Technology Research & Analytics

NEUBIE Device Research Currently Underway

After learning about the NEUBIE, private practice owners are typically as interested as they are skeptical that it can provide the results promised. Luckily, several independent studies are underway to prove the longterm efficacy of the NEUBIE device for physical therapy. Here are several that NeuPTtech has been following:

Completed Projects:

Peer Reviewed University of South Florida Study 

In April 2022, a University of South Florida research team released a study showing substantial evidence that NEUBIE strength training provides similar gains to traditional muscle training with less work. This peer reviewed NEUBIE study was published in the Journal of Musculoskeletal and Neuronal Interactions and even featured Jason Waz of NeuPTtech as the Medical Director overseeing the use of the NEUBIE. The study continued on and all reports can be found below.

PT 1 of Study

PT 2 of Study

(Read NeuPTtech’s Blog on Study)

• Study Type: 2 Within Subjects Comparative Studies (one acute upper body focused and one long-term lower body focused)
• PI: Sam Buckner, PhD
• Location: University of South Florida (Tampa, Florida)
• # of participants: Unknown (still collecting data)
• Goal: Investigate the impact of Neubie in strength training on hypertrophy and blood flow.
• Acute Study: 24/48 hour time points post Neubie usage for hypertrophy. Measure echo intensity (as measure of blood flow), soreness, and torque pre/post test.
• Long term training study: 8 week training for muscle growth in the lower body. 2x a week within subject control for quad growth. Normal load on non-Neubie leg, half as much load on Neubie leg. Will measure muscle thickness.
• Current status: Data collection for both studies has been completed and study manuscript has been published.

NEUBIE Multiple Sclerosis Study (Read NeuPTtech's Blog on Study)

• Ellerbusch CL, Chapple KM, Seibert JB. A case series in individuals with multiple sclerosis using direct current electrical stimulation to inhibit spasticity and improve functional outcomes. Multiple Sclerosis Journal - Experimental, Translational and Clinical. 2023;9(3). doi: 10.1177/20552173231186512

• Multiple Sclerosis and its Impact: Multiple Sclerosis (MS) affects over 2.8 million people worldwide. A significant percentage of those with MS (66-84%) experience spasticity, which is characterized by an abnormal increase in muscle stiffness, cramping and loss of muscle tone. This condition often hampers movement and speech and may be accompanied by discomfort or pain.

• Current Treatments and Their Limitations: The treatments currently available for spasticity offer limited relief for MS patients. Researchers are now exploring electrical stimulation as a potential solution.

• NEUBIE's Potential: NEUBIE, a device using direct current electrical stimulation, shows promise in treating MS patients' spasticity based on pilot studies. This approach is believed to be more effective in addressing neuromuscular dysfunction in MS patients.

• Mechanics of Multiple Sclerosis: MS primarily affects the brain and spinal cord, which comprise the central nervous system (CNS). Specifically, it targets the protective myelin sheath of nerve fibers in the CNS. Damage to this sheath and the underlying nerve fibers can disrupt communication within the CNS, which may explain the heightened spasticity seen in MS patients.

• Research with NEUBIE: A recent study by Dr. Courtney Ellerbusch and Dr. Julie Seibert used the NEUBIE to treat seven progressive MS patients over 18 sessions in six weeks. The focus was on monitoring changes in muscle spasticity and functional strength. Notably, of the 126 planned sessions, 125 were completed. The results showed potential improvements in muscle spasticity and strength.

• Benefits Observed in the Study: Over 70% of subjects showed reduced bilateral spasticity. Two patients achieved the ability to stand without muscle cramping, a feat they hadn't accomplished in over three years. Three participants exhibited enhanced gait mechanics and increased their walking pace. Overall, NEUBIE demonstrated its potential to bolster strength and diminish spasticity in MS patients.

• NEUBIE vs. Traditional E-Stim: While traditional Transcutaneous Electrical Nerve Stimulation (TENS) has shown some efficacy in alleviating spasticity, the NEUBIE produced superior, more durable results. The NEUBIE's emphasis on direct current (DC) allows it to target specific areas and neural pathways more effectively than traditional e-stim, offering not only relief from spasticity but also potential in retraining and enhancing neuromuscular function. This offers MS patients hope for improved mobility and a higher quality of life.

NEUBIE Biostrap Study (Read NeuPTtech’s Blog on Study)

• Study Type: Commercial Within Subjects Study
• PIs: Ramona von Leden, PhD (NeuFit Director of Research) and Kevin Longoria (Biostrap Chief Science Officer)
• Location: NeuFit HQ (Austin, TX) & Competitive Edge Performance (Tampa, FL)
• # of Participants: 18
• Goal: To determine if regular use of Neubie as part of orthopedic rehab results in alterations to biometrics tracked by the Biostrap EVO wearable device. Biggest focus on biometrics related to sleep quality, recovery, arterial age and elasticity, heart rate variability, and oxygen consumption.
• Design: 7 week study – 2 week baseline, 4 week treatments 2x a week with Neubie for orthopedic pain, 1 week washout.
• Results: Neubie improved sleep efficiency, heart rate variability, range of motion, and decreased pain scores.
• Current status: Completed
• Press Release and Published Summary

