosed with complete, chronic paralysis that can be transformed into a functional connectome by receiving a specific critical type and level of spinal modulation that enables these networks to be re-engaged.

Reasons we are excited about this opportunity:

Demonstrated success with chronic, complete patients 
Non-invasive (epidural electrical stimulation is another option, but it requires surgical implants and has not produced better outcomes)
Possible recovery of function and sensation 
Long-term results vs losing function after the trial or rehab are over
Focused on the whole-person / multiple targets (stepping, walking, arms (including plexus), fingers, trunk, blood pressure, bowel/bladder/sexual function, etc.)
Collaborative - Dr. Edgerton wants to work with the VA and is willing to help create a center in Atlanta

The image above is a conceptual design of how paraplegics move from a wheelchair to over-ground stepping. (Note these are simplified schematic for the sake of representation.) A) Wheelchair-bound patient with no voluntary control. B) Oscillation in a gravity-neutral environment. C) Dynamic standing with posture control. D) Over-ground weight-bearing stepping aided by exoskeleton or body weight supported treadmill. E) Over-ground stepping aided by rolling walker device with sufficient safety straps (not shown).

Here are some links to videos demonstrating some of Dr. Edgerton’s results:

Background

Currently in the US, after a complete spinal cord injury, patients are typically rushed home within a few weeks with a binder of instructions on how to live the rest of their lives paralyzed, in a wheelchair, in pain, fighting off infections, dealing with secondary complications, and with a substandard quality of life and life expectancy. They’re told their injury is too severe or “complete,” meaning that there’s no sensation, movement, or function below the break, and that because of this diagnosis they do not qualify for any treatment intervention or rehabilitation. They are also told that any potential recovery that could possibly occur once the spinal swelling has gone down would typically happen spontaneously during the first two years of the injury, but that anything beyond that is impossible. Even for those who have less severe incomplete injuries or those who do recover some function during those first two years rarely see significant, sustainable results. Insurance does not provide funding because recovery has never been thought possible – until now.

To explore and evaluate these solutions from various angles, Ignacio Montoya MS BME, began a comprehensive effort to travel across the country visiting the leading laboratories and rehab hospitals and talk to as many experts as possible.

After having sustained a spinal cord injury himself in December 2012, Ignacio focuses on neurorecovery on a daily basis and is committed to transforming lives and changing the standard of care for all spinal cord injuries. Ignacio recently graduated first in his class from Georgia Tech with a master’s degree in biomedical engineering and has also had extensive experience in changing the standard of care for peripheral nerve injuries at the Mayo Clinic. Ignacio has tested and evaluated various protocols and medical interventions on himself.

As part of our research, Ignacio, who is categorized as a chronic, complete (ASIA A) T-4 SCI, has developed protocols for intensive, activity-based rehabilitation. He has completed what he calls the 3/3/3 pre-intervention program – walking 3 hours a day, 3 days a week, for a total of 3 months on a robotic-assisted orthosis suspended over a treadmill, known as the Lokomat. In fact, in just over a year Ignacio has walked over 650 miles on the Lokomat, the most ever walked by anyone with paralysis.

We spent several months talking to the leading experts in the field of translational spinal cord injury research and asking each and every one of them the simple question: “How can we best accelerate your clinical work?” We visited and met with the following experts and institutions in an effort to refine our strategy and develop partnerships:

In addition, Ignacio visited with, spoke to, or participated in the following research programs:

One week in Fort Worth, Texas at the Neurological Recovery Center, where he met, shadowed, and implemented his own neurorecovery protocols using the new Lokomat FreeD with the staff MD, Dr. Brian Wood.
One week in Birmingham, Alabama at the Lakeshore Foundation where Paralympic athletes train to participate in a study evaluating the effects of meditation, mindfulness, exercise, and nutrition after a spinal cord injury.
One week in Louisville, Kentucky at the Frazier Rehab Center & Kentucky Spinal Cord Injury Research Center, where he participated in a week of screening and evaluation of his candidacy for an implanted electrical stimulator designed to excite and prime the spinal cord to relearn human locomotion. On this trip and several times since, he has spoken with Dr. Susan Harkema, president of the Christopher and Dana Reeve NeuroRecovery Network and the number one expert in the world on epidural electrical stimulation, to evaluate her research.
One week in Miami, FL at the Miami Project to Cure Paralysis, where he toured their new multi-million dollar rehabilitation facility opening later this year, which is next door to the Miami VA Medical Center. He met with their president and founder, Marc Buoniconti, and Scientific Director, Dalton Dietrich, to discuss their groundbreaking work on Schwann and stem cell therapy, as well as their work in collaboration with Dr. Reggie Edgerton in the area of transcutaneous electrical stimulation. They are very excited and looking forward to partnering with us.
Three days in Toronto, Canada at the Rick Hansen Institute (now called Praxis Spinal Cord Institute) Researchers Meeting, where he discussed the North American SCI consortium initiative and the upcoming goals for their new research program. He plans to visit their Vancouver headquarters in September and has been asked by their leadership to join their board.
One week in Chicago, IL at the Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago) where he met with Dr. Monica Perez and Dr. Francisco Benavides to test their transcutaneous electrical stimulation therapy on himself and tour their 1.2 million square foot facility that houses six human locomotion labs.
Ignacio returned to the Shirley Ryan AbilityLab in October of 2019 for seven weeks to participate in a clinical trial testing the effects of transcutaneous electrical stimulation on the spinal cord. After just 11 sessions he was able to voluntarily move his legs for the first time since his injury six years ago. (Here is a link to the video.)

Once we chose Dr. Edgerton's clinical trial as our best option, we were pleased to learn that Mary Kate Wold, the mother of one of our clinical trial patients (Peter), had utilized her extensive network and had come to the same conclusion. You can view a letter she wrote to the NIH here.

Our goal is to accelerate this and other technologies that help complete SCI patients regain their independence and change the standard of care so all patients have access to these breakthroughs. We will report our progress regularly on this website. Please follow our progress and help us spread the word!

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