Translingual neural stimulation to improve gait and balance in multiple sclerosis: A randomized controlled trial.

OBJECTIVE

Translingual neurostimulation (TLNS) is a promising neuromodulation technique. This Phase II randomized sham-controlled trial aimed to determine the efficacy of adding TLNS to 14 weeks of gait and balance physical therapy (PT+TLNS) among people with multiple sclerosis (MS).

DESIGN

Participants completed PT while wearing a device intended to activate vestibular networks in the brainstem (TLNS or Sham, PoNS™, Helius Medical Technologies, Newtown PA, USA). The primary outcomes were the Dynamic Gait Index (DGI) and fast walking speed. Secondary outcomes included Mini-BESTest, MS Impact Scale-29, MS Walking Scale-12, Fatigue Scale for Motor and Cognitive Functions, and Short Form-36.

SETTING

Research centers and PT clinic in Canada.

PARTICIPANTS

People experiencing mild to moderate MS-related gait impairment.

RESULTS

Controlling for baseline factors, the groups (PT+TLNS [n=21], PT+Sham [n=23]) were not significantly different from one another for either the primary outcome, DGI (mean difference = 0.8, 95% CI=[-1.5, 3.1]), or any of the secondary gait and balance outcomes. Both groups improved from baseline (DGI mean change = 2.9, 95% CI = [1.8, 4.0]; MiniBEST mean change = 3.1, 95% CI=[2.0, 4.3]), with the exception of walking speed. The PT+TLNS and PT+Sham groups wore the device 70.3% and 53.5% of the prescribed amount and PT session adherence was 91.1% and 82.3%, respectively. The PT+TLNS group experienced greater improvements in cognitive fatigue and mental health quality-of-life.

CONCLUSIONS

PT improved dynamic gait and balance among persons with MS. TLNS, at the dosage provided in this study, did not confer added benefit.