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.