Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia

Dementia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059877
• Other study ID #: QMF-MID12610
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: February 2012

Study information

• Verified date: August 2018
• Source: Quietmind Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dementia

Intervention

Device:
• 1072nm infrared Photobiomodulation
1072nm infrared light delivering 2.6 Joules (2.6J)/sq cm over a 6 minute treatment period.
• Photobiomodulation SIMULATED
Device mounted and procedure followed but with no stimulation.

Locations

Country	Name	City	State
United States	Quietmind Foundation	Plymouth Meeting	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Quietmind Foundation	Maculume Limited

Country where clinical trial is conducted

United States, 

References & Publications (1)

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). pii: 176. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall.	Delayed Word Recall is a subscale of the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog), a measure of cognitive impairment. Higher scores indicate greater impairment. Range: 0-10. Measures were taken within 72 hours of the first day of treatment and within 72 hours following the 28th day of treatment. Outcome measure was calculated by subtracting pretest from post test ADAS-Cog measurements.	Post-tx (total intervention period = 28 days) scores to be compared to baseline scores.