The PoNS Therapeutic Experience Program, which utilises an innovative device on the tongue, has shown significant improvements for gait rehabilitation in people with Multiple Sclerosis. Researchers say the results mark an important step forward in understanding the role of neuromodulation and neuroplasticity in gait function.

PoNS therapy – short for Portable Neuromodulation Stimulator – uses translingual stimulation of cranial nerves to induce neuromodulation and neuroplasticity, improving gait and balance in patients with neurological conditions like MS, Traumatic Brain Injury (TBI), and stroke.

The PoNSTEP clinical trial in MS patients showed significant improvements in gait rehabilitation, with patients adhering to 70 to 85 per cent of the recommended therapy.

According to neurotech company Helius Medical Technologies, which has developed the therapy, the mechanism of the therapy involves activating specific brain areas responsible for cognitive control of movement and coordination.

Through clinical data and real-world utilisation of the therapy, PoNS has demonstrated durability of effect, which Helius says evidences its long-term therapeutic benefits.

Neuro Rehab Times speaks to Helius’ chief medical officer, Dr. Antonella Favit-VanPelt, to find out more.

How does it work?

PoNS therapy induces neuromodulation by stimulating fibres on the superficial part of the tongue. However, when combined with functional activity it can help compensate for impairments in the brain’s vestibular system, Favit-Van Pelt explains.

The vestibular area plays a crucial role in postural control, balance, and gait, communicating with multiple brain regions that regulate these functions.

“PoNS therapy effectively redirects information from the vestibular area through the trigeminal pathway, engaging key cortical regions such as the dorsolateral prefrontal cortex, the right anterior cingulate cortex, and the motor cortex,” says Favit-Van Pelt.

“By stimulating these areas, the therapy can counteract impairments caused by demyelination in MS, neural disruption from TBI or deficits resulting from stroke – all conditions we have studied.

“When translingual stimulation is combined with physical exercise, the brain receives compensatory neuromodulation signals, activating pathways that transmit signals via the corticospinal tract to the muscles.

“In conditions such as MS, this pathway is often impaired due to demyelination, which disrupts the nerve’s ability to conduct signals at the appropriate speed. Similar impairments occur in TBI, stroke, and other neurological conditions affecting movement and coordination.

“PoNS therapy leverages neuromodulation by delivering electrical stimulation to specific brain regions, guiding their function. The more a patient engages in movement – walking, exercising, or performing rehabilitative tasks – the more the brain learns to utilise compensatory pathways, facilitating adaptive changes.

“This process is linked to neuroplasticity, the brain’s ability to reorganise itself by forming new neural connections. However, neuroplasticity takes time; it is not an immediate response to neuromodulation. Neuromodulation alone does not trigger long-term changes unless it is reinforced by consistent functional activity.

“Crucially, neuroplasticity is an irreversible process – once the brain has successfully established new pathways, it does not revert to its pre-impairment state. In contrast, neuromodulation is a temporary mechanism; electrical stimulation prompts a response, but without continuous reinforcement, it does not lead to lasting structural changes.

“Therefore, persistent engagement in therapy is essential to induce neuroplasticity and achieve meaningful, long-term rehabilitation.”

The study

The PoNSTEP study was specifically designed to examine adherence to treatment – meaning how consistently patients maintained their rehabilitation programme.

The study demonstrated that patients who adhered to the recommended PoNS therapy dosage – the dosage shown in clinical trials to be effective through the neuroplasticity mechanism – achieved significant improvements in gait and balance.

“Those who adhered to the therapy at a rate of 70 to 85 per cent or higher (equating to 100 to 120 minutes per day over 14 weeks) experienced improvements comparable to those seen in clinical trials. In contrast, patients with lower adherence levels saw reduced benefits,” says Favit-Van Pelt.

“One of the most crucial findings of the study is the clear linear correlation between adherence and improvement – the more consistently patients followed the treatment protocol, the greater their improvements in gait and mobility. Those who adhered fully to the clinical trial dosage achieved the maximum benefits.

