Translingual Neurostimulation for the Treatment of Chronic Symptoms Due to Mild-to-Moderate Traumatic Brain Injury
| Autor: | Yuri Danilov, Mitchell E. Tyler, Kurt A. Kaczmarek, Vivek Prabhakaran, Kim Skinner |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Balance
medicine.medical_specialty 6MWT 6-minute walk test Dose PSQI Pittsburgh Sleep Quality Index Traumatic brain injury mmTBI mild-to-moderate traumatic brain injury medicine.medical_treatment Trigeminal nerve ITP in-clinic training program DGI Dynamic Gait Index Facial nerve TBI traumatic brain injury medicine Clinical endpoint Neurostimulation PoNS portable neuromodulation stimulator Adverse effect Gait ANOVA analysis of variance PT physical therapy Balance (ability) Original Research lcsh:R5-920 Rehabilitation TLNS translingual neurostimulation business.industry HFP high-frequency pulse General Medicine medicine.disease LFP low-frequency pulse Physical therapy business lcsh:Medicine (General) AE adverse event SOT Sensory Organization Test |
| Zdroj: | Archives of Rehabilitation Research and Clinical Translation, Vol 1, Iss 3, Pp-(2019) Archives of Rehabilitation Research and Clinical Translation |
| ISSN: | 2590-1095 |
| Popis: | Objective: To compare the efficacy of high- and low-frequency noninvasive translingual neurostimulation (TLNS) plus targeted physical therapy (PT) for treating chronic balance and gait deficits due to mild-to-moderate traumatic brain injury (mmTBI). Design: Participants were randomized 1:1 in a 26-week double-blind phase 1/2 study (NCT02158494) with 3 consecutive treatment stages: in-clinic, at-home, and no treatment. Arms were high-frequency pulse (HFP) and low-frequency pulse (LFP) TLNS. Setting: TLNS plus PT training was initiated in-clinic and then continued at home. Participants: Participants (N=44; 18-65y) from across the United States were randomized into the HFP and LFP (each plus PT) arms. Forty-three participants (28 women, 15 men) completed at least 1 stage of the study. Enrollment requirements included an mmTBI ≥1 year prior to screening, balance disorder due to mmTBI, a plateau in recovery with current PT, and a Sensory Organization Test (SOT) score ≥16 points below normal. Interventions: Participants received TLNS (HFP or LFP) plus PT for a total of 14 weeks (2 in-clinic and 12 at home), twice daily, followed by 12 weeks without treatment. Main Outcome Measures: The primary endpoint was change in SOT composite score from baseline to week 14. Secondary variables (eg, Dynamic Gait Index [DGI], 6-minute walk test [6MWT]) were also collected. Results: Both arms had a significant (P |
| Databáze: | OpenAIRE |
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