Thursday, July 9, 2026
FDA Clears PoNS Device for Stroke Rehabilitation, Expanding Neurostimulation Beyond MS Indication
Your competent? doctor and hospital want to get survivors recovered, so they already were following this and have plans to bring it in, right? NO? Know nothing and doing nothing?
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 PoNS Device for Stroke Rehabilitation, Expanding Neurostimulation Beyond MS Indication
Author(s)Marco Meglio
Fact checked by: Kelly Kinges
Key Takeaways
- Clearance expands prior multiple sclerosis indication and represents the first noninvasive, orally applied neuromodulation device authorized in the US for stroke rehabilitation.
- Pooled pivotal analyses showed adjusted mean FGA change 5.37 with active stimulation plus PT vs 3.31 with sham plus PT, meeting Hochberg multiplicity. The 510(k) clearance was supported by a 3-study, 159-patient registrational program showing a 45.5% increase in response rate vs physical therapy alone, and includes Medicare coverage at launch.>
Antonella Favit-Van Pelt, MD, PhD
Bioness Medical, Inc, announced FDA 510(k) clearance of the PoNS (Portable Neuromodulation Stimulator) System for the treatment of dynamic gait deficit due to chronic stroke symptoms, making it the first noninvasive, orally applied neuromodulation device cleared for stroke rehabilitation in the United States. The clearance expands PoNS beyond its existing FDA-cleared indication in multiple sclerosis (MS) and positions the home-use device as a prescription adjunct to supervised physical therapy for the more than 7 million Americans living with stroke-related gait disability.1
The clearance is supported by the Stroke Registrational Program (SRP), a 3-study, 159-patient program conducted across 10 centers of excellence in the US and Canada. In July 2025, then-manufacturer Helius Medical Technologies announced positive SRP outcomes and planned FDA submission under the device’s breakthrough device designation, setting the stage for the clearance now granted under Bioness, which acquired the PoNS program from Helius.2
The PoNS device delivers mild electrical neurostimulation through a mouthpiece placed on the tongue, activating branches of the trigeminal and facial cranial nerves. These cranial nerves connect directly to the brain stem, and the stimulation is designed to promote neuroplasticity, facilitating the development of new neural networks to compensate for corticospinal pathway damage sustained during stroke. The device is used by the patient at home in conjunction with a physical rehabilitation exercise program prescribed by a physician.
READ MORE:
In the pooled primary analysis of the SRP pivotal studies, active PoNS plus physical therapy produced a statistically significant adjusted mean change in Functional Gait Assessment (FGA) of 5.37 points (95% CI, 4.23-6.52) at week 12, compared with 3.31 points (95% CI, 1.96-4.76) in the sham PoNS plus physical therapy control group. The propensity-adjusted between-group difference was 2.06 points (95% CI, 0.29-3.84; P = .0233), meeting the Hochberg multiplicity requirement. Using a 6-point FGA increase threshold, 56.1% of active PoNS participants were classified as responders vs 11.1% of controls, a 45% increase in response rate.¹ Durability of effect was demonstrated through week 24, with a mean FGA reduction of less than 5% from the week 12 peak and 89.7% (95% CI, 81.8%-97.5%) of participants meeting the prespecified durability performance goal.1
Balance improvement on the Berg Balance Scale (BBS) trended in favor of active PoNS but did not reach statistical significance in the between-group comparison. Risk of falling was resolved in 17.4% of active PoNS participants vs 8.9% of controls, also without statistical significance. No treatment-related serious adverse events were reported across the SRP trials, and adverse event rates ranged from 0% to 14.8%, with none attributable to the device.
“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 (physical therapy) alone,” Antonella Favit-Van Pelt, MD, PhD, chief medical officer of Bioness, said in a statement.
The stroke clearance builds on a well-established regulatory and payer trajectory for PoNS in MS. The device received FDA de novo marketing authorization for MS-related gait deficit in 2021, and major commercial payers including UnitedHealthcare, Anthem, and Aetna have since authorized claims for the device in MS patients.3 Under the new stroke indication, Bioness has noted that Medicare coverage is available at launch, a meaningful access advantage given the predominantly older demographic of stroke survivors.¹
Bioness plans to begin making PoNS commercially available for stroke in Germany first, in close collaboration with MS specialists and rehabilitation physicians, accompanied by a required Risk Management Program and Patient Support Program.