“Additionally, neuroplasticity is an irreversible process. Once neuroplasticity has been triggered and functional improvements have been achieved, they should be maintained over time. In earlier studies using physical therapy alone, we observed patients beginning to decline once therapy ceased.

“However, in the study, we followed patients for an additional six months after completing their 14-week programme. Of the 38 participants who completed the full protocol, 26 returned for follow-up assessments.

“Remarkably, 93 per cent of them maintained their improvements, with only one patient experiencing a decline greater than 30 per cent – the threshold we used to indicate significant deterioration and the need for retreatment.”

Favit-Van Pelt explains that there is a minimum threshold of adherence required, and that the adherence is linearly correlated with improvement – the more consistently a patient engages in the therapy, the greater their improvement.

“PoNS therapy is based on the concept of intensive rehabilitation, meaning patients must actively engage in physical exercise while using the device,” says Favit-Van Pelt.

“The therapy is structured to include three distinct 20-minute sessions: one during gait exercises, one during balance exercises, and one in a state of mindfulness, where no physical activity is performed. This final session is crucial, as it helps consolidate the brain’s learning after the gait and balance exercises.

“This cognitive consolidation is a key component of how PoNS therapy works, as it leverages a specific form of neuroplasticity known as compensatory masquerade. This mechanism allows the brain to develop new strategies or pathways to achieve a function following an injury.

“Essentially, the brain compensates for the deficit by using alternative cognitive processes to perform the desired task.

“What sets PoNS apart from other therapies is its ability to selectively activate areas of the brain responsible for the cognitive control of movement and coordination. Imaging data supports the idea that PoNS therapy promotes neuroplasticity through compensatory masquerade, as it engages cognitive processes to build new pathways and rehabilitate function.

“For patients, the goal should be to maximise the effectiveness of their rehabilitation, but it is not solely about time spent – it is about intensity and quality. A patient may complete the recommended 20-minute gait rehabilitation session, but their progress depends on how effectively they engage with the exercises.

“The same applies to balance exercises. Those who increase intensity and perform the exercises correctly have the highest chances of achieving maximum improvement.”

Adherence can be challenging, says Favit-Van Pelt, particularly for patients with MS, TBI, stroke, or other neurological conditions affecting gait and balance, as they often experience fatigue.

“This therapy is not something a patient can master on day one,” says Favit-Van Pelt.

“It is a gradual process that builds endurance over time. However, this principle applies to all forms of rehabilitation. For example, if someone undergoes knee surgery, they cannot perform the same exercises on the first day as they would three months into recovery.

“Rehabilitation is a progressive process, and PoNS therapy enhances the benefits of conventional rehabilitation by optimising the body’s ability to improve.”

An important aspect of the therapy is also the element of mindfulness, utilising 20 minute sessions after exercises to help the brain consolidate what it has learned.

“The reason we ask patients to engage in physical activity is clear,” says Favit-Van Pelt. “They need to move in order to regain function, improve gait, and maintain balance while walking. However, PoNS therapy works by upregulating cognitive control, meaning that once the brain receives input from the device, it must consolidate this new mechanism to retain it.

“This is why we incorporate a 20-minute mindfulness session after the physical exercises. During this period, patients engage in what is known as ‘gait imagery’—mentally rehearsing their exercises and reinforcing the memory of the movements they have performed. By doing so, the brain not only processes the input it received during the exercises but also strengthens those neural pathways through cognitive mechanisms.

“This helps to consolidate learning, making rehabilitation more effective and ensuring that the brain retains and refines the improvements achieved during therapy.”

Findings from the study will be presented at the Consortium of Multiple Sclerosis Centres (CMSC) and at ACTRIMS on 27 February as a poster presentation. The preliminary results, focusing on adherence during phase one and phase two of the study, will be shared at ACTRIMS, while the full study results will be presented at CMSC in May.

Future plans include expanding in stroke with potential FDA authorisation in 2025.