Health in Motion (Read NeuPTtech’s Blog on Study)

• Study Type: Qualitative FOTO (Focus on Therapeutic Outcomes) Data Comparison
• PI: Ben Solheim, DPT, OCS, FAAOMPT
• Location: Health in Motion (Wausau, Wisconsin)
• # of participants: 523 cases
• Goal: Determine patient satisfaction and outcomes in orthopedic rehab cases that used Neubie for rehab sessions vs national FOTO database of cases that do not.
• Design: Multiple patient reported outcome measures which are comparable with other disability indexes.
• Current Status: Analyzing and preparing data for internal presentation.

Neuropathy Study 

In collaboration with Hands-On Diagnostics (HODS), NeuFit conducted a clinical trial comparing the NEUBIE device to conventional transcutaneous electrical nerve stimulation (TENS) devices for diabetic peripheral neuropathy.

• NeuFit's Innovative Approach:
  NeuFit has unveiled a groundbreaking way to treat neuropathy using the NEUBIE device, which leverages direct current (DC) electrical stimulation to improve recovery, alleviate pain, and enhance nerve function.

• Focus on the Nervous System:
  Unlike traditional neuropathy treatments that target structural issues, the NEUBIE device centers on optimizing the nervous system for more effective healing and functional recovery.

• Clinical Trial Collaboration:
  NeuFit partnered with Hands-On Diagnostics (HODS) for a clinical study comparing the NEUBIE device to conventional transcutaneous electrical nerve stimulation (TENS) devices.

• Key Study Findings:

  • The NEUBIE device demonstrated significant improvements in pain relief, motor function, sensory deficits, and nerve conduction.
  • TENS devices showed no notable benefits in these areas for patients with diabetic peripheral neuropathy.

• Impact on Neuropathy Treatment:
  The study highlights NEUBIE as a highly effective alternative to traditional therapies, offering a new paradigm in treating neuropathy by addressing the nervous system directly.

This breakthrough positions the NEUBIE device as a game-changer for neuropathy care and supports NeuFit’s mission to revolutionize physical therapy technology.

Ongoing Projects:

Orthopedic One

• Study 1 Type: Comparative Study
• PI: Eric Lenko, MPT, PhD, OCS
• Location: Orthopedic One (Columbus metro area, Ohio)
• # of participants: unknown
• Goal: Investigate quadricep fascicle length and pennation angle comparison between Neubie and Russian e-stim with and without an active contraction to determine any different in contraction of the quad within a patient’s tolerance. Utilize MSK imaging for data collection.
• Design: currently collecting data as pilot study to be used for full IRB proposal.
• Study 2 Type: Comparative Study
• PI: Kelley Holton, DPT, OCS
• Location: Orthopedic One
• # of participants: 30
• Goal: Comparison of 2500-Hz Burst Modulated Alternating Current and Pulsed Direct Current Electrical Stimulation on Isometric Knee Extension Torque. Additionally investigating evoked torque in combination with a voluntary contraction.
• Design:Subjects are tested over the course of two different sessions, with at least 5 days between testing sessions. Testing will be performed on subjects’ dominant leg, and takes roughly 30-40 mins. E-stim device used first is randomized.
• Current Status: Recruiting participants for second cohort.

Dell Medical School at UT Austin & Piazza Surgical Center

• Study Type: Interventional Clinical Trial
• Location: NeuFit HQ and Piazza Surgical Center (both Austin, TX)
• # of patients: 40
• Goal: To investigate the impact of a Neubie based post-operative training regimen on early recovery in abdominoplasty patients.
• Design: Start patients on recovery training at 1 week post-op, training is 2x a week for 6 weeks. Compare with control patients (no specific training regimen). Measure abdominal range of motion, strength, and perceived pain.
• Current Status: Recruiting

Integrative Functional Medicine

• Study Type: Pilot Case Study
• PI: Cynthia Hulsted, PhD
• Location: Private practice (Whidbey Island, WA)
• # of participants: 3-5
• Goal: To investigate the use of the Neubie for management of ALS and locked-in syndrome.
• Design: Protocol for restoring movement and function of musculoskeletal system in tandem with holistic medical practices.
• Current status: Preparing case study for submission for publication.

EMG/NCV Neuropathy Study

• Study Type: Interventional Randomized Clinical Trial
• PI: Dimitrios Kostopolous
• Location: Hands On PT (3 sites, Astoria, NY)
• # of participants: 150
• Goal: To determine effectiveness of Neubie foot bath protocol in alleviating numbness and pain associated with peripheral neuropathy, both acutely and long term.
• Design: Treatment will consist of 2-3 foot baths plus PT exercises a week for 5-6 weeks (a total of 12 visits). Experimental group will receive Neubie and PT; control will receive TENS and PT.
• Current Status: Under review for IRB approval.

