Session Information
Date: Friday, November 15, 2019
Session Title: Neurological Rehabilitation Research Report
Session Time: 12:30pm-2:00pm
Location: Research Hub - Kiosk 6
Disclosures: Linda Papa, MD: Nothing to disclose
Objective: To determine whether training using the PoNS™ at a high-frequency pulse (HFP) is more efficacious than training using a very low, but perceivable, frequency pulse (LFP) combined with targeted physical therapy (PT) in participants with balance deficits due to mild-to-moderate traumatic brain injury (mmTBI).
Design: This double-blind, randomized controlled trial included a 5-week course of standard PT focusing on balance and gait, together with breathing and awareness training combined with PoNS™ (PoNS™ Treatment).
Setting: This study was conducted at academic centers and clinics in the United States and Canada.
Participants: Subjects had their most recent mmTBI ≥1 year prior to enrollment and had a NeuroCom Sensory Organization Test (SOT) composite score >16 points below normal after adjustment for age. All subjects had received prior PT and had been deemed to have reached a plateau by their healthcare provider.
Interventions: PoNS™ is a novel translingual neurostimulation device that applies sequenced electrotactile stimulation to the tongue. Participants were randomized into HFP and LFP PoNS™ Treatment groups.
Main Outcome Measures: The primary endpoint was an increase in SOT score by ≥15 points at 5 weeks (SOT responders), with a secondary endpoint at 2 weeks.
Results: 122 subjects were enrolled, and 71.2% in the HFP group and 63.5% in the LFP group were SOT responders (P=.081). Pooling of results from the two groups indicated a responder rate of 67.2%. The mean change in SOT score for the combined group was 18.3 (P<.0005) from baseline to week 2 and 24.6 (P<.0005) from baseline to week 5. Treatment also resulted in reductions in falls and headaches and improved sleep and quality of life.
Conclusions: The results of this controlled clinical trial indicate that PoNS™ Treatment with either HFP or LFP stimulation combined with PT produced significant improvements in balance and also helped decrease the number of falls in subjects with mmTBI.
Level of Evidence: Level I
To cite this abstract in AMA style:
Papa L, Ptito A. Translingual Neurostimulation with the Portable Neuromodulation Stimulator (PoNS™) for the Treatment of Chronic Balance Deficit Due to Mild-to-Moderate Traumatic Brain Injury [abstract]. PM R. 2019; 11(S2)(suppl 2). https://pmrjabstracts.org/abstract/translingual-neurostimulation-with-the-portable-neuromodulation-stimulator-pons-for-the-treatment-of-chronic-balance-deficit-due-to-mild-to-moderate-traumatic-brain-injury/. Accessed November 22, 2024.« Back to AAPM&R Annual Assembly 2019
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/translingual-neurostimulation-with-the-portable-neuromodulation-stimulator-pons-for-the-treatment-of-chronic-balance-deficit-due-to-mild-to-moderate-traumatic-brain-injury/