Wednesday, July 8, 2026
World Stroke Organization (WSO) rehabilitation certification program
Useless! Where is the RECOVERY CERTIFICATION that survivors want? Since you're not doing anything survivors want, just turn it over to survivors so recovery protocols can be created!
World Stroke Organization (WSO) rehabilitation certification program
Abstract
Background:
Rehabilitation(NOT RECOVERY! That is how fucking incompetent the WSO is!) has been identified by the World Stroke Organization (WSO) as a key priority to reduce the global burden of stroke. Global access to rehabilitation('Access is useless if you don't have recovery protocols! Or are you OK with your tyranny of low expectations? Survivors aren't!) is inconsistent and is particularly limited in low-and-middle-income countries. Progress in rehabilitation has not been as well evidenced as progress in acute care(NOT RECOVERY!). The WSO certification program, which commenced in 2021, focuses on acute interventions. A rehabilitation certification program, applicable in both inpatient and outpatient rehabilitation settings, has been developed to complement the acute certification program to address global implementation of evidence-based stroke care(NOT RECOVERY!).
Aim:
To develop globally applicable, evidence-based, stroke rehabilitation recommendations and performance metrics for use in a stroke rehabilitation certification program.
Methods:
Strong recommendations were extracted from high-quality stroke rehabilitation Clinical Practice Guidelines, systematic reviews and syntheses of clinical practice guidelines, and from the defining criteria of the International Stroke Recovery and Rehabilitation Alliance (ISRRA) Centers of Clinical Excellence. The WSO Rehabilitation Implementation Committee led the development of the recommendations and invited input from three international, multidisciplinary consultation groups. Group 1 compared strong recommendations from the Australia/New Zealand Living Guidelines with other international guidelines to identify consistent, high-quality recommendations. Group 2 mapped recommendations from global guideline syntheses against the Australia/New Zealand Living Guidelines. Group 3 reviewed and adapted the ISRRA Center of Clinical Excellence recommendations. Recommendations were consolidated through consensus meetings involving representatives from each workgroup, including people from high, upper-middle, and lower-middle-income countries. Strong recommendations that were consistent across teams, alongside additional recommendations based on certainty of evidence, anticipated risk versus benefit, and relevance across settings, were included as patient-level recommendations in the implementation certification program. Service-level recommendations were generated through consensus or derived from existing guidelines. An implementation manual, outlining “what,” “who,” and “how,” as well as indicators to demonstrate performance of each recommendation, was developed to support clinical implementation and to facilitate assessment for certification. The criteria were piloted between November 2024 and September 2025 at 15 centers in six upper- and lower-middle-income countries (three continents) and subsequently refined. Expectations (mandatory or recommended) for each level of certification (Minimal, Essential and Advanced) were set post-pilot through rating strength of evidence, a series of group discussions and review of pilot data.
Results
Fifty-five recommendations were included. Nine recommendations address service-level indicators, and 46 address patient-level indicators. Service-level indicators address defining features of rehabilitation services that are not apparent in individual patient medical record audits. Patient-level indicators address management of swallowing impairment, nutrition and hydration, information provision and goal setting, amount and timing of rehabilitation, exercise and motor rehabilitation, visual function, communication, mood and cognition, management of complications, and discharge planning and support. An implementation manual complements the recommendations to guide clinical care(NOT RECOVERY!) and consistent assessment.
Conclusions
The WSO rehabilitation recommendations and performance metrics incorporate the most current evidence and have been refined following pilot-testing. The recommendations are globally relevant and support both resource-limited and high-income settings in participating in the rehabilitation certification program to advance international stroke rehabilitation delivery.
Blood-activating, depression-relieving formula alleviates post-stroke depression: mechanistic insights from network pharmacology and microglial validation
You're so fucking incompetent you need to treat depression rather than having EXACT RECOVERY PROTOCOLS so that depression treatment isn't needed! I'd suggest taking up basket weaving; more in line with your IQ.
Blood-activating, depression-relieving formula alleviates post-stroke depression: mechanistic insights from network pharmacology and microglial validation
Abstract
Introduction:
Post-stroke depression (PSD) is common and disabling, yet mechanism-based, multi-target therapies that jointly curb neuroinflammation and support cell survival are scarce. We evaluated a Blood-Activating, Depression-Relieving (BADR) herbal formula for effects on PSD-relevant molecular hubs and microglial phenotypes.
