Protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with Parkinson’s disease
IntroductionParkinson’s disease (PD) is the second most common, progressive, and debilitating neurodegenerative disease associated with aging and the most common movement disorder. Photobiomodulation (PBM), the use of non-thermal light for therapeutic purposes using laser or light emitting diodes (L...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-08-01
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| Series: | Frontiers in Neuroscience |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fnins.2022.945796/full |
| _version_ | 1811321085888561152 |
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| author | Claire McGee Ann Liebert Ann Liebert Ann Liebert Geoffrey Herkes Geoffrey Herkes Brian Bicknell Vincent Pang Craig S. McLachlan Hosen Kiat Hosen Kiat Hosen Kiat Hosen Kiat |
| author_facet | Claire McGee Ann Liebert Ann Liebert Ann Liebert Geoffrey Herkes Geoffrey Herkes Brian Bicknell Vincent Pang Craig S. McLachlan Hosen Kiat Hosen Kiat Hosen Kiat Hosen Kiat |
| author_sort | Claire McGee |
| collection | DOAJ |
| description | IntroductionParkinson’s disease (PD) is the second most common, progressive, and debilitating neurodegenerative disease associated with aging and the most common movement disorder. Photobiomodulation (PBM), the use of non-thermal light for therapeutic purposes using laser or light emitting diodes (LED) is an emerging non-invasive treatment for a diverse range of neurological conditions. The main objectives of this clinical trial are to investigate the feasibility, safety, tolerability, and efficacy of a novel transcranial LED helmet device (the “PDNeuro”) in the alleviation of symptoms of PD.Methods and analysisThis is a 24-week, two-arm, triple-blinded randomized placebo-controlled clinical trial of a novel transcranial “PDNeuro” LED Helmet, comparing an active helmet to a sham helmet device. In a survey, 40 PD participants with Hoehn and Yahr Stage I–III during ON periods will be enrolled and randomly assigned into two groups. Both groups will be monitored weekly for the safety and tolerability of the “PDNeuro” LED Helmet. Clinical signs and symptoms assessed will include mobility, fine motor skills and cognition, with data collected at baseline, 12 weeks, and 24 weeks. Assessment tools include the TUG, UPDRS, and MoCA all validated for use in PD patients. Patient’s adherence to the device usage and participant drop out will be monitored weekly. At 12 weeks both placebo and treatment groups will crossover and placebo participants offered the treatment. The main indicator for clinical efficacy of the “PDneuro” Helmet is evidence of sustained improvements in motor and non-motor symptoms obtained from participant self-reported changes, carer reporting of changes and objective reassessment by the investigators. The outcomes will assist in a future larger randomized trial design.Clinical Trial Registration[https://www.anzctr.org.au], identifier [12621001722886]. |
| first_indexed | 2024-04-13T13:10:39Z |
| format | Article |
| id | doaj.art-4d7e12fe43ff46a188bbf628bb34dbdb |
| institution | Directory Open Access Journal |
| issn | 1662-453X |
| language | English |
| last_indexed | 2024-04-13T13:10:39Z |
| publishDate | 2022-08-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neuroscience |
| spelling | doaj.art-4d7e12fe43ff46a188bbf628bb34dbdb2022-12-22T02:45:37ZengFrontiers Media S.A.Frontiers in Neuroscience1662-453X2022-08-011610.3389/fnins.2022.945796945796Protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with Parkinson’s diseaseClaire McGee0Ann Liebert1Ann Liebert2Ann Liebert3Geoffrey Herkes4Geoffrey Herkes5Brian Bicknell6Vincent Pang7Craig S. McLachlan8Hosen Kiat9Hosen Kiat10Hosen Kiat11Hosen Kiat12Faculty of Health Sciences, Torrens University, Sydney, NSW, AustraliaSchool of Medical Sciences, University of Sydney, Camperdown, NSW, AustraliaDepartment of Research and Governance, San Hospital, Wahroonga, NSW, AustraliaNICM Health Research Institute, University of Western Sydney, Westmead, NSW, AustraliaDepartment of Neurology, San Hospital, Wahroonga, NSW, AustraliaAustralian National University, Canberra, ACT, AustraliaNICM Health Research Institute, University of Western Sydney, Westmead, NSW, AustraliaNICM Health Research Institute, University of Western Sydney, Westmead, NSW, AustraliaCentre for Healthy Futures, Torrens University, Sydney, NSW, AustraliaNICM Health Research Institute, University of Western Sydney, Westmead, NSW, AustraliaFaculty of Medicine, Human and Health Sciences, Macquarie University, Sydney, NSW, AustraliaCollege of Health and Medicine, Australian National University, Canberra, ACT, Australia0Cardiac Health Institute, Sydney, NSW, AustraliaIntroductionParkinson’s disease (PD) is the second most common, progressive, and debilitating neurodegenerative disease associated with aging and the most common movement disorder. Photobiomodulation (PBM), the use of non-thermal light for therapeutic purposes using laser or light emitting diodes (LED) is an emerging non-invasive treatment for a diverse range of neurological conditions. The main objectives of this clinical trial are to investigate the feasibility, safety, tolerability, and efficacy of a novel transcranial LED helmet device (the “PDNeuro”) in the alleviation of symptoms of PD.Methods and analysisThis is a 24-week, two-arm, triple-blinded randomized placebo-controlled clinical trial of a novel transcranial “PDNeuro” LED Helmet, comparing an active helmet to a sham helmet device. In a survey, 40 PD participants with Hoehn and Yahr Stage I–III during ON periods will be enrolled and randomly assigned into two groups. Both groups will be monitored weekly for the safety and tolerability of the “PDNeuro” LED Helmet. Clinical signs and symptoms assessed will include mobility, fine motor skills and cognition, with data collected at baseline, 12 weeks, and 24 weeks. Assessment tools include the TUG, UPDRS, and MoCA all validated for use in PD patients. Patient’s adherence to the device usage and participant drop out will be monitored weekly. At 12 weeks both placebo and treatment groups will crossover and placebo participants offered the treatment. The main indicator for clinical efficacy of the “PDneuro” Helmet is evidence of sustained improvements in motor and non-motor symptoms obtained from participant self-reported changes, carer reporting of changes and objective reassessment by the investigators. The outcomes will assist in a future larger randomized trial design.Clinical Trial Registration[https://www.anzctr.org.au], identifier [12621001722886].https://www.frontiersin.org/articles/10.3389/fnins.2022.945796/fullphotobiomodulationtranscranialParkinson’s diseasecognitive dysfunctionmobility |
| spellingShingle | Claire McGee Ann Liebert Ann Liebert Ann Liebert Geoffrey Herkes Geoffrey Herkes Brian Bicknell Vincent Pang Craig S. McLachlan Hosen Kiat Hosen Kiat Hosen Kiat Hosen Kiat Protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with Parkinson’s disease Frontiers in Neuroscience photobiomodulation transcranial Parkinson’s disease cognitive dysfunction mobility |
| title | Protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with Parkinson’s disease |
| title_full | Protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with Parkinson’s disease |
| title_fullStr | Protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with Parkinson’s disease |
| title_full_unstemmed | Protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with Parkinson’s disease |
| title_short | Protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with Parkinson’s disease |
| title_sort | protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with parkinson s disease |
| topic | photobiomodulation transcranial Parkinson’s disease cognitive dysfunction mobility |
| url | https://www.frontiersin.org/articles/10.3389/fnins.2022.945796/full |
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