Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia
Completed · Not applicable · Has a placebo group
Conditions studied: Dementia
In brief
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.
Key facts
- Study ID
- NCT01059877
- Run by
- Quietmind Foundation
- People needed
- 11
- Starts
- 2010-01-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2018-09-27
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.
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).
Where it is running
- Quietmind Foundation — Plymouth Meeting, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.