Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocol
Abstract Background Photobiomodulation using low-level laser therapy (LLLT) has been tested as a new technique to optimize recovery of patients with traumatic brain injury (TBI). The aim of this study is to evaluate inhibitory attentional control after 18 sessions of active LLLT and compare with the...
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| Format: | Article |
| Language: | English |
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BMC
2018-01-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2414-5 |
| _version_ | 1828276596789739520 |
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| author | Guilherme da Cruz Ribeiro Poiani Ana Luiza Zaninotto Ana Maria Costa Carneiro Renato Amaro Zangaro Afonso Shiguemi Inoue Salgado Rodolfo Borges Parreira Almir Ferreira de Andrade Manoel Jacobsen Teixeira Wellingson Silva Paiva |
| author_facet | Guilherme da Cruz Ribeiro Poiani Ana Luiza Zaninotto Ana Maria Costa Carneiro Renato Amaro Zangaro Afonso Shiguemi Inoue Salgado Rodolfo Borges Parreira Almir Ferreira de Andrade Manoel Jacobsen Teixeira Wellingson Silva Paiva |
| author_sort | Guilherme da Cruz Ribeiro Poiani |
| collection | DOAJ |
| description | Abstract Background Photobiomodulation using low-level laser therapy (LLLT) has been tested as a new technique to optimize recovery of patients with traumatic brain injury (TBI). The aim of this study is to evaluate inhibitory attentional control after 18 sessions of active LLLT and compare with the placebo group (sham LLLT). Our exploratory analysis will evaluate the efficacy of the active LLLT on verbal and visuospatial episodic memory, executive functions (working memory, verbal and visuospatial fluency, attentional processes), and anxiety and depressive symptoms compared to the sham group. Methods/Design A randomized double-blinded trial will be made in 36 patients with moderate and severe TBI. The active LLLT will use an optical device composed of LEDs emitting 632 nm of radiation at the site with full potency of 830 mW. The cranial region with an area of 400 cm2 will be irradiated for 30 min, giving a total dose per session of 3.74 J/cm2. The sham LLLT group contains only an LED device with power < 1 mW, only serving to simulate the irradiation. Each patient will be irradiated three times per week for six weeks, totaling 18 sessions. Neuropsychological assessments will be held one week before the beginning of the sessions, after one week, and three months after the end of LLLT sessions. Memory domain, attention, executive functioning, and visual construction will be evaluated, in addition to symptoms of depression, anxiety, and social demographics. Discussion LLLT has been demonstrated as a safe and effective technique in significantly improving the memory, attention, and mood performance in healthy and neurologic patients. We expect that our trial can complement previous finds, as an effective low-cost therapy to improve cognitive sequel after TBI. Trial registration ClinicalTrials.gov, NCT02393079 . Registered on 20 February 2015. |
| first_indexed | 2024-04-13T06:59:36Z |
| format | Article |
| id | doaj.art-444c87899c8846e99753c7ad0c452aa4 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T06:59:36Z |
| publishDate | 2018-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-444c87899c8846e99753c7ad0c452aa42022-12-22T02:57:08ZengBMCTrials1745-62152018-01-011911810.1186/s13063-017-2414-5Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocolGuilherme da Cruz Ribeiro Poiani0Ana Luiza Zaninotto1Ana Maria Costa Carneiro2Renato Amaro Zangaro3Afonso Shiguemi Inoue Salgado4Rodolfo Borges Parreira5Almir Ferreira de Andrade6Manoel Jacobsen Teixeira7Wellingson Silva Paiva8Division of Neurosurgery, University of Sao Paulo Medical SchoolDivision of Psychology at Hospital of Clinics, University of Sao Paulo Medical SchoolInstitute of Biomedical Engineering, Anhembi Morumbi UniversityInstitute of Biomedical Engineering, Anhembi Morumbi UniversitySalgado Institute of Integral Health; School of Postural and Manual TherapySalgado Institute of Integral Health; School of Postural and Manual TherapyDivision of Neurosurgery, University of Sao Paulo Medical SchoolDivision of Neurosurgery, University of Sao Paulo Medical SchoolDivision of Neurosurgery, University of Sao Paulo Medical SchoolAbstract Background Photobiomodulation using low-level laser therapy (LLLT) has been tested as a new technique to optimize recovery of patients with traumatic brain injury (TBI). The aim of this study is to evaluate inhibitory attentional control after 18 sessions of active LLLT and compare with the placebo group (sham LLLT). Our exploratory analysis will evaluate the efficacy of the active LLLT on verbal and visuospatial episodic memory, executive functions (working memory, verbal and visuospatial fluency, attentional processes), and anxiety and depressive symptoms compared to the sham group. Methods/Design A randomized double-blinded trial will be made in 36 patients with moderate and severe TBI. The active LLLT will use an optical device composed of LEDs emitting 632 nm of radiation at the site with full potency of 830 mW. The cranial region with an area of 400 cm2 will be irradiated for 30 min, giving a total dose per session of 3.74 J/cm2. The sham LLLT group contains only an LED device with power < 1 mW, only serving to simulate the irradiation. Each patient will be irradiated three times per week for six weeks, totaling 18 sessions. Neuropsychological assessments will be held one week before the beginning of the sessions, after one week, and three months after the end of LLLT sessions. Memory domain, attention, executive functioning, and visual construction will be evaluated, in addition to symptoms of depression, anxiety, and social demographics. Discussion LLLT has been demonstrated as a safe and effective technique in significantly improving the memory, attention, and mood performance in healthy and neurologic patients. We expect that our trial can complement previous finds, as an effective low-cost therapy to improve cognitive sequel after TBI. Trial registration ClinicalTrials.gov, NCT02393079 . Registered on 20 February 2015.http://link.springer.com/article/10.1186/s13063-017-2414-5Traumatic brain injuryCognitionMemoryDepressionAnxietyPhotobiomodulation |
| spellingShingle | Guilherme da Cruz Ribeiro Poiani Ana Luiza Zaninotto Ana Maria Costa Carneiro Renato Amaro Zangaro Afonso Shiguemi Inoue Salgado Rodolfo Borges Parreira Almir Ferreira de Andrade Manoel Jacobsen Teixeira Wellingson Silva Paiva Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocol Trials Traumatic brain injury Cognition Memory Depression Anxiety Photobiomodulation |
| title | Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocol |
| title_full | Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocol |
| title_fullStr | Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocol |
| title_full_unstemmed | Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocol |
| title_short | Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocol |
| title_sort | photobiomodulation using low level laser therapy lllt for patients with chronic traumatic brain injury a randomized controlled trial study protocol |
| topic | Traumatic brain injury Cognition Memory Depression Anxiety Photobiomodulation |
| url | http://link.springer.com/article/10.1186/s13063-017-2414-5 |
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