Photobiomodulation for Improving Brain Function in Dementia (PBM Dementia)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 9/30/2018 |
| Start Date: | May 15, 2017 |
| End Date: | November 30, 2019 |
Examining the Impact of Photobiomodulation (PBM) on Brain Function in Dementia
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, p<0.003) and Alzheimer's Disease Assessment Scale-cognitive,
ADAS-cog, p<0.03). 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.
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, p<0.003) and Alzheimer's Disease Assessment Scale-cognitive,
ADAS-cog, p<0.03). 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.
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 (i.e., 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< 0.003) and Alzheimer's Disease Assessment
Scale-cognitive subscale (ADAS-cog, p< 0.03) 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 Alzheimer's 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 (i.e., 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 (e.g., 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
(e.g., 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.
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 (i.e., 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< 0.003) and Alzheimer's Disease Assessment
Scale-cognitive subscale (ADAS-cog, p< 0.03) 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 Alzheimer's 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 (i.e., 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 (e.g., 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
(e.g., 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.
Inclusion Criteria:
For primary study participants (i.e., individuals with dementia):
age > 50 years a diagnosis of dementia (preferably AD) by their neurologist English
language fluency, legally authorized representative consent no contraindications for MRI
MMSE > 11
Inclusion criteria for caregivers:
current provision of care to primary participant with dementia ability to answer questions
about the primary participant's behaviors, quality of life, and their own level of stress.
Exclusion Criteria:
For primary study participants (i.e., individuals with dementia):
lack of assent to study procedures contraindications for MRI (i.e., pacemakers, metal
implants, claustrophobia) terminal illness (i.e., life expectancy < 1 year) started
dementia medication (i.e., cholinesterase inhibitor or memantine) in the past 3 months or
planning to start new dementia medication current participation in another research study
that could potentially confound current study (e.g., medication or behavioral intervention)
MMSE < 11.
Exclusion criteria for caregivers:
major neurological or psychiatric condition terminal illness evidence of cognitive
impairment inability to consent to study procedures
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