ENTF Neuromodulation Yields Reduced Disability After Stroke: An Individual Participant-Level Data Meta-Analysis

 Reduces is NOT GOOD ENOUGH! I expect more from superstar stroke researchers like Steven C. Cramer

Dr. Steven Cramer (25 posts to October 2011)

ENTF Neuromodulation Yields Reduced Disability After Stroke: An Individual Participant-Level Data Meta-Analysis

Jeffrey L. Saver, MD https://orcid.org/0000-0001-9141-2251 jsaver@mednet.ucla.edu, Joel Stein, MD https://orcid.org/0000-0001-5527-025X,

Steven C. Cramer, MD, MMSC https://orcid.org/0000-0002-6214-6211, Pamela W. Duncan, PhD https://orcid.org/0000-0002-4838-3253, 

Batsheva Sarah Weisinger, MS https://orcid.org/0000-0002-2409-617X, Dharam P. Pandey, PhD https://orcid.org/0009-0005-6525-7514, and Natan M. Bornstein, MD https://orcid.org/0000-0002-4442-8637Author Info & Affiliations

Stroke

New online

https://doi.org/10.1161/STROKEAHA.125.054959

Abstract

BACKGROUND:

Electromagnetic network-targeted field (ENTF) brain stimulation therapy is a promising approach to reduce poststroke disability. Two pilot, randomized, sham-controlled trials showed safety and signals of efficacy. The aim of this study was to perform a pooled analysis with greater statistical power to characterize with precision the effect of ENTF in promoting recovery and reducing disability.

METHODS:

We pooled individual patient-level data from 2 double-blind, randomized, sham-controlled studies, BQ3 (BrainQ3 Trial; Unique identifier: NCT04039178) and EMAGINE 1 (Electromagnetic Field Ischemic Stroke-Novel Subacute Treatment Trial; NCT05044507). Key entry criteria in both trials were (1) 4 to 21 days post-ischemic stroke and (2) Fugl-Meyer assessment-upper extremity score of 10 to 45. For EMAGINE 1, an additional criterion was a study entry modified Rankin Scale (mRS) score of 3 to 4. The primary outcome for this pooled analysis was freedom-from-disability (mRS score, 0–1) at 8 to 12 weeks. Secondary outcomes were level of disability (ordinal mRS score distribution), disability (mRS score) change from entry to 8 to 12 weeks, and 2 focused upper extremity motor end points.

RESULTS:

Altogether, 124 patients were included (active n=65; sham n=59). The mean age was 58.2±13.1 years, 31% were female, the study entry Fugl-Meyer assessment-upper extremity score was 25.3 (±10.6), and the therapy started 14.5 (±4.9) days poststroke. The study entry mRS score was 3.9 (±0.36), and 123/124 (99.2%) had a study entry mRS score of 3 to 4. Study entry features were well-balanced across treatment groups. At 8 to 12 weeks, freedom-from-disability was higher with active ENTF than sham stimulation (33.8% versus 11.9%; P=0.005). Ordinal shift across 3 disability strata (mRS score, 0–1, 2, and >2) also favored ENTF (P=0.009). Focused upper extremity motor end points nonsignificantly favored ENTF. Safety analyses showed no device- or procedure-related serious adverse events.

CONCLUSIONS:

In pooled data from 2 randomized, sham-controlled trials, treatment with ENTF compared with sham for patients with subacute ischemic stroke with moderate-severe study entry disability yielded increased achieved freedom-from-disability, greater disability improvement from study entry, and reduced final disability level. These findings, together with an attractive safety profile, support ENTF as a promising therapy for stroke recovery.

Graphical Abstract

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FDA clears Bioness Medical’s neuromodulation system for stroke rehabilitation

 

Will your competent? doctor and hospital be DOING ANYTHING WITH THIS?

Do you prefer your doctor, hospital and board of director's incompetence NOT KNOWING? OR NOT DOING? Your choice; let them be incompetent or demand action!

FDA clears Bioness Medical’s neuromodulation system for stroke rehabilitation

Bioness’s PoNS system is designed to improve gait impairment in stroke patients by stimulating the trigeminal and facial cranial nerves.

