Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia

NCT01059877 | Completed Results DMC

• 1 other identifier: QMF-MID12610
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

dementia alzheimers frontotemporal lyme,; lewy body cognitive impairment

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

1072nm Infrared Photobiomodulation

ACTIVE COMPARATOR

Received treatment for dementia with transcranial 1072nm infrared light stimulation.

Device: 1072nm infrared Photobiomodulation

Placebo

PLACEBO COMPARATOR

Placebo device simulated transcranial photobiomodulation

Device: Photobiomodulation SIMULATED

Interventions

1072nm infrared Photobiomodulation DEVICE

1072nm infrared light delivering 2.6 Joules (2.6J)/sq cm over a 6 minute treatment period.

Also known as: Photobiomodulation, Low-level LED Light Stimulation

1072nm Infrared Photobiomodulation

Photobiomodulation SIMULATED DEVICE

Device mounted and procedure followed but with no stimulation.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Quietmind Foundation: lead
• Maculume Ltd.: collaborator

Study Sites (1)

Quietmind Foundation

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Related 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):176. doi: 10.21767/2171-6625.1000176. Epub 2017 Feb 28.

  PMID: 28593105 RESULT

MeSH Terms

Conditions

Dementia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Marvin Berman, PhD
• Organization: QuietMind Foundation

marvinberman@quietmindfdn.org

610.940.0488

Study Officials

• Marvin H Berman, Ph.D

  Quietmind Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical trial coordinator

Model Details: Small placebo controlled randomized trial.

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: February 1, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: September 27, 2018
• Results First Posted: September 27, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)