Latest news with #DeborahBackus
Medscape
4 days ago
- Health
- Medscape
Home-Based Exercise as Effective as In-Clinic Care for MS
PHOENIX — In the first randomized phase 3 trial to compare a home-based and facility-based supervised exercise program in patients with multiple sclerosis (MS), outcomes were equivalent at both 16 and 52 weeks. These findings now support home-based exercise as an evidence-based option for patients who prefer to work out at home. Evidence of equivalence from a controlled trial is useful because 'home-based exercise programs might improve both access and adherence for at least some patients,' said study investigator Deborah Backus, PT, PhD, vice president for research and innovation at the Shepherd Center, Atlanta, Georgia. The findings were presented May 29 at the Consortium of Multiple Sclerosis Centers (CMSC) 2025 Annual Meeting. First Phase 3 MS Exercise Trial Conducted at eight participating US centers, the STEP trial was limited to patients with modest walking impairment. An Expanded Disability Status Scale (EDSS) score of 4.5 to 6.0 was among the entry criteria designed to select a population that was still ambulatory but with a need for intervention to preserve function. 'We wanted patients who can walk with some measured and perceived limitations but who were still able to exercise safely,' said Backus. The similar facility- and home-based regimens were based on Guidelines for Exercise in MS (GEMS). In one segment of the trial, 189 patients were randomized to the facility-based (GEMS-F) or the home-based (GEMS-H) programs. In the second segment of the trial, 190 patients were permitted to select their program, creating choice GEMS-F and choice GEMS-H groups that were compared with each other and with the randomized groups. The primary outcome was the timed 25-foot walk test (T25FW). Other outcomes included the 6-minute walk test (6MWT), change in EDSS, and scores on the 12-item MS walking scale (MSWS-12). All outcomes were evaluated at 16 weeks and again at 52 weeks after the exercise programs were initiated. Expressed in least-squares means adjusted for age, sex, and baseline EDSS, the improvement from baseline in T25FW was significant for all study groups and was similar between the GEMS-F and GEMS-H groups, in comparisons within and between the randomized and choice patient populations. Also consistent across all four study groups, a substantial proportion of the improvement was lost between weeks 16 and 52, even if at least a numerical and, in some cases, a statistical advantage was maintained relative to baseline. The 6MWT and MSWS-12 outcomes showed a similar pattern with a substantial improvement at 16 weeks that eroded over subsequent follow-up. Again, there was a numerical advantage at 52 weeks over baseline in all of the groups even if it did not reach significance in every arm. The mean group EDSS scores, which were relatively preserved from baseline to week 16 declined from that timepoint to week 52 in all study groups. There were modest differences in baseline characteristics among the four study groups, but the impact of the COVID pandemic was a major limitation of the study, said Backus. Dropouts by 52 weeks were substantial throughout the study population but were greater among those in the GEMS-H group, who were less likely to return to the facility for assessments. Although exercise regimens in terms of aerobics and resistant training were the same for all groups, Backus acknowledged that there were some differences in access to equipment. For example, participants in the GEMS-F group performed aerobic training on treadmills that were not necessarily available to all of those in the GEMS-H group, even if other forms of aerobic exercise were substituted. Overall, Backus said that exercise intensity and other key aspects, such as coaching, were similar in the GEMS-F and GEMS-H groups. Evidence Base for At-Home Exercise Commenting on the findings, Robert W. Motl, PhD, professor of kinesiology, nutrition, and rehabilitation, University of Illinois, Chicago. and a co-chair of the session where the study was presented, noted that regardless of whether patients completed the exercise program at home or in a facility, all of them were provided with resources for fall prevention, and the lack of serious adverse events in any arm is an important finding from this study. 'With no safety differences and a comparable effect, the results provide an evidence basis for exercising at home, which is more convenient for patients and more cost-effective,' Motl said. Another expert in rehabilitation for patients with MS, Frederick W. Foley, PhD, assistant professor in the Department of Neurology, Albert Einstein School of Medicine, Bronx, New York, agreed that the research provides support for home-based exercise in MS patients. 'There is a need to reduce the dependence of MS patients on care within a hospital or outpatient facility,' said Foley, who was not involved in the trial. 'It is not only less convenient and potentially more costly to receive care in a facility, but patients are also generally more comfortable in their own home,' he said. The loss of benefit from week 16 to week 52, although expected and consistent with other lifestyle interventions, was disappointing. He pointed out that sustained benefit from exercise is elusive regardless of setting. 'The difficulty of achieving long-term benefit from behavioral interventions is pretty well recognized,' Foley said. He called this the 'biggest challenge' for extending an exercise treatment effect.
