Translingual Neurostimulation

New Opportunities in
Motor Rehabilitation

TLNS activates key brain control centers — the brainstem and cerebellum — through the body's own natural neural pathways. This allows the brain to begin reorganizing and self-repairing through a process called neuroplasticity.
Medical and Technological Evolution
Our Company
Our Company

The RehaLine Group of Companies manufactures TLNS neurostimulation equipment and operates rehabilitation centers where specialist training is conducted and patients receive rehabilitation treatment.

Engaged in the development of rehabilitation treatment protocols for various conditions, we have contributed to over 36 scientific publications and conducted clinical studies with more than 500 patients in several countries..

Our aim is to offer new opportunities in motor rehabilitation by activating key brain control centers - the brainstem, and cerebellum, through the body's natural neural pathways. This process, known as neuroplasticity, enables the brain to reorganize and self-repair.

36+
Scientific Publications
500+
Patients in Clinical Studies
4
Countries with Regulatory Approvals
What is TLNS?

If your child has cerebral palsy, or if you or a loved one is recovering from a traumatic brain injury, stroke, or living with multiple sclerosis, you understand the challenges of finding effective treatment. You may have already explored options like physical therapy and medications. However, you might be curious if there are other solutions available.

One such solution is Translingual Neurostimulation (TLNS), which offers a unique approach to neurorehabilitation. TLNS involves a non-invasive technique that utilizes mild electrical impulses on the tongue's surface to stimulate the brain's natural recovery mechanisms. During therapeutic exercises, a portable neurostimulator is placed on the tongue. Patients typically experience a gentle sensation described as a light tingling, similar to the effervescence of sparkling water, and it is entirely painless.

By targeting crucial brain control centers like the brainstem and cerebellum through the body's natural neural pathways, TLNS kickstarts the brain's reorganization and self-repair processes via neuroplasticity.

What is TLNS?
Regulatory Approvals

TLNS has received approval for medical use from regulatory bodies in various countries:

Mexico
Mexico
Comisión Federal para la Protección contra Riesgos Sanitarios
Canada
Canada
(Health Canada) for specific conditions
Australia
Australia
(TGA) as an adjunct to physical therapy
Russia
Russia
Approved for cerebral palsy and other neurological conditions
TLNS Mechanism: Activating Neuroplasticity
How TLNS Works

Treatment Process

  1. Patient places TLNS electrode on the tongue
  2. Performs targeted exercises for 20 minutes with stimulation
  3. Typically 2–3 times per day
  4. Initial 2 weeks under supervision in clinic
  5. Then independently at home for 12 weeks (TBI) or 10-day cycles (CP)
Why the Tongue?

The tongue's significance in neuroscience is rooted in its remarkable sensitivity. With around 20,000–25,000 nerve fibers densely packed in a small area, the tongue stands out as the most tactilely sensitive surface in the human body. For mechanical stimulation, the tongue's minimum two-point discrimination threshold is merely 0.5–1 mm, while for electrical stimulation, it is an astonishingly low 0.25–0.5 mm — surpassing the sensitivity of any other skin surface.

Moreover, the tongue offers an optimal setting for electrical stimulation due to its stable pH level, temperature, and humidity, along with very low excitability thresholds. Consequently, even weak electrical impulses can be efficiently transmitted to the nervous system through the tongue.

The Neural Pathway

When the TLNS device administers electrical impulses to the tongue's surface, the process unfolds as follows:

Step 1

Surface Stimulation

The TLNS device features 139 gold-plated electrodes, with only 9 electrodes active at a time, covering 0.16 cm² of the tongue's surface. The voltage remains fixed at 19 V, with a pulse duration ranging from 0.4 to 60 microseconds. Ultrashort electrical impulses in the tongue epithelia (500-800 mkm) activate various receptors, converting them into neural impulses.

Step 2

Cranial Nerve Activation

Neural impulses travel through two major cranial nerves:
- The lingual branch of the trigeminal nerve (CN-V) carries around 20,000–22,000 nerve fibers.
- The chorda tympani of the facial nerve (CN-VII) carries about 3,000–6,000 nerve fibers. These nerves transmit activation to the brainstem (from midbrain to spinal cord, C1-C3) and cerebellum.

Step 3

Brainstem and Cerebellum

Nerve impulses reach brainstem structures like trigeminal nuclei complex, solitary nuclei (NTS), and the cerebellum, responsible for balance and movement control. Activation spreads to the reticular formation, locus coeruleus, and vestibular nuclei, engaging the entire neural system from the frontal cortex to the lumbar spine segment in milliseconds.

