NCT05642221Completed
Functional Near-Infrared Spectroscopy (fNIRS) Combined With Diffuse Correlation Spectroscopy (DCS) in Neurocognitive Disease as Compared to Healthy Neurotypical Controls
Pilot Study of the Use of Functional Near-Infrared Spectroscopy (fNIRS) Combined With Diffuse Correlation Spectroscopy (DCS) in Neurocognitive Disease as Compared to Healthy Neurotypical Controls
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
Background: Neurocognitive disorders affect how the brain uses oxygen. They may affect mental development in children. These disorders can be studied with imaging scans that use radiation; however, these methods are not ideal for research on children. Two technologies-functional near-infrared spectroscopy (fNIRS) and diffuse correlation spectroscopy (DCS)-use light to detect changes in brain activity. These methods are safer, and they can be used in a more relaxed setting. In this natural history study, researchers want to find out whether fNIRS and DCS can be a good way to study people with neurocognitive disorders. Objective: To find out whether fNIRS and DCS can be useful in measuring brain activity in people with neurocognitive disorders. Eligibility: People aged 6 months or older with neurocognitive disorders. These can include Niemann-Pick disease type C1 (NPC1); creatine transporter deficiency (CTD); Smith Lemli Opitz syndrome (SLOS); juvenile neuronal ceroid lipofuscinosis (CLN3 disease); and Pheland-McDermid (PMS) syndrome. Healthy volunteers are also needed. Design: Participants will have a physical exam. They will have tests of their memory and thinking. Participants will sit in a quiet room for the fNIRS and DCS tests. A snug cap (like a cloth swim cap) will be placed on their head. The cap has lights and sensors. Another sensor will be placed on their forehead. Participants will perform tasks on a computer. This testing will take 45 to 60 minutes. The tests will be repeated within 1 to 4 weeks. Participants will be asked to return for repeat tests 1 year later....
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 73 (actual)
- First submitted
- 7 Dec 2022
- Start date
- 23 Jan 2023
- Primary completion date
- 10 Oct 2024
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Diseases
- Frontotemporal dementia
- NCT number
- NCT05642221
What you commit to
- Study type: Observational
- Participants enrolled: 73
- From 23 Jan 2023 to the primary completion date, 10 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- For both study populations (Affected and Typically Developing group):
- Any condition that may affect placement of the fNIRS-DCS
- Past or present vascular disease
- Traumatic loss of consciousness in the last year
- Any condition which, in the opinion of the investigator, increases risk of participation or affects adherence to the protocol
- For controls (Typically Developing Group):
- Known or suspected cognitive impairment
- Known history of MRI abnormality
- Current use of psychotropic medications
Criteria the registry did not label
- INCLUSION CRITERIA:
- For both study populations (Affected and Typically Developing group):
- Male or female, aged 6 months and up
- English is the primary language spoken at home
- For study population (Affected group):
- --Neurocognitive-related conditions including SLOS, CLN3, CTD, NPC and PMS.
- For controls (Typically Developing Group):
- In good general health as determined by medical history and physical exam
Age in the registry: 6 months to 110 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.