Yahoo
20-05-2025
- Health
- Yahoo
Helius to Spotlight Study Confirming Improved Long-Term Outcomes from Adherence to PoNS Therapy® at CMSC Annual Meeting
Shepherd Center's Dr. Deborah Backus to Showcase Final Results of PoNSTEP Study, Providing New Insight into Maximizing Impact of Neuromodulation to Improve Gait in People with MS NEWTOWN, Pa., May 20, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ: HSDT), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, announced it will highlight the results of a new study confirming the therapeutic regimen and sustained efficacy of its Portable Neuromodulation Stimulator (PoNS®) device for people with multiple sclerosis (MS) at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting. The event runs from May 28-31 at the Phoenix Convention Center in Phoenix. Deborah Backus, PT, Ph.D., FACRM – Vice President of Research and Innovation at Atlanta's Shepherd Center, one of six sites that conducted the PoNS Therapeutic Experience Program (PoNSTEP) study – will present the full study results for the first time at a platform presentation session on Thursday, May 29, from 3:20-3:40 p.m. Attendees can learn more about PoNSTEP from Helius Chief Medical Officer Antonella Favit-Van Pelt, M.D., Ph.D., who will meet attendees at booth 600 to answer questions and discuss the study outcomes in more detail. 'Those of us familiar with PoNS have seen how it enables some people with MS to walk better. But PoNSTEP data provide the first clinical evidence that there's a statistically significant relationship between adherence to PoNS Therapy and the degree of improvement – and that the improvement can be sustained,' Dr. Backus said. 'These results affirm the potential of PoNS Therapy to drive real, measurable gain in better mobility for people with MS. For a population that has long faced limited treatment options for gait deficits, this represents an important step forward.' PoNSTEP was a three-phase, real-world therapeutic experience study designed to assess the impact of adherence on gait deficit and long-term outcomes. Participants began with two weeks of supervised in-clinic therapy, followed by 12 weeks of combined clinic and at-home use, and concluded with a six-month follow-up period to evaluate the durability of their improvements. PoNSTEP's key finding is that stronger adherence to PoNS Therapyä, which combines non-invasive cranial nerve translingual neuro-stimulation (TLNS) with specific physical exercises, results in better therapeutic outcomes. The most-adherent participants maintained superior gait improvement from the end of the study's supervised therapy phase through its unsupervised therapy phase, achieving a gain of over 6 points in their Dynamic Gait Index (DGI) scores – a key clinical measurement of walking function and balance – over the first 14 weeks of the trial. PoNSTEP data also show gait improvement levels are durable, sustained at 6 months post-treatment. Highly adherent patients—using the device for at least 85% of the recommended 100–120 minutes per day during Phase 2—improved their Dynamic Gait Index (DGI) scores by more than 6 points. Those with moderate adherence (around 70%) showed a smaller, yet meaningful, improvement of 5 points total. These results demonstrate a linear relationship between adherence and gait improvement outcomes. In addition, more than 95% of participants who were evaluated 6 months later maintained their level of improvement. 'PoNSTEP is the latest in a series of important milestones for PoNS and I'm delighted to join Dr. Backus in sharing PoNSTEP full study results with the broader MS community,' said Dr. Favit-Van Pelt. The study provides further evidence of the power of neuromodulation and neuroplasticity in rehabilitating the neural network and confirms the benefit of 14 weeks of PoNS therapy as a meaningful therapeutic option for people with MS and gait deficit. Access to PoNS therapy is provided by insurance through the U.S. Department of Veterans Affairs and U.S. Department of Defense, with several commercial healthcare providers already starting to reimburse the device out of network. About PoNS Therapeutic Experience Program (PoNSTEP) The Therapeutic Experience Program ('TEP') is a Helius-sponsored, open-label, observational, interventional multi-center outcome research study designed to assess adherence to on-label PoNS therapy for improvement in gait deficits for patients with multiple sclerosis ('MS') in a real-world clinical setting. The study aims to understand better the relationship between adherence to on label (100-120 minute per day) PoNS Therapy, which combines the PoNS device with physical therapy, and the therapeutic outcome on gait deficit improvement over 14 weeks of study treatment, as measured by changes in the Dynamic Gait Index (DGI) scores. PoNS therapy is applied in a supervised clinical setting for the first two weeks (Phase 1) and, independently, at home for the remaining 12 weeks (Phase 2). The study also includes a six-month no-treatment follow-up phase aimed at establishing the durability of the therapeutic effect (Phase 3). The primary endpoint of the study is maintenance of gait improvement from the end of supervised therapy (Phase 1) to the end of unsupervised therapy (Phase 2) in relation to the subject's adherence to PoNS therapy. The secondary endpoints are, among others, maintenance of improvement of gait and balance deficit over a 6-month timeframe and clinical global impression of change. The study was performed at six Centers of Excellence across the United States, including Neurology Center of New England in Foxboro (MA), the Shepherd Center in Atlanta (GA), Montefiore Medical Center ('Montefiore') in NY (NY), Oregon Health & Science University ('OHSU') in Portland (OR), MGH Institute of Health Professions in Boston (MA), NYU Langone Health in NY (NY), and recruited 43 MS participants with gait deficit. About the PoNS Device and PoNS Therapy The Portable Neuromodulation Stimulator ('PoNS') is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller and it's used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from MS and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications: (i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury ('mmTBI') and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. For more information visit About Helius Medical Technologies, Inc. Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using orally applied technology platform that amplifies the brain's ability to engage physiologic compensatory mechanisms and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. The Company's first commercial product is the Portable Neuromodulation Stimulator. For more information about the PoNS® or Helius Medical Technologies, visit Cautionary Disclaimer Statement Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as 'believe,' 'expect,' 'continue,' 'will,' 'goal,' 'aim' and similar expressions. Such forward-looking statements include, among others, statements regarding future presentation and uses of the PoNSTEP study results and the uses and effectiveness of PoNS and PoNS Therapy. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company's expectations include uncertainties associated with the Company's capital requirements to achieve its business objectives, availability of funds, the Company's ability to find additional sources of funding, manufacturing, labor shortage and supply chain risks, including risks related to manufacturing delays, the Company's ability to obtain national Medicare insurance coverage and to obtain a reimbursement code, the Company's ability to continue to build internal commercial infrastructure, secure state distribution licenses, market awareness of the PoNS device, future clinical trials and the clinical development process, the product development process and the FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the 'Risk Factors' section of the Company's Annual Report on Form 10-K for the year ended December 31, 2023, and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at or The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law. Investor Relations Contact Philip Trip Taylor Gilmartin Groupinvestorrelations@