Step 4

Neuroplasticity

Prolonged stimulation during therapy induces Long-Term Potentiation (LTP), enhancing neural pathways and forming new synaptic connections, showcasing neuroplasticity.

Neuroimaging Data

Brain imaging studies have confirmed that TLNS causes measurable changes in the brain:

EEG Study (Frehlick/D'Arcy et al., 2019)

EEG Study (Frehlick/D'Arcy et al., 2019)

A single 20-minute PoNS session significantly altered resting-state brain activity — with increased alpha and theta power and changes in attention microstates that persisted for at least 20 minutes after stimulation.
Structural MRI Study (D'Arcy et al., 2019)

Structural MRI Study (D'Arcy et al., 2019)

After 2 weeks of TLNS + physical therapy, TBI patients showed significant changes in gray matter volume and cortical thickness, with correlation between structural brain changes and functional improvement.

These studies provide objective, measurable evidence that TLNS causes real physical changes in the brain — this is not a placebo effect.

TLNS vs. Conventional Neurostimulation
How Does TLNS Differ from Other Methods?

Unlike other neurostimulation methods (transcranial magnetic stimulation, transcranial direct current stimulation, vagus nerve stimulation), TLNS stimulates nerve receptors and endings rather than nerve trunks.

This makes it closer to natural stimulation. In essence, TLNS is a non-invasive version of Deep Brain Stimulation (DBS), accessing the brainstem through natural sensory pathways rather than surgical implants.

It simultaneously combines properties of trigeminal nerve stimulation and vagus nerve stimulation — but non-invasively. And because it activates the brainstem and cerebellum broadly (rather than targeting a single limb), it can lead to improvements across multiple systems: balance, gait, spasticity, motor skills, cognitive function, headaches, and sleep.

How Does TLNS Differ from Other Methods?
Technology Advantages
Timelines and High Effectiveness
Timelines and High Effectiveness

Motor rehabilitation with TLNS shows rapid and significant improvements

No Physical Limitations
No Physical Limitations

TLNS has no weight or height restrictions and works for children from age 2 and adults up to 65+ years

Family-Friendly
Family-Friendly

After initial 2-week clinical training, a parent can supervise home therapy. No specialist needed at every session

Time-Saving
Time-Saving

20-minute sessions, 2–3 times per day, at home — instead of clinic visits plus travel time

Portability
Portability

The PoNS device fits in the palm of your hand. Can be taken on trips, used while traveling

Clinical Evidence

The evidence base for TLNS is built on multiple clinical studies conducted at leading scientific institutions in North America and Europe. Here we present the key results in plain language, with real numbers from the studies.

Assessment Scales and Questionnaires

Before reviewing the results, here are the key tests that physicians use:

SOT (Sensory Organization Test): Measures balance on a scale from 0 to 100. Healthy adults score above 69 points. An improvement of 8.48 or more points is considered "clinically significant" — meaning noticeable in everyday life.

GMFCS (Gross Motor Function Classification System): Evaluates motor abilities in children with CP on a scale from 1 to 5 (1 = walks without limitations, 5 = transported in a wheelchair). Lower is better.

Berg Balance Scale: Measures the ability to maintain balance on a scale from 0 to 56. Higher is better.

DGI (Dynamic Gait Index): Measures the ability to walk while performing various tasks. A change of 3+ points is clinically significant.

FMS (Functional Mobility Scale): Measures how independently a child can move over distances of 5 m, 50 m, and 500 m.

All instruments are objective, standardized, and used in leading neurological rehabilitation centers.

Cerebral Palsy

The Study: The largest study of TLNS in cerebral palsy was conducted at City Hospital No. 40 in Saint Petersburg under the leadership of Dr. Tatyana Ignatova and colleagues (2019). This controlled clinical study included 134 children aged 2 to 17 years (mean age 7.8 years) with spastic diplegia — the most common form of CP.

Experimental group: 94 children received standard rehabilitation + TLNS via the PoNS device

Control group: 40 children received standard rehabilitation only

Treatment: 10 daily sessions of 20 minutes each per cycle

Motor Skills (GMFCS) — lower GMFCS = better motor function
Period TLNS Group Control Group
Before Cycle 1 3.5 3.7
After Cycle 1 3.0 (−13%) 3.4 (−5%)
After Cycle 2 2.8 (−11%)
After Cycle 3 2.4 (−10%)

What this means: Children receiving TLNS improved motor function nearly 3 times faster than children on standard therapy. After 3 treatment cycles, children in the TLNS group improved from GMFCS 3.5 to 2.4 — a dramatic change in functional capabilities. A child at GMFCS 3.5 typically needs a wheelchair for long distances; at 2.4, they can walk with minimal assistance in most situations.