Bioness Medical’s oral neuromodulation system for rehabilitating stroke patients with gait deficits has secured clearance from the US Food and Drug Administration (FDA). The California-based company’s portable neuromodulation stimulator (PoNS) system delivers neurostimulation through a mouthpiece placed on the tongue. Designed for at-home use in conjunction with physical rehabilitation, the prescription-only device stimulates branches of the trigeminal and facial cranial nerves, activating direct connections to the brainstem. This treatment approach promotes the development of new neural networks to compensate for impaired corticospinal pathways, with the aim of improving walking function in individuals following a stroke, Bioness stated. The device’s clearance for stroke rehabilitation was supported by Bioness’s three-study Stroke Registrational Program (SRP) that evaluated PoNS’ safety and efficacy in conjunction with physical rehabilitation therapy as compared to physical therapy (PT) alone over a 12-week treatment period. Bioness acquired the PoNS system product line from original developer Solana Company (formerly known as Helius Medical Technologies) in April 2026. Prior to the transaction, for which financial terms were not publicly disclosed, PoNS held an FDA indication for multiple sclerosis (MS) treatment.&mThe 159-patient SRP met its primary endpoint, with statistically significant improvements on the Functional Gait Assessment (FGA) scale. Treatment with PoNS plus PT led to an adjusted mean change in FGA of 5.37 points at week 12, versus a non-clinically meaningful change of 3.31 points in the control group. Meanwhile, 45% more subjects treated with PoNS responded to treatment on the basis of a six-point FGA increase threshold, with at least 30% more on the basis of a ≥4-point or ≥5-point improvement threshold. Bioness’ CMO, Antonella Favit-Van Pelt, commented: “The totality of data in chronic stroke survivors with gait deficits confirms the broader evidence of PoNS therapeutic effect in improving walking disability by transitioning the outcome of physical therapy alone to a clinically meaningful effect with a 45.5% increased response rate to PoNS treatment as compared to PT alone.”

Neuromodulation is having a significant impact in the healthcare space for the treatment of conditions ranging from sleep apnoea and chronic migraine to major depressive disorder (MDD). According to GlobalData analysis, the global neuromodulation device market is projected to reach a valuation of over $13bn in 2035, up from around $6.8bn in 2025.

Transcutaneous spinal stimulation with upper extremity robotic training in chronic stroke and spinal cord injury: individual neurophysiological and clinical responses

 How close is your competent? doctor to using this? What is your doctor doing to prevent spasticity from interfering with this intervention?

Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation technique that delivers mild electrical currents through the skin to the spinal cord. It stimulates dormant nerve pathways to help restore voluntary movement, balance, and sensation, typically when paired with physical or occupational therapy.

Transcutaneous spinal stimulation with upper extremity robotic training in chronic stroke and spinal cord injury: individual neurophysiological and clinical responses

• Jeonghoon Oh,
• Michelle S. Scheffler,
• Shane T. King,
• Erin E. Mahan,
• Melissa Lee,
• Catherine Martin,
• Alexander G. Steele,
• Jony Sheynin,
• Jenny Dinh,
• Argyrios Stampas,
• Teresa Kaldis,
• Timea M. Hodics,
• Marcia K. O’Malley &
• Dimitry G. Sayenko 

We are providing an unedited version of this manuscript to give early access to its findings. Before final publication, the manuscript will undergo further editing. Please note there may be errors present which affect the content, and all legal disclaimers apply.

Abstract

Background

Damage to the corticospinal tract after stroke and spinal cord injury (SCI) often results in persistent upper extremity (UE) impairment. Transcutaneous spinal stimulation (TSS) and robotic technologies have been explored as approaches to facilitate motor training; however, their combined effects on UE sensorimotor recovery remain poorly understood. The purpose of this study was to examine the effects of TSS combined with UE robotic training in individuals with chronic stroke or SCI.

Methods

Five participants with stroke and six with SCI completed a 14-week, sham controlled, single blind crossover study consisting of four total weeks of assessments (one week each pre and post for both training phases), four weeks of UE training with sham TSS, a two-week washout period, and four weeks of UE training with active TSS. Each one-hour session (three days/week) included robotic exoskeleton-assisted UE movements and hand grip training, performed concurrently with sham or active TSS. Assessments included electrophysiological measurements and standardized rehabilitation outcomes.

Results

Descriptive analysis revealed meaningful individual improvements masked by group-level heterogeneity. In the stroke group, three participants showed grip strength improvement (assessed without stimulation) after the active phase (+ 9.4 Newtons [N] to + 23.9 N), with two-to-four-fold increases in forearm muscle activation. Mean Fugl-Meyer overall UE scores improved from 89 to 94.2. In the SCI group, two participants showed grip strength gains. One participant exhibited a six-fold immediate force increase (1.0 N to 6.2 N) during stimulation. Another participant achieved improved grip strength without stimulation (23.9 N to 36.8 N) and a three-fold increase in electromyography (EMG) activity from the flexor carpi radialis and first dorsal interosseous muscles, alongside partial pin-prick sensory recovery and self-reported restoration of previously affected perspiration during the active TSS phase.

