The REMIND Study- SPARK Neuro Software Study

NCT05406778 | Completed FDA Device

• 1 other identifier: 1001
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 7

Brief Summary

The study utilizes investigational software, the SPARK Test, with an FDA-cleared electroencephalography (EEG) amplifier and EEG cap to collect and patient EEG data.

Conditions

Alzheimer Disease; Cognitive Impairment

Keywords

EEG; Electroencephalography; Machine learning

Outcome Measures

Primary Outcomes (1)

• EEG Data collection for AI software development

  Rate of complete software collection per enrolled subjects complete a SPARK Test recording.

  During the diagnostic procedure

Study Arms (1)

Subjects - Variable Cognitive Status

OTHER

Subjects meeting Inclusion/Exclusion criteria with open eyes/closed eyes EEG collection.

Device: SPARK Test

Interventions

SPARK Test DEVICE

Thirty (30) minutes of resting state EEG data collection.

Subjects - Variable Cognitive Status

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 to 85 at the time of consent
• Informant available and willing (remotely or in-person) to provide information about sleep patterns and cognitive functioning who spends \>8 hours per week with primary subject
• Subject or Legally Authorized Representative (LAR) has the ability to provide informed consent and comply with the protocol.

You may not qualify if:

• Unable to remain still for up to 30 minutes during EEG data recording
• Subjects currently on and unable to wash out concomitant medications, including: 1) opiates; 2) benzodiazepines and nonbenzodiazepine hypnotics; 3) sedative antihistamines; 4) tricyclic anti-depressants; 5) skeletal muscle relaxants; 6) antiepileptics; 7) antipsychotics; 8) antimanic agents; 9) THC; 10) anticholinergics
• Previous history of craniotomy
• Medical or psychiatric illness that would interfere with study participation
• History of epilepsy or chronic seizure disorder
• Presence of non-dental metal in head
• Currently experiencing a skin disease on scalp that would affect electrode contacts
• Subject meets at least one of the following criteria:
• Diagnosis of cognitive impairment from various underlying pathologies as indicated by one of the diagnostic codes listed in Appendix A (protocol)
• MMSE score of 27 or less
• Treating physician or PI have documented that the patient is cognitively impaired, with judgment of cognitive impairment having been made within the 6 months prior to enrollment
• Substance Use Disorder, including Alcohol

Sponsors & Collaborators

• Spark Neuro Inc.: lead

Study Sites (7)

Island Psych

Loma Linda, California, 92318, United States

Location

CenExel Rocky Mountain

Englewood, Colorado, 80110, United States

Location

Renstar Medical

Ocala, Florida, 34470, United States

Location

Arcturus Healthcare PLC, Troy - Internal Medicine Division

Troy, Michigan, 48083, United States

Location

Alivation Health

Lincoln, Nebraska, 68501, United States

Location

Advanced Neuro

El Paso, Texas, 79835, United States

Location

Integrated Neurology

Falls Church, Virginia, 22040, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 6, 2022
• Study Start: May 18, 2022
• Primary Completion: August 24, 2023
• Study Completion: January 19, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)