Balance (Berg Scale) — Higher is Better
Period TLNS Group Control Group
Before Cycle 1 16.8 12.1
After Cycle 1 23.9 (+42%) 15.9 (+32%)
After Cycle 2 29.8 (+30%) 17.4
After Cycle 3 31.1 (+21%)

In individual cases, cumulative balance improvement reached 144% and 229% over 4 treatment cycles.

Functional Mobility (FMS) after the first TLNS cycle:
  • 5-meter walk: +59% improvement
  • 50-meter walk: +51% improvement
  • 500-meter walk: +31% improvement

The control group showed +30%, +17%, and no significant improvement at these distances, respectively.

Spasticity Reduction

This result is particularly important for CP families, as spasticity (muscle stiffness) is one of the most challenging aspects of the condition:

  • Arms: 13–17% reduction per cycle with TLNS
  • Legs: 17–23% reduction per cycle with TLNS
  • Cumulative reduction after 3 cycles: 40–60%

And here is the most outstanding result: the spasticity reduction was cumulative. In the control group, spasticity returned to baseline between treatment cycles. In the TLNS group, it did not. Each cycle built upon the results of the previous one.

This cumulative effect has not been observed with any other form of neurostimulation or rehabilitation. This means that with TLNS, children don't just improve and then regress — they continue to progress with each treatment cycle.

Why This Matters for Your Child

The CP study identified several results directly relevant to families:

Children over 7 years showed similar positive results.

Many therapies lose effectiveness as children age past the "critical window" of motor development. TLNS appears to work even in older children.

No negative side effects.

No occurrence or worsening of seizures was recorded in children with pre-existing epileptic activity. No serious adverse events.

The cumulative effect enables long-term treatment planning.

Treatment cycles can be planned at 6–12 month intervals, knowing that each cycle will build on the previous one.

Brain imaging (fMRI) confirmed the changes.

A companion study by Efimtsev et al. (2019) showed that TLNS increased global brain network efficiency and improved functional connectivity — and the changes were sustained at follow-up.

Traumatic Brain Injury

Study 1: Single-Center (University of Wisconsin)

Publication: Tyler et al., Archives of Rehabilitation Research and Clinical Translation, 2019

Design: 26-week randomized double-blind study

Participants: 44 adults with chronic mild-to-moderate TBI

Registration: NCT02158494

This study was carefully designed: patients were randomly assigned to high-frequency (HFP) or low-frequency (LFP) stimulation groups, with neither patients nor therapists knowing which group they were in. The study had 3 phases: 2 weeks in the clinic, 12 weeks of treatment at home, and 12 weeks without treatment (to test whether results were maintained).

Key point: All participants had already plateaued with conventional physical therapy before enrollment. They were considered "chronic" — their TBI symptoms were not improving with standard treatment.

Balance Results (SOT Composite Score)

Period HFP Group LFP Group Significance
Week 2 +21.0 +25.3 p < 0.0001
Week 5 +26.0 +28.5 p < 0.0001
Week 14 +29.8 +35.0 p < 0.0001
Week 26 +33.8 +33.8 p < 0.0001

What this means: Remember that 8.48 points is considered clinically significant. These patients improved by 21–35 points — 2.5–4 times above the clinical significance threshold. By week 14, SOT scores reached the normal range (above 69). And improvements were maintained 12 weeks after stopping treatment (week 26 data).

Additional Results:

  • Headaches: HDI scores decreased by approximately 40%;
  • Sleep: PSQI scores improved, especially the sleep-wake cycle;
  • Gait: Dynamic Gait Index improved significantly (p < 0.001–0.01) at all time points;
  • Safety: Zero serious adverse events related to treatment. Only mild device effects (tongue tingling).

Study 2: Multi-Center (7 sites in the US and Canada)

Publication: Ptito et al., Neuromodulation, 2020

Design: Prospective multi-center randomized double-blind study

Participants: 122 adults with chronic mild-to-moderate TBI

Sites: 7 clinics in the US and Canada

Registration: NCT02429167

This larger study confirmed the single-center results across multiple clinical sites. Median time since injury was 5.7 years, and participants had undergone an average of 8.8 months of prior physical therapy without further improvement.

