دورية أكاديمية

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

التفاصيل البيبلوغرافية
العنوان: Translingual Neurostimulation for the Treatment of Chronic Symptoms Due to Mild-to-Moderate Traumatic Brain Injury.
المؤلفون: Tyler M; Department of Biomedical Engineering, University of Wisconsin-Madison, Madison, Wisconsin.; Department of Kinesiology, University of Wisconsin-Madison, Madison, Wisconsin., Skinner K; Department of Kinesiology, University of Wisconsin-Madison, Madison, Wisconsin., Prabhakaran V; Department of Radiology, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin., Kaczmarek K; Department of Kinesiology, University of Wisconsin-Madison, Madison, Wisconsin., Danilov Y; Department of Kinesiology, University of Wisconsin-Madison, Madison, Wisconsin.
المصدر: Archives of rehabilitation research and clinical translation [Arch Rehabil Res Clin Transl] 2019 Sep 27; Vol. 1 (3-4), pp. 100026. Date of Electronic Publication: 2019 Sep 27 (Print Publication: 2019).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Elsevier Inc Country of Publication: United States NLM ID: 101763542 Publication Model: eCollection Cited Medium: Internet ISSN: 2590-1095 (Electronic) Linking ISSN: 25901095 NLM ISO Abbreviation: Arch Rehabil Res Clin Transl Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: [New York] : Elsevier Inc., [2019]-
مستخلص: 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 <.0001) improvement in SOT scores from baseline at weeks 2, 5, 14 (primary endpoint), and 26. DGI scores had significant improvement ( P <.001-.01) from baseline at the same test points; 6MWT evaluations after 2 weeks were significant. The SOT, DGI, and 6MWT scores did not significantly differ between arms at any test point. There were no treatment-related serious adverse events.
Conclusions: Both the HFP+PT and LFP+PT groups had significantly improved balance scores, and outcomes were sustained for 12 weeks after discontinuing TLNS treatment. Results between arms did not significantly differ from each other. Whether the 2 dosages are equally effective or whether improvements are because of provision of PT cannot be conclusively established at this time.
(© 2019 The Authors.)
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فهرسة مساهمة: Keywords: 6MWT, 6-minute walk test*; AE, adverse event*; ANOVA, analysis of variance*; Balance*; DGI, Dynamic Gait Index*; Facial nerve*; Gait*; HFP, high-frequency pulse*; ITP, in-clinic training program*; LFP, low-frequency pulse*; Neurostimulation*; PSQI, Pittsburgh Sleep Quality Index*; PT, physical therapy*; PoNS, portable neuromodulation stimulator*; Rehabilitation*; SOT, Sensory Organization Test*; TBI, traumatic brain injury*; TLNS, translingual neurostimulation*; Trigeminal nerve*; mmTBI, mild-to-moderate traumatic brain injury*
تواريخ الأحداث: Date Created: 20210205 Latest Revision: 20240806
رمز التحديث: 20240806
مُعرف محوري في PubMed: PMC7853385
DOI: 10.1016/j.arrct.2019.100026
PMID: 33543056
قاعدة البيانات: MEDLINE
الوصف
تدمد:2590-1095
DOI:10.1016/j.arrct.2019.100026