A Prospective, Multicenter Study to Assess the Safety and Efficacy of Translingual Neurostimulation Plus Physical Therapy for the Treatment of a Chronic Balance Deficit Due to Mild-to-Moderate Traumatic Brain Injury.
Balance
clinical trial
gait
randomized
traumatic brain injury
Journal
Neuromodulation : journal of the International Neuromodulation Society
ISSN: 1525-1403
Titre abrégé: Neuromodulation
Pays: United States
ID NLM: 9804159
Informations de publication
Date de publication:
Dec 2021
Dec 2021
Historique:
revised:
28
02
2020
received:
15
10
2019
accepted:
23
03
2020
pubmed:
30
4
2020
medline:
18
12
2021
entrez:
30
4
2020
Statut:
ppublish
Résumé
Translingual neurostimulation (TLNS) studies indicate improved outcomes in neurodegenerative disease or spinal cord injury patients. This study was designed to assess the safety and efficacy of TLNS plus targeted physical therapy (PT) in people with a chronic balance deficit after mild-to-moderate traumatic brain injury (mmTBI). This international, multicenter, randomized study enrolled 122 participants with a chronic balance deficit who had undergone PT following an mmTBI and had plateaued in recovery. Randomized participants received PT plus either high-frequency pulse (HFP; n = 59) or low-frequency pulse (LFP; n = 63) TLNS. The primary efficacy and safety endpoints were the proportion of sensory organization test (SOT) responders (SOT composite score improvement of ≥15 points) and fall frequency after five weeks of treatment, respectively. The proportion of SOT responders was significant in the HFP + PT (71.2%) and LFP + PT (63.5%) groups compared with baseline (p < 0.0005). For the pooled population, the SOT responder rate was 67.2% (p < 0.00005), and there were clinically and statistically significant improvements in SOT composite scores after two and five weeks (p < 0.0005). Both groups had reductions in falls and headache disability index scores. Mean dynamic gait index scores in both groups also significantly increased from baseline at weeks 2 and 5. Significant improvements in balance and gait, in addition to headaches, sleep quality, and fall frequency, were observed with TLNS plus targeted PT; in participants who had a chronic balance deficit following an mmTBI and had plateaued on prior conventional physiotherapy.
Identifiants
pubmed: 32347591
doi: 10.1111/ner.13159
pii: S1094-7159(21)06897-5
pmc: PMC9291157
doi:
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1412-1421Subventions
Organisme : Helius Medical Inc
Organisme : US Army Medical Research and Materiel Command (USAMRMC)
Informations de copyright
© 2020 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals LLC on behalf of International Neuromodulation Society.
Références
Pain. 2015 Oct;156(10):2093-2099
pubmed: 26101836
Clin J Pain. 2009 Jan;25(1):12-9
pubmed: 19158541
Brain Inj. 1997 Sep;11(9):661-75
pubmed: 9376834
Injury. 2016 Jan;47(1):109-15
pubmed: 26283084
Lancet Neurol. 2019 Jan;18(1):56-87
pubmed: 30497965
Arch Phys Med Rehabil. 2014 Dec;95(12):2435-43
pubmed: 24814561
J Geriatr Phys Ther. 2011 Jul-Sep;34(3):131-7