Key Results:

  • Responder rate (SOT improvement ≥15 points): 67.2% of all participants
  • HFP group: 71.2%
  • LFP group: 63.5%
  • Both statistically significant (p < 0.0005)
  • Mean SOT improvement by week 5: 24.6 points (SD: 18.8)
  • Gait (DGI): Significant improvement (p < 0.0001) at weeks 2 and 5
  • Falls: Both groups showed a reduction in falls
  • Headaches: HDI scores significantly decreased
  • Sleep: SQI scores significantly improved
  • Treatment adherence: 94% average adherence at weeks 2–5

Safety: 22 device-related adverse events in 12 participants — all mild. Most common: tongue burning sensation (6 cases), tongue tingling (4 cases), tongue soreness (3 cases). Zero serious adverse events.

What This Means for TBI Patients

If you have chronic balance problems after TBI and feel you've "hit a wall" with conventional therapy:

Two‑thirds of patients improved

67.2% responder rate (SOT improvement ≥15 points). These were patients who had already stopped improving with physical therapy alone — yet TLNS produced meaningful, measurable gains.

Results were maintained

No need to use the device permanently. In the 26‑week Wisconsin trial, SOT improvements were fully sustained 12 weeks after stopping treatment (week 26: +33.8 points, p < 0.0001). Gains persist without ongoing stimulation.

Multiple symptoms improved simultaneously

Balance, gait, headaches, and sleep — not just one domain. Dynamic Gait Index (p < 0.0001), HDI headache scores (~40% reduction), and PSQI/SQI sleep quality all improved. Real-world multi‑system benefit.

Treatment is safe

With 166 participants across both studies — zero serious adverse events. Only mild, transient tongue sensations (tingling/burning). No device‑related SAEs. Excellent adherence (94% in the multi‑center trial).

Multiple Sclerosis

Montreal Neurological Institute Study (Leonard et al., 2017):

14 patients received active PoNS or sham device + 14 weeks of intensive therapy. The active device group showed significant SOT improvement, significant fMRI changes in the left primary motor cortex, and increased activity in the dorsolateral prefrontal cortex (working memory). Results suggest that TLNS improves both motor function and cognitive abilities by stimulating neuroplasticity.

Gait Study (Tyler et al., 2014):

20 MS patients showed significant improvement in the Dynamic Gait Index over 14 weeks of TLNS + physical therapy.

Stroke

Pilot Study (Galea et al., 2017):

5 patients in the subacute stroke phase in a randomized controlled pilot study showed significant improvement on the Mini-Balance Evaluation in just 2 weeks of TLNS + targeted physical therapy. Health Canada subsequently authorized TLNS for gait deficits in stroke.

Patient Stories
About Realistic Expectations

We include these stories to give you an idea of real-world outcomes, not to make promises. Every patient is different. Clinical study data provides the most reliable picture: approximately two-thirds of TBI patients improved significantly, and children with CP showed consistent improvement across multiple cycles.

Not every patient will have impressive results. But the data shows that a significant majority of patients — including those who had stopped improving with other treatments — benefit from TLNS.

Frequently Asked Questions

Is TLNS painful?

No. Most patients describe the sensation as a light tingling or prickling, similar to sparkling water on the tongue. The intensity is adjustable. In clinical studies involving over 500 patients, not a single serious adverse event was recorded.

How long does treatment last?

Each PoNS session lasts 20 minutes, performed 2–3 times per day alongside therapeutic exercises. For TBI, the full protocol includes 2 weeks of training at the clinic, then 12 weeks of therapy at home. For CP in children, treatment is conducted in 10-day cycles that can be repeated every 6–12 months.

Can children use TLNS?

Yes. TLNS has been studied in children as young as 2 years of age with cerebral palsy. The CP study included 134 children aged 2 to 17 years with positive results and no safety concerns.

What conditions can TLNS treat?

TLNS is approved/authorized for: gait deficits in MS (FDA, Health Canada, Australia), chronic balance deficit in TBI (Health Canada), gait deficits in stroke (Health Canada), and cerebral palsy (Russia).

Can TLNS replace physical therapy?

No. TLNS is designed as an adjunct to physical therapy — it enhances the effect of therapeutic exercises. The device is used during physical therapy sessions. Think of TLNS as an amplifier for your physical therapy, not a replacement.

Are there contraindications?

TLNS should not be used during pregnancy, with known sensitivity to nickel, gold, or copper (electrode materials), with active or suspected malignant tumors, with recent bleeding or open wounds in the oral cavity, or in the absence of normal sensation. Always consult your healthcare provider.