Clinical trial NCT01059877: Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia
Official title: Assessing the Effect of 1072nm Infrared (IR) Phototherapy on the Behavioral and Cognitive Symptoms Associated With Early and Mid-stage Dementia: a Randomized Placebo-controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dementia alzheimers frontotemporal lyme,
lewy body cognitive impairment
Lead sponsor: Quietmind Foundation
Sponsor class: OTHER
Collaborators: name: Maculume Ltd.
First posted: 2010-02-01
Enrollment: 11
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Small placebo controlled randomized trial.
Primary purpose: TREATMENT

Brief summary: This study will employ a double-blind, placebo-controlled approach to assess the effect of 1072nm infrared (IR) phototherapy on the behavioral and cognitive symptoms associated with early and mid-stage dementia.

Detailed description: What hypotheses are you testing?

We are seeking to determine if the provision of brief, repeated exposure to 1072nm infrared stimulation of the cortex surface improves cognitive and behavioral functioning as indicated by normalization of EEG activity, increased cerebral oxygenation and demonstrated improvement on standardized neuropsychological measures.

Intensive near infrared stimulation has been shown to be effective in accelerating healing of injuries and functional modification including increasing blood flow and perfusion. Dementia research has suggested that hypoperfusion is a significant underlying mechanism in the progression of dementia. Infrared spectroscopy has been shown effective in the non-invasive measurement of changes in cerebral oxygenation and perfusion. This study therefore seeks to explore whether the increasing of regional cerebral perfusion and oxygenation using infrared light stimulation will result in improved cognitive and behavioral functioning.

Eligibility criteria: Inclusion Criteria:

* Aged between 50 - 85 years.
* Have established cognitive impairment, Mini Mental Status Examination (MMSE) score between 15- 25 (from a possible score of 30).
* Generally healthy otherwise as indicated by recent physical examination.
* Have a caregiver/informant who has cared for the patient at least 5 days a week and is willing to attend study visits and provide information about the patient.
* If taking any psychotropic medication should have been stable for the previous 3 months.
* Must have had B12, folic acid, full blood count and ferritin screen within the previous 6 months or be on B12 and/or folic acid replacement.

Exclusion Criteria:

* Uncontrolled or unstable chronic illness, e.g., hypertension, chronic obstructive pulmonary disease (COPD).
* Diagnosed actively growing intracranial pathology (tumors etc).
* An associated psychotic illness.
* Misusing illegal substances or alcohol.
* On regular systemic steroids or anti-metabolites.
* Systemic malignancies and/or space occupying lesions in the brain.
* Not fluent in English.
* Depressed as assessed by Beck Depression Inventory score.
* Epilepsy.
* Lacking the capacity to give informed consent.
* Previous history of stroke or heart attack.
* History of aggression or violence.
* Inability to travel to the research venue for multiple assessments.
* A history of major psychiatric illness, seizure disorder, or physical illness that would compromise their participation in a daily treatment regimen.
* A participant may be disqualified if their performance is above the normative mean or below the lowest interpretable score of neuropsychological tests provided during the initial assessment (see #6, Sources of research material obtained from study participants, below).

Primary outcomes:
measure: Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall.
timeFrame: Post-tx (total intervention period = 28 days) scores to be compared to baseline scores.
Secondary outcomes:
Other outcomes:
Locations:
city: Plymouth Meeting
country: United States
facility: Quietmind Foundation
state: Pennsylvania
Study officials:
affiliation: Quietmind Foundation
name: Marvin H Berman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berman MH, Halper JP, Nichols TW, Jarrett H, Lundy A, Huang JH. Photobiomodulation with Near Infrared Light Helmet in a Pilot, Placebo Controlled Clinical Trial in Dementia Patients Testing Memory and Cognition. J Neurol Neurosci. 2017;8(1):176. doi: 10.21767/2171-6625.1000176. Epub 2017 Feb 28.