Conclusions

Varied outcomes in participants confirm that therapeutic effects of combined TSS and robotic UE training are highly individualized. Three critical elements must be blended for the best outcomes of this combinatorial approach: residual UE function, a curated stimulation paradigm, and tailored UE training that provides appropriate challenge, intensity, and salience. The results suggest TSS with UE robotic training hold key potential when considered in the context of the physiological and functional profile of each participant.

Highlights

• Cervical TSS was applied during robotic upper extremity training in individuals with neurological impairment.

• A within-subject sham-controlled crossover design compared active and sham stimulation conditions.

• Neurophysiological responses and sensorimotor performance varied across individuals during stimulation.

• Improvements were most frequently observed during near motor-threshold stimulation combined with active task engagement.

Neuromodulation approaches and applications in the management of post-stroke pain: a comprehensive review

 

 So, this is what it is, does your incompetent? doctor have any recovery protocols on this?

Neuromodulation is a therapy that alters nerve activity by delivering electrical impulses or medications directly to the nervous system, essentially "reprogramming" abnormal nerve signals to treat conditions like chronic pain, Parkinson's, epilepsy, or bladder dysfunction, much like a pacemaker regulates heartbeats, using implanted devices or non-invasive methods. 

 Let's see how long your doctor has been incompetent! Over a decade and is still there? Massive incompetence of the board of directors in allowing it to fester for so long! Still no protocol on how to treat or prevent this pain!

• neuromodulation (27 posts to May 2015)
• post stroke pain (4 posts to August 2023)

Neuromodulation approaches and applications in the management of post-stroke pain: a comprehensive review

• 

  Stewart S. Cox 1

• M

  Marion Wood 1

• F

  Falon Sutton 1

• K

  Katherine Tucker 1

• N

  Nicole Cash 1

• R

  Ruxue Gong 1

• 

  Nathan C. Rowland 2,3

• 

  Steven A. Kautz 4,5,6

• 

• 

• 

  Xiaolong Peng 1*

• 1. Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States

• 2. Department of Neurosurgery, College of Medicine, Medical University of South Carolina, Charleston, SC, United States

Abstract

Introduction: 

Post-stroke pain (PSP) remains a common and profoundly debilitating consequence of stroke, both in terms of a delay in recovery and in substantially reducing quality of life. Both invasive and non-invasive brain stimulation techniques are increasingly being explored as possible treatment modalities for various forms of PSP. This literature review examines the current body of evidence for all forms of neurostimulation for PSP.

Methods: 

In this paper, we provide a review of the most recent literature exploring neuromodulation for PSP, covering several key domains: an examination of various PSP subtypes and the underlying mechanisms; a consolidation to date of the literature examining both invasive and non-invasive neuromodulation techniques for forms of PSP, and a discussion of future directions for the field.

Results: 

The impact of neuromodulation techniques on PSP populations, focusing primarily on spasticity and central post-stroke pain (CPSP) is discussed.

Conclusion: 

To varying degrees, numerous invasive and non-invasive modalities are beginning to be explored for individuals suffering from PSP. While preliminary, there is promising evidence to suggest that neuromodulatory techniques may reduce or ameliorate PSP. Further evidence and large clinical trials are needed to compare these treatments to the standard of care, as well as each other, to optimize outcomes for patients. In a rapidly evolving field, this review helps to provide the current state of neuromodulation in research on PSP.

Efficacy of non-invasive neuromodulation technologies in improving cognitive function and activities of daily living in patients with Alzheimer’s disease, Parkinson’s disease, and stroke: a systematic review and network meta-analysis

By not writing a protocol; YOU WERE COMPLETELY FUCKING USELESS! You're fired!
Efficacy of non-invasive neuromodulation technologies in improving cognitive function and activities of daily living in patients with Alzheimer’s disease, Parkinson’s disease, and stroke: a systematic review and network meta-analysis

• Chen Wang,
• Hui Chen,
• Min Liu,
• Wei Lu,
• Zhixiang Hao &
• Bingjie Wang 

We are providing an unedited version of this manuscript to give early access to its findings. Before final publication, the manuscript will undergo further editing. Please note there may be errors present which affect the content, and all legal disclaimers apply.