Seminole College Master Reset Study

• Study Type: Interventional Clinical Trial
• PI: Francisco Cidral (Chief Science Officer, BrainTap)
• Location: Sanford, Florida
• # of participants: 15 per cohort (2-3 cohorts)
• Goal: To evaluate impact of regular Neubie master resets and BrainTap meditative training on overall sleep, recovery, and athletic performance.
• Design: Treatments 3x per week – 3 groups: Master Reset only, BrainTap training only, Master Reset + BrainTap training.
• Current status: IRB approved; Training staff on Neubie.

Upcoming Projects

Baylor Scott & White

• Study Type: Pilot Case Series
• PI: Nikita Nabar, DPT, NCS, GCS and Kathleen Lynch, PT
• Location: Baylor Scott & White Lakeway Campus (Lakeway, TX)
• # of participants: TBD
• Goal: Investigate the use of the Neubie in treating in patient recovery from stroke.
• Design: Protocol in development – focus is on treatment of vestibular system for balance issues and weakness.
• Current status: Pilot

St Joseph’s Hospital Post-operative Pain Study

• Study Type: Interventional Clinical Trial and retrospective analysis
• PI: Marcel Gourian, PT and associated physicians at St. Joseph’s
• Location: St. Joseph’s Hospital (Phoenix, AZ)
• # of participants: ~100
• Goal: To determine efficacy of Neubie for treatment of post-operative pain in 10 days following thoracic surgery
• Design: Post-op treatment for up to 10 days. Time points for measuring morphine usage at post-op day 2, 5, and 10. Retrospective comparison to morphine usage by patients previously seen at hospital to determine efficacy.
• Current Status: Preparing IRB application.

Tufts University Parkinson’s Disease Study

• Study Type: Interventional Clinical Trial
• PI: Linda Denney, DPT
• Location: Multiple Sites (Phoenix, Arizona)
• # of participants: TBD
• Goal: To evaluate efficacy of Neubie for treatment of Parkinson’s Disease related cognitive and motor deficits, and sleep.
• Design: Under development. May be combined treatment with boxing training and Neubie.
• Current status: Applying for grant funding.

Keystone Functional Restoration Program

• Study Type: Interventional Clinical Trial
• PI: Phil Hixson, DPT
• Location: Center for Interdisciplinary Spine (Sacramento, CA)
• # of participants: 10-12 per cohort (100+ total)
• Goal: To evaluate the impact of Neubie on pain, range of motion, and functional restoration in worker’s comp disability cases.
• Design: Program is an intensive 6 week rehabilitation program – 4 days per week of treatment and workshops. Patients will receive Neubie + PT exercises 2x a week for duration of program. Subjective and objective measurements will be recorded.
• Current status: Training staff on Neubie.

Heart Rate Variability Studies

STUDY: The NeuPT HRV Diagnostic System has Clinical Utility in Measuring Acute Responses to Integrative Therapies

The NeuPT HRV (Heart Rate Variability) Diagnostic System is a tool used in clinics to measure HRV and other health metrics. It’s widely used in Europe and U.S. physical therapy clinics but is being explored for broader use in other health practices, like acupuncture and massage therapy.

Findings:

• Reliable Baseline Measurements: The system shows consistent HRV readings when no treatments are performed, confirming its reliability.
• Therapy Impacts on HRV: Treatments like acupuncture and massage caused measurable improvements in HRV, aligning with previous research.
• Interest Beyond Physical Therapy: Non-physical therapy clinicians reviewed the system and agreed it could be useful for their practices.
• Potential for Broader Use: The study suggests the system could help track therapy effects in integrative medicine settings, though larger studies are needed to confirm these findings.

In short, the NeuPT HRV System is proving to be a valuable tool for understanding how therapies affect the body in real time and could expand its role in various healthcare fields.

Physical Therapy for Long COVID

Physical Therapy continues to serve a critical role during times of crisis when patients are more inclined to seek health and wellness solutions.

More and more clinics are implementing sanitation devices to ensure the safety of their staff and patients. Aerus ActivePure Technology is a guaranteed way to ensure 99.9% of viral pathogens on surfaces and in the air (including COVID-19) are eliminated.

Optimal Health services are leading the charge in helping patients recover. These services include:

• Heart Rate Variability (HRV)
• Pulsed Electro-Magnetic Field (PEMF)
• NEUBIE e-stim Therapy

Learn more about how Physical Therapy can help treat Long COVID.

The NEUBIE has been shown to have a profound effect on managing acute and chronic pain during countless clinical treatment applications. Physical Therapists have been recommended by the Centers of Disease Control to alleviate and manage pain involving the neck, shoulders, low back, and knees because:

• PT treatment within two weeks of a neck, knee, back, or shoulder injury reduces the odds of needing opioid pain killers by up to 60%
• 80% of patients with knee, back, and shoulder disorders remain opioid-free for at least one year after PT
• Increasing physical activity can reduce the risk of other chronic diseases

The body has the ability to heal itself when given the opportunity. Masking pain with opioids and other medications does not fix the underlying cause(s). Don’t medicate your pain. Treat it.