COMPLETED

The REMIND Study- SPARK Neuro Software Study

Conditions

Alzheimer Disease Cognitive Impairment EEG Electroencephalography Machine learning

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

SPARK Neuro Quantitative Resting State EEG Protocol for Assessing Cognitive Impairment and Alzheimer's Disease Status- The REMIND Study

Quick Facts

Study Start:2022-05-18

Study Completion:2024-01-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05406778

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 55 to 85 at the time of consent 2. 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 3. Subject or Legally Authorized Representative (LAR) has the ability to provide informed consent and comply with the protocol.	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) sedative antihistamines; 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: 1. Diagnosis of cognitive impairment from various underlying pathologies as indicated by one of the diagnostic codes listed in Appendix A (protocol) 2. MMSE score of 27 or less 3. 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 9. Substance Use Disorder, including Alcohol

Inclusion Criteria

Exclusion Criteria

1. Age 55 to 85 at the time of consent
2. 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
3. Subject or Legally Authorized Representative (LAR) has the ability to provide informed consent and comply with the protocol.

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) sedative antihistamines; 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:
1. Diagnosis of cognitive impairment from various underlying pathologies as indicated by one of the diagnostic codes listed in Appendix A (protocol)
2. MMSE score of 27 or less
3. 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
9. Substance Use Disorder, including Alcohol

Contacts and Locations

Study Locations (Sites)

Island Psych

Loma Linda, California, 92318

United States

CenExel Rocky Mountain

Englewood, Colorado, 80110

United States

Renstar Medical

Ocala, Florida, 34470

United States

Arcturus Healthcare PLC, Troy - Internal Medicine Division

Troy, Michigan, 48083

United States

Alivation Health

Lincoln, Nebraska, 68501

United States

Advanced Neuro

El Paso, Texas, 79835

United States

Integrated Neurology

Falls Church, Virginia, 22040

United States

Collaborators and Investigators

Sponsor: Spark Neuro Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-18

Study Completion Date2024-01-19

Study Record Updates

Study Start Date2022-05-18

Study Completion Date2024-01-19

Terms related to this study

Keywords Provided by Researchers

EEG
Electroencephalography
Machine learning

Additional Relevant MeSH Terms

Alzheimer Disease
Cognitive Impairment