Abstract

Background

In recent years, non-invasive neuromodulation techniques (NINM) have demonstrated potential in promoting cognitive recovery. However, their relative efficacy across various disease contexts and stimulation protocols remains unclear.

Objective

To evaluate the efficacy and ranking of non-invasive neuromodulation techniques in improving cognitive function and activities of daily living (ADLs) among patients with Alzheimer’s Disease, Parkinson’s Disease, and Stroke, and to explore the impact of age on therapeutic outcomes in order to provide evidence-based guidance for personalized clinical interventions.

Methods

We conducted a systematic literature search of PubMed, Web of Science, the Cochrane Library, Scopus, and EMBASE databases without any language restrictions. The search was limited to the period from the inception of each database up to May 2025. Inclusion criteria were Randomized Controlled Trials (RCTs) involving patients (≥ 18 years) with patients with Alzheimer’s Disease, Parkinson’s Disease, and Stroke and cognitive impairment. Interventions included Repetitive Transcranial Magnetic Stimulation (rTMS), intermittent Theta Burst Stimulation (iTBS), Transcranial Direct Current Stimulation (tDCS), or sham. Outcomes included Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), Modified Barthel Index (MBI), and Instrumental Activities of Daily Living (IADL). Data extraction and risk of bias followed Cochrane guidelines. A Bayesian network meta-analysis was performed in R, with effects ranked by Surface Under the Cumulative Ranking curve (SUCRA).

Results

A total of 41 RCTs with 1957 participants were included. For cognitive outcomes, iTBS showed potential advantages on MoCA (MD = 3.62, 95% CI = 2.10 to 5.15; SUCRA = 95.1%) and MMSE (MD = 3.84, 95% CI = 1.96 to 5.71; SUCRA = 92.4%). Subgroup analyses revealed the strongest effects with stimulation of frontoparietal cognitive network. Age was identified as a factor influencing outcomes. For functional outcomes, low-frequency rTMS most improved MBI (MD = 13.43, 95% CI = 10.27 to 16.59; SUCRA = 85.8%), and tDCS had the greatest effect on IADL (SUCRA = 75.4%).

Conclusion

Non-invasive neuromodulation techniques improve cognitive function and ADLs in patients with Alzheimer’s Disease, Parkinson’s Disease, and Stroke(Well, where the fuck are they? Stored in your two functioning neurons?), with iTBS showing significant cognitive benefits. Due to research heterogeneity and methodological limitations, large-scale standardized RCTs are needed to optimize protocols(So, you completely failed at your job, expecting others to pick up your crapola?), explore age- and disease-specific effects, and enhance clinical translation.

Data availability

The datasets generated or analyzed during this study are available upon reasonable request from the corresponding author.

MUSC leads breakthrough in precision neuromodulation to transform brain recovery for millions

 So, this is what it is, does your incompetent? doctor have any recovery protocols on this?

 Let's see how long your doctor has been incompetent! Over a decade and is still there? Massive incompetence of the board of directors in allowing it to fester for so long!

neuromodulation (25 posts to May 2015)

Neuromodulation is a therapy that alters nerve activity by delivering electrical impulses or medications directly to the nervous system, essentially "reprogramming" abnormal nerve signals to treat conditions like chronic pain, Parkinson's, epilepsy, or bladder dysfunction, much like a pacemaker regulates heartbeats, using implanted devices or non-invasive methods. 

MUSC leads breakthrough in precision neuromodulation to transform brain recovery for millions

(BPT) - New precision neuromodulation techniques are redefining what's possible for neurological recovery, and the National Institutes of Health (NIH) has made a substantial investment to support the Medical University of South Carolina (MUSC) in leading a national effort. MUSC now stands at the forefront of groundbreaking research with the potential to transform recovery from stroke and neurological conditions.

More than 795,000 Americans experience a stroke every year. Millions more face other neurological injuries and diseases, including Parkinson's disease, traumatic brain injury and depression. For many, the hardest part begins afterward: trying to regain movement, speech and independence and return to a good quality of life. It's estimated that more than 13 million Americans are navigating recovery from these conditions — often while coping with lasting disabilities. For decades, research has focused on prevention or emergency treatment, not rebuilding lives in the months and years that follow.

Researchers at MUSC are changing that. Led by Steven Kautz, Ph.D., a Distinguished University Professor and the Christie Family Endowed Chair in Stroke Rehabilitation Research in the College of Health Professions, MUSC created the nation's very first precision neurorehabilitation center, where scientists pair personalized neuromodulation with rehabilitation to help the brain rewire itself — a neural-circuit based approach to rehabilitation.