Methods:
BADR constituents from Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform were standardised and mapped to human protein targets. Target-disease interaction networks were assembled in Search Tool for the Retrieval of Interacting Genes/Proteins, clustered with Molecular Complex Detection, and functionally annotated via Kyoto Encyclopedia of Genes and Genomes Orthology-Based Annotation System (KEGG/GO). For experimental validation, BV2 microglia were activated with lipopolysaccharide (LPS; 24 h) and co-treated with BADR within a pre-established non-cytotoxic range; dexamethasone (1 μM) served as comparator. Outcomes included cytokines (IL-1β, TNF-α, IL-6; enzyme-linked immunosorbent assay), expression of selected nodes (EGFR, STAT3, JUN, PIK3CA, BCL2; quantitative real-time polymerase chain reaction/western blot), viability (Cell Counting Kit-8), and apoptosis (flow cytometry).
Results:
Network analysis highlighted two dense modules enriched for PI3K-AKT, JAK–STAT, and neuroactive-ligand signaling. Hubs included EGFR, AKT1, STAT3, JUN, PIK3CA, and BCL2, with EGFR, STAT3, PIK3CA, JUN, and BCL2 prioritised for cellular validation based on topology, pathway relevance, and compound-target connectivity. In BV2 cells, BADR attenuated LPS-induced IL-1β, TNF-α, and IL-6 surges, improved viability, and reduced total apoptosis, with directionally comparable effects to dexamethasone. Mechanistically, BADR down-regulated EGFR/JUN/STAT3/PIK3CA and restored BCL2 at transcript and protein levels.
Conclusion:
By converging network-level predictions with microglial phenotyping, the formula exerts coordinated anti-inflammatory and pro-survival effects centred on the EGFR-STAT3-PI3K nodes in a PSD-relevant context. These data provide a mechanistic rationale for further phosphorylation-level and in vivo validation toward multi-target PSD therapeutics.
More at link.
Queen’s North Hawaii launches stroke support group
Complete admission THAT YOU ARE A MASSIVE FUCKING FAILURE AT 100% RECOVERY FOR SURVIVORS! Will your incompetent board of directors at least reconstitute the hospital with the correct objective? 100% recovery for all is the only goal in stroke!
Queen’s North Hawaii launches stroke support group
HAWAII ISLAND (HawaiiNewsNow) - Queen’s North Hawaii Community Hospital is launching a new support group for stroke survivors and their caregivers.
The free group will meet every other month and offer education, open discussions, practical recovery tools and guest speakers to help participants navigate life after a stroke.
Hospital officials said the first meeting is scheduled for Tuesday, July 21, from 5 p.m. to 6 p.m. in the Mauna Kea-Mauna Loa conference room at Queen’s North Hawaiʻi Community Hospital.
The sessions will be led by speech-language pathologist Amy Shipley of the hospital’s Rehabilitation Services Department.
“The stroke support group is all about supporting the families and people who are in recovery from stroke,” Shipley said. “Having an informal meeting where people can discuss the triumphs and hardships and nuances of recovery is really important.”
The support group is free and open to the public, and no registration is required.
For questions, contact ashipley@queens.org or call 808-881-4814.
Effect of Scapular and Pelvic Patterns of Proprioceptive Neuromuscular Facilitation on Functional Mobility in Stroke Survivors
In the 15 years PNF has been suggested for stroke, there has been A MASSIVE FAILURE IN CREATING PROTOCOLS ON THIS! Whom do we contact to get this corrected? Hope their experience with stroke after they become the 1 in 4 per WHO that has a stroke! is appropriate comeuppance for their current failures to solve stroke!
- PNF
(13 posts to April 2011)
Effect of Scapular and Pelvic Patterns of Proprioceptive Neuromuscular Facilitation on Functional Mobility in Stroke Survivors
Cite this article as: Jadhav D B, Kanase S (July 07, 2026) Effect of Scapular and Pelvic Patterns of Proprioceptive Neuromuscular Facilitation on Functional Mobility in Stroke Survivors. Cureus 18(7): e112225. doi:10.7759/cureus.112225
Abstract
Introduction:
Stroke is a leading cause of adult disability worldwide, resulting in significant motor, sensory, and cognitive impairments that hinder independence and quality of life. Among the most debilitating consequences are impaired balance and an increased risk of falls, which contribute to reduced participation in daily activities, diminished self-confidence, and greater dependency. Hemiplegic gait patterns, postural instability, and impaired weight shifting are common, limiting functional recovery. Proprioceptive neuromuscular facilitation (PNF), a rehabilitation technique aimed at enhancing neuromuscular control, joint mobility, and muscle strength, is widely used in stroke recovery.
