The REMIND Study- SPARK Neuro Software Study

Last updated: August 12, 2025
Sponsor: Spark Neuro Inc.
Overall Status: Completed

Phase

N/A

Condition

Learning Disorders

Dementia

Memory Loss

Treatment

SPARK Test

Clinical Study ID

NCT05406778
1001
  • Ages 55-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 55 to 85 at the time of consent

  2. Informant available and willing (remotely or in-person) to provide information aboutsleep patterns and cognitive functioning who spends >8 hours per week with primarysubject

  3. Subject or Legally Authorized Representative (LAR) has the ability to provideinformed consent and comply with the protocol.

Exclusion

Exclusion Criteria:

  1. Unable to remain still for up to 30 minutes during EEG data recording

  2. Subjects currently on and unable to wash out concomitant medications, including: 1)opiates; 2) benzodiazepines and nonbenzodiazepine hypnotics; 3) sedativeantihistamines; 4) tricyclic anti-depressants; 5) skeletal muscle relaxants; 6)antiepileptics; 7) antipsychotics; 8) antimanic agents; 9) THC; 10) anticholinergics

  3. Previous history of craniotomy

  4. Medical or psychiatric illness that would interfere with study participation

  5. History of epilepsy or chronic seizure disorder

  6. Presence of non-dental metal in head

  7. Currently experiencing a skin disease on scalp that would affect electrode contacts

  8. Subject meets at least one of the following criteria:

  9. Diagnosis of cognitive impairment from various underlying pathologies asindicated by one of the diagnostic codes listed in Appendix A (protocol)

  10. MMSE score of 27 or less

  11. Treating physician or PI have documented that the patient is cognitivelyimpaired, with judgment of cognitive impairment having been made within the 6months prior to enrollment

  12. Substance Use Disorder, including Alcohol

Study Design

Total Participants: 185
Treatment Group(s): 1
Primary Treatment: SPARK Test
Phase:
Study Start date:
May 18, 2022
Estimated Completion Date:
January 19, 2024

Study Description

The aim of this study is to collect data to support development of an algorithm to determine whether applying machine-learning techniques to eyes open/eyes closed resting-state electroencephalography (EEG) can characterize patient's cognitive status and detect the presence or absence of AD on the basis of the patient's EEG.

Connect with a study center

  • Voyage Medical

    Tempe, Arizona 85282
    United States

    Site Not Available

  • Island Psych

    Loma Linda, California 92318
    United States

    Site Not Available

  • CenExel Rocky Mountain

    Englewood, Colorado 80110
    United States

    Site Not Available

  • Renstar Medical

    Ocala, Florida 34470
    United States

    Site Not Available

  • Arcturus Healthcare PLC, Troy - Internal Medicine Division

    Troy, Michigan 48083
    United States

    Site Not Available

  • Alivation Health

    Lincoln, Nebraska 68501
    United States

    Site Not Available

  • Advanced Neuro

    El Paso, Texas 79835
    United States

    Site Not Available

  • Integrated Neurology

    Falls Church, Virginia 22040
    United States

    Site Not Available

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