Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03160027
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2017-05-16
Brief Title:
Photobiomodulation for Improving Brain Function in Dementia PBM Dementia
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Examining the Impact of Photobiomodulation PBM on Brain Function in Dementia
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PBM Dementia
Brief Summary:
A recent study Saltmarche et al 21017 examined the effects of photobiomodulation PBM a kind of light therapy that uses red or near-infrared light to heal and protect tissue that has either been injured is degenerating or else is at risk of dying in 5 older adults with dementia After 12 weeks of PBM treatments delivered with a commercially available wearable device the patients with mild to moderately severe dementia showed improvements on the Mini-mental State Exam MMSE p0003 and Alzheimers Disease Assessment Scale-cognitive ADAS-cog p003 The caregivers who kept daily journals of their experiences during the 12 weeks of PBM treatment reported better sleep fewer angry outbursts decreased anxiety and wandering in their loved-ones with dementia The goals of this trial are to 1 replicate this finding in a larger group of individuals with dementia and 2 to examine the underling brain mechanisms behind the changes in cognitive function
Detailed Description:
Photobiomodulation PBM describes a kind of light therapy that uses red or near-infrared light to stimulate heal regenerate and protect tissue that has either been injured is degenerating or else is at risk of dying Human cadaver studies have shown near-infrared wavelengths can penetrate 40-50 mm through the scalp and skull Saltmarche et al 2017 recently reported that 12-weeks of transcranial treatment with a commercially available PBM device ie the Vielight Neuro benefits cognitive function in patients with mild-to-moderately severe dementia Specifically Saltmarche et al reported improvements on the Mini Mental State Examination MMSE p 0003 and Alzheimers Disease Assessment Scale-cognitive subscale ADAS-cog p 003 in 5 dementia patients after 12-weeks of PBM treatment
The first aim of this trial is to replicate Saltmarche et al s findings that the effects of 12-weeks of PBM treatment can improve cognitive function in older adults with dementia Because the Vielight Neuro device targets nodes of the default mode network DMN which is dysregulated in Alzheimers disease AD the second aim of this pilot study is to investigate whether 12 weeks of PBM therapy with the Vielight Neuro device improves DMN connectivity in older adults with dementia Finally because there is suggestive evidence that PBM therapy enhances blood flow the third aim of the trial is to examine whether 12-weeks of PBM therapy improves cerebral blood flow CBF in older adults with dementia The trial will also explore the effects of PBM treatment on quality of life in older adults with dementia and on caregiver burden
Ten older adults with dementia ie the primary study participants PP and their caregivers CG will be enrolled in a randomized wait-list control trial Five PPs will be randomized to the immediate PBM treatment group after the baseline psychometric and MRI assessments Five PP will be randomized to a delayed PBM treatment group that will not receive PBM treatment with the Vielight Neuro device until after the 12 week psychometric and MRI assessments
Neuroimaging measures will be assessed in all PPs at baseline and week 12 Cognitive function and quality of life will be assessed in all PPs at baseline weeks 6 and 12 Caregivers CGs will be asked to fill out questionnaires Caregivers CGs will be asked to fill out questionnaires about caregiver burden positive aspects of care giving depressive symptomology and dementia-related behaviors in the PP at baseline weeks 6 and 12
PPs randomized to the immediate PBM treatment group will receive PBM with the Vielight Neuro device once a day every other day eg Mon Wed Fri for 12 weeks PPs randomized to the delayed PBM treatment group will keep doing their usual activities for 12 weeks After the 12 week psychometric and MRI assessments PPs randomized to the delayed PBM treatment group will receive PBM with the Vielight Neuro device once a day every other day eg Mon Wed Fri for 12 weeks PPs randomized to the delayed PBM treatment group will undergo additional psychometric assessment at weeks 18 and 24 CGs of PPs randomized to the delayed PBM treatment group will be asked to fill out additional questionnaires about caregiver burden positive aspects of care giving depressive symptomology and dementia-related behaviors in the PP at baseline weeks 18 and 24
The first aim of this trial is to replicate Saltmarche et al s findings that the effects of 12-weeks of PBM treatment can improve cognitive function in older adults with dementia Because the Vielight Neuro device targets nodes of the default mode network DMN which is dysregulated in Alzheimers disease AD the second aim of this pilot study is to investigate whether 12 weeks of PBM therapy with the Vielight Neuro device improves DMN connectivity in older adults with dementia Finally because there is suggestive evidence that PBM therapy enhances blood flow the third aim of the trial is to examine whether 12-weeks of PBM therapy improves cerebral blood flow CBF in older adults with dementia The trial will also explore the effects of PBM treatment on quality of life in older adults with dementia and on caregiver burden
Ten older adults with dementia ie the primary study participants PP and their caregivers CG will be enrolled in a randomized wait-list control trial Five PPs will be randomized to the immediate PBM treatment group after the baseline psychometric and MRI assessments Five PP will be randomized to a delayed PBM treatment group that will not receive PBM treatment with the Vielight Neuro device until after the 12 week psychometric and MRI assessments
Neuroimaging measures will be assessed in all PPs at baseline and week 12 Cognitive function and quality of life will be assessed in all PPs at baseline weeks 6 and 12 Caregivers CGs will be asked to fill out questionnaires Caregivers CGs will be asked to fill out questionnaires about caregiver burden positive aspects of care giving depressive symptomology and dementia-related behaviors in the PP at baseline weeks 6 and 12
PPs randomized to the immediate PBM treatment group will receive PBM with the Vielight Neuro device once a day every other day eg Mon Wed Fri for 12 weeks PPs randomized to the delayed PBM treatment group will keep doing their usual activities for 12 weeks After the 12 week psychometric and MRI assessments PPs randomized to the delayed PBM treatment group will receive PBM with the Vielight Neuro device once a day every other day eg Mon Wed Fri for 12 weeks PPs randomized to the delayed PBM treatment group will undergo additional psychometric assessment at weeks 18 and 24 CGs of PPs randomized to the delayed PBM treatment group will be asked to fill out additional questionnaires about caregiver burden positive aspects of care giving depressive symptomology and dementia-related behaviors in the PP at baseline weeks 18 and 24
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None