Objective:
To evaluate the effect of scapular and pelvic patterns of PNF on functional mobility in stroke survivors.
Methods:
This was a quasi-experimental study conducted over six months in Karad. A total of 30 stroke patients were selected based on specific inclusion and exclusion criteria. Informed consent was obtained from all participants prior to enrollment. Group A received scapular and pelvic PNF along with conventional physiotherapy, while Group B received only conventional physiotherapy. The intervention was administered for six weeks, and outcome measures included Barthel Index (BI) and Stroke Impact Scale (SIS). Pre- and post-intervention assessments were performed to evaluate functional mobility.
Results:
Significant improvements were observed in both groups following treatment; however, Group A demonstrated greater improvement compared to Group B. Among the 30 stroke survivors, functional mobility and independence improved following intervention: in Group A (scapular-pelvic PNF), BI scores increased from 55.2 ± 8.4 to 75.6 ± 7.5, with a mean difference of 20.4 and a p-value of <0.0001, while Group B (control) improved from 56.0 ± 7.9 to 66.8 ± 8.1, showing a mean difference of 10.8 and a p-value of 0.0002. SIS scores showed similar trends: Group A increased from 52.4 ± 9.1 to 73.8 ± 8.2 (mean difference 21.4) with a p-value of <0.0001, and Group B from 53.1 ± 8.5 to 65.6 ± 9.0 (mean difference 12.5) with a p-value of 0.0003.
Conclusion:
Stroke survivors who received scapular-pelvic PNF demonstrated significant improvements in functional mobility and independence, while the control group showed moderate gains. These findings suggest a potential benefit of targeted PNF intervention in enhancing post-stroke recovery and provide preliminary evidence supporting further investigation.
More at link.
Towards routine biomechanical data collection in stroke rehabilitation: a usability comparison of IMU and markerless motion capture systems for functional upper-limb assessments
'Assessments' DO NOTHING FOR RECOVERY! With no protocols based on the assessment; THIS WAS COMPLETELY FUCKING USELEESS! You're all fired! You, your mentors and senior researchers are obviously clueless on how to get survivors recovered! I'd suggest basket weaving for your mental capacity.
Towards routine biomechanical data collection in stroke rehabilitation: a usability comparison of IMU and markerless motion capture systems for functional upper-limb assessments
Abstract
Objective measurement of upper-limb movement quality based on biomechanical data collected in clinical routine has the potential to enable precision neurorehabilitation at scale. However, integrating biomechanical data collection into daily clinical workflows remains challenging. In this exploratory study, we evaluated the usability of two technologies for routine kinematic data collection: an IMU-based version of the instrumented Action Research Arm Test (iARAT-IMU) and a MMC markerless motion capture (MMC) system. First, five physiotherapists independently operated the iARAT-IMU across seven clinical routine assessment sessions at a rehabilitation clinic in Switzerland to quantify learning curves, setup times, and usability. Second, we conducted a preference study in which the same therapists used both, the IMU- and MMC-system, during a standardized drinking task and completed quantitative and qualitative usability assessments focusing on system preference and underlying reasons. Results show that therapists rapidly learned to operate the tablet application for scoring the iARAT; however, the IMU system added approximately 11 min of setup time and sometimes required assistance. In contrast, the MMC workflow required approximately 2 min of additional time - well within the 5-minute maximum indicated a priori by therapists as acceptable for clinical routine and received consistently higher usability ratings. Most therapists preferred this approach due to greater efficiency and reduced patient burden. These findings highlight important design considerations for future digital assessment tools and indicate that MMC systems may offer a more feasible pathway toward routine biomechanical data collection for upper-limb assessments in clinical neurorehabilitation.
Post Stroke Management: Optimizing Care after the Acute Phase - Luke Bradbury, MD
There couldn't be more useless words in stroke than 'management' and 'care'! A hell of a lot of people in stroke need to be fired, starting with this MD!
Post Stroke Management: Optimizing Care after the Acute Phase - Luke Bradbury, MD
Intended Audience
This activity is designed for nurses, physicians (including EM, hospitalists, primary care, and neurology), neurosurgeons, and stroke coordinators.
