Translingual Neurostimulation for the Treatment of Chronic Symptoms Due to Mild-to-Moderate Traumatic Brain Injury

Autor: Mitchell Tyler, MS, Kim Skinner, DPT, Vivek Prabhakaran, MD, PhD, Kurt Kaczmarek, PhD, Yuri Danilov, PhD
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Archives of Rehabilitation Research and Clinical Translation, Vol 1, Iss 3, Pp - (2019)
Druh dokumentu: article
ISSN: 2590-1095
DOI: 10.1016/j.arrct.2019.100026
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
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