This approach is so innovative that the NIH chose MUSC as a national leader, awarding the team a highly competitive P50 center grant in its rehabilitation infrastructure network — its flagship investment in rehabilitation research. MUSC's breakthrough research could transform how neurological patients recover across the U.S. and worldwide.

"The recognition of our work by NIH signals that precision neurorehabilitation is the future of neurologic recovery, and MUSC should lead that future," said Kautz. "We're dedicated to exploring the most effective technology to improve recovery for patients everywhere."

Internationally recognized in neurorehabilitation, Kautz and his team combine neuromodulation with rehabilitation to improve recovery for patients with stroke and other neurological conditions.

How neuromodulation works

Strokes alter a person's nervous system drastically, resulting in diminished function that can be very difficult to recover from, even with extensive rehabilitation therapy.

Using advanced precision neuromodulation technology, Kautz and the MUSC team are able to apply the latest imaging techniques to identify specific dysfunctional neural circuits. They then use advanced neuromodulation tools to stimulate those exact circuits during rehab, while patients perform activities guided by rehabilitation experts. This precise stimulation of neural circuits paired with rehab helps the brain to relearn skills and retrain faster, making therapy far more effective.

"While a patient can improve physical functioning to some degree by practicing activities in therapy, their results can be limited, and the process may be long and difficult," explained Kautz. "This groundbreaking technology helps the brain rewire itself, with processes that have rarely been applied to rehabilitation. These neuromodulation tools increase the excitability of a brain region while a patient performs the task so there's more neuroplasticity. Thanks to these precision techniques, and pairing neuromodulation so that the brain is in a more receptive state with rehabilitation, we can repair dysfunctional neural circuits so people will recover their physical functions better and faster. These results can bring real hope to people struggling to recover from stroke."

Real-world rehabilitation

This combination of rehab therapy with precision neuromodulation may also improve the durability of recovery for patients long after they leave rehabilitation. The program at MUSC explores many innovative ways to ensure skills improved in rehabilitation are lasting and applicable to real-world environments. The Clinical Research Center for Restoration of Neural-Based Function in the Real World (RENEW), also spearheaded by Kautz, is the first of its kind in the country to support people making this crucial transition from rehab to home.

Randal Davis, director of Strategic Research Initiatives at the MUSC College of Health Professions, experienced a neurological condition that provided valuable insights.

"I was diagnosed with Guillain-Barré syndrome at 36 and had to learn to walk again," said Davis. "I thought I was doing great in rehab. I could roll my wheelchair under the sink. I was rolling across the terrazzo floor and learned all these tips and tricks. Then I got home; I'm rolling the wheelchair across carpet and have a pedestal sink with nowhere to put my toothbrush. Suddenly, all those things learned in rehab weren't durable."

This situation happens far too frequently, Kautz explained. "Recovery shouldn't end when patients leave the rehab clinic. Too often, gains made in therapy don't translate to real life. MUSC is solving that gap. We've designed labs where we'll use virtual reality to mimic the real world more closely."

Precision neuromodulation as the future of neurologic recovery

Kautz is leading the only precision neurorehabilitation center in the country, and these techniques are already being used or explored for stroke recovery and other neurological conditions.

"These neuromodulation tools are crucial to helping us understand neural circuits, then use that information to tailor precision treatment to each individual. This will help us achieve the maximum functional benefits of therapy for each patient," said Kautz. "And these tools could benefit any condition where neural circuits aren't functioning the way they need to, opening the door for better recovery and helping people improve their physical and mental health, ultimately improving their quality of life."

Trailblazing research

The NIH has recently awarded an additional grant of $7.8 million to complete the RENEW Center, looking to MUSC as a role model for the country.

With this award, NIH has entrusted MUSC with shaping what comes next — not only advancing precision neurorehabilitation but training the researchers who will define the field for decades. The work done here is meant to open pathways, creating a national network of scientists equipped to deliver precision recovery to patients everywhere.

"This level of NIH support validates a decade of groundbreaking work," said Kautz. "These investments show that precision neuromodulation isn't a theory anymore; it's a national priority. Our goal is to develop new knowledge and tools for the research and clinical community so we can bring these innovations into the clinic quickly, so neurological patients everywhere can benefit from the science unfolding at MUSC in real time. This has the potential to be truly life-changing."

Learn more about this innovative research at CHP.MUSC.edu/research-innovation/centers/stroke-recovery.