Learning Objectives
As a result of participation in this educational activity, members of the healthcare team will be able to:
- Discuss guidelines and common pitfalls for post-stroke blood pressure management in the subacute and chronic phases of care
- Explain the various strategies for antiplatelet and anticoagulation treatment for different stroke subtypes
- Identify which patients are most appropriate to refer to cardiology for consideration of PFO closure
- Describe how the latest studies and guidelines inform the management of symptomatic and asymptomatic carotid artery stenosis
- NOTHING ON HOW TO GET SURVIVORS RECOVERED! Or don't you ever think what survivors want?
A tool to help keep dementia in check
Pretty much useless guidelines! ABSOLUTELY NOTHING SPECIFIC!
A tool to help keep dementia in check
If you worry about your risk of dementia, Lauren Sprague knows your fear. Her father had a stroke when she was in high school. What followed was a long, slow descent into memory loss and dementia. He died at just 63.
"So, since I was 16 years old, pretty much every day of my life I worry, 'Is today the day that the same thing could happen to me that happened to my dad?'" Sprague said. "It's an incredible fear to walk around with.
Every day of my children's lives up until now, I've worried that that could be me," she said.
Then she went to see Dr. Jonathan Rosand, who told us, "Time and again I would get the question, 'Doctor, what can I do to take good care of my brain so that I don't end up like my mother, my brother, my father?'"
Rosand is a neurologist at Massachusetts General Hospital in Boston. He explained to Sprague it was possible to cut the risk of dementia by making changes to daily habits, from choices about what you eat, to the amount of physical activity you get every day. "It turns out that these modifiable risk factors probably account for at least 40% of all dementia cases," Rostand said.
A committee of experts from around the globe has concluded that about 40 to 45% of dementia cases could be prevented or delayed by addressing 14 modifiable risk factors:
- Physical inactivity
- Smoking
- Excessive alcohol consumption
- Air pollution
- Traumatic brain injury
- Hearing loss
- Untreated vision loss
- High blood pressure
- Diabetes
- Obesity
- Low education attainment
- Social isolation
- High cholesterol
- Depression
Rostand said that it's a very common conception that if dementia or Alzheimer's is in one's family, that they are doomed. "But the truth is there's so much we can do," he said.
The idea that exercise and diet are important is not new, of course. But what is new is a tool from Rosand and his team to help you understand exactly how much and what kind of lifestyle changes are beneficial. It starts with a simple questionnaire free to everyone online, called the Brain Care Score.
"The Brain Care Score is a tool for any of us to use in our daily lives that lists out the modifiable risk factors for dementia, stroke and depression," Rostand said.
The Brain Care Score allows you to identify traits and lifestyle habits that can impact your brain health. / Credit: Global Brain Coalition
The healthier your habits, the higher your score. And to improve your score, you pick which habits you want to focus on changing. Rostand said, "It's a guide to where you can go next. And in our work with patients, it really does give a choice, and a sense of freedom."
A groundbreaking study from June 2025 found that a five-point higher Brain Care Score is associated with a 43% lower risk of developing heart disease, and a 31% lower incidence of most common cancers (including lung, colorectal, and breast cancer).
It's evidence that what's good for the brain is good for the rest of the body, too.
So, where to start? For Lauren Sprague and her husband, Scott, change started in the kitchen. They doubled down on greens and cut out highly-processed foods. (This added one point to her score.) They spend more time outdoors, which helps with fitness and stress relief. (That can add 2 more points.) She also takes time to sing and create, adding meaning, more stress relief, and purpose (while adding 2 more points).
Sprague said, "The Brain Care Score really gave me the prescription that I needed. And the wonderful thing about it is, it is a recommendation, but there is nuance, and it can be customized, which is wonderful."
And Rosand is hoping this is one prescription that we all can share. He said, "The key message we want to convey with the Brain Care Score is, it is you. It is each of our viewers. It is everyone who wants to take a step forward. It's up to you and you're in control."
For more info:
- Take the Brain Care Score (Global Brain Care Coalition)
- Understanding your Brain Care Score
- Dr. Jonathan Rosand, McCance Center for Brain Health at Massachusetts General Hospital
- Lauren Sprague
Story produced by Amol Mhatre. Editor: Emanuele Secci.
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