pubmed: 21937903
Arch Phys Med Rehabil. 2015 Feb;96(2):379-80
pubmed: 25618196
J Head Trauma Rehabil. 2008 Mar-Apr;23(2):123-31
pubmed: 18362766
Arch Phys Med Rehabil. 2004 Feb;85(2):227-33
pubmed: 14966706
Neuropathol Appl Neurobiol. 2013 Oct;39(6):654-66
pubmed: 23231074
J Affect Disord. 2017 Jun;215:187-196
pubmed: 28340445
Front Neurol. 2018 Dec 19;9:1113
pubmed: 30619066
CMAJ. 2011 May 17;183(8):905-11
pubmed: 21502355
Disabil Rehabil. 2012;34(9):788-94
pubmed: 22149161
Brain Inj. 2011;25(7-8):664-79
pubmed: 21561297
J Psychiatr Res. 2017 Jun;89:125-135
pubmed: 28278422
Mult Scler J Exp Transl Clin. 2017 Feb 01;3(1):2055217317690561
pubmed: 28607750
Brain Connect. 2013;3(1):87-97
pubmed: 23216162
Brain Stimul. 2013 Jul;6(4):631-40
pubmed: 23122916
J Neurotrauma. 2018 Jun 1;35(11):1205-1212
pubmed: 29343158
Lancet. 1974 Jul 13;2(7872):81-4
pubmed: 4136544
Brain Inj. 2005 Nov;19(12):989-1000
pubmed: 16263641
Br J Sports Med. 2017 Mar;51(5):442-451
pubmed: 27655831
Rheumatol Int. 1984;4(3):119-23
pubmed: 6611576
Neuromodulation. 2012 Jul;15(4):326-38
pubmed: 22882244
N Engl J Med. 1990 Jun 7;322(23):1627-34
pubmed: 2140432
Am J Sports Med. 2013 Jul;41(7):1497-504
pubmed: 23698389
J Clin Epidemiol. 2000 Aug;53(8):786-92
pubmed: 10942860
Acta Neurol Belg. 2017 Jun;117(2):547-549
pubmed: 28185179
Headache. 2016 Sep;56(8):1317-32
pubmed: 27593728
Brain. 2005 Mar;128(Pt 3):606-14
pubmed: 15634727
J Rehabil Res Dev. 2012;49(7):971-84
pubmed: 23341273
J Neuroeng Rehabil. 2014 Jun 06;11:96
pubmed: 24906679
Neurology. 2018 Jul 24;91(4):e364-e373
pubmed: 29907608
JAMA Pediatr. 2016 Jul 1;170(7):647-53
pubmed: 27135397
J Neuroeng Rehabil. 2014 May 01;11:79
pubmed: 24885412
Brain Imaging Behav. 2010 Dec;4(3-4):199-211
pubmed: 20614202
Clin J Sport Med. 2008 Mar;18(2):148-54
pubmed: 18332690
Brain. 2008 Nov;131(Pt 11):2812-23
pubmed: 18567924
Can Fam Physician. 2012 Mar;58(3):257-67, e128-40
pubmed: 22518895
Brain Stimul. 2017 Nov - Dec;10(6):1133-1135
pubmed: 28923502
Arch Rehabil Res Clin Transl. 2019 Sep 27;1(3-4):100026
pubmed: 33543056
Pain. 2004 Mar;108(1-2):36-42
pubmed: 15109505
Arch Phys Med Rehabil. 2007 Aug;88(8):1049-54
pubmed: 17678669
Br J Sports Med. 2013 Jan;47(1):15-26
pubmed: 23243113
Neuromodulation. 2014 Aug;17(6):551-70; discussion 570
pubmed: 25112890
JAMA. 1999 Sep 8;282(10):954-7
pubmed: 10485680
Neurology. 2013 Feb 19;80(8):697-704
pubmed: 23390177
Brain Connect. 2011;1(3):255-65
pubmed: 22433053
Anesthesiology. 1999 Nov;91(5):1232-8
pubmed: 10551571
Sci Rep. 2017 Jul 28;7(1):6792
pubmed: 28754973
J Neurotrauma. 2007 Sep;24(9):1417-24
pubmed: 17892404
J Clin Neurol. 2011 Dec;7(4):184-96
pubmed: 22259614
J Vestib Res. 2007;17(2-3):119-30
pubmed: 18413905
J Neuroeng Rehabil. 2019 May 27;16(1):60
pubmed: 31133021
Int J Environ Res Public Health. 2017 Nov 13;14(11):
pubmed: 29137197
Cephalalgia. 2018 Apr;38(5):959-969
pubmed: 29231763
Arch Phys Med Rehabil. 2004 Oct;85(10):1662-6
pubmed: 15468028
Handb Clin Neurol. 2015;127:131-56
pubmed: 25702214
Cerebellum Ataxias. 2018 Mar 05;5:6
pubmed: 29556411
Neuroimage. 2011 Jun 15;56(4):2129-37
pubmed: 21496490