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Software

SPARK Test for Cognitive Impairment

N/A
Recruiting
Research Sponsored by Spark Neuro Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
History of epilepsy or chronic seizure disorder
Currently experiencing a skin disease on scalp that would affect electrode contacts
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial uses a software to study patients' brainwaves to see if it's effective.

Who is the study for?
The SPARK Neuro REMIND Study is for individuals aged 55 to 85 with cognitive impairment or Alzheimer's, who have someone willing to report on their sleep and cognition. Participants must be able to consent and follow the study protocol. Exclusions include inability to stay still for EEG, certain medical conditions, substance use disorders, and specific medications.
What is being tested?
This trial tests the SPARK Test software used alongside an FDA-cleared EEG system. It aims to collect and analyze brain activity data (EEG) from participants in order to understand cognitive impairments better.
What are the potential side effects?
Since this study involves non-invasive EEG recording with no medication involved, side effects are minimal but may include discomfort from wearing the EEG cap or sitting still during the test.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 55 and 85 years old.
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I have someone who can report on my sleep and thinking skills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have epilepsy or a long-term seizure disorder.
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I have a skin condition on my scalp that could interfere with medical equipment.
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I am currently taking medication that cannot be stopped, including painkillers, sleep aids, or mood stabilizers.
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I can't stay still for 30 minutes during a brain wave test.
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I have had a stroke, severe head injury, or surgery on my skull.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of patients SPARK Test data
Software malfunction occurrences
Secondary study objectives
Mean absolute error for specific cognitive assessment
Other study objectives
Alzheimer's Disease positive vs. negative indication for biomarker-confirmed AD

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TBDExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Spark Neuro Inc.Lead Sponsor
2 Previous Clinical Trials
72 Total Patients Enrolled

Media Library

SPARK Test (Software) Clinical Trial Eligibility Overview. Trial Name: NCT05406778 — N/A
Alzheimer's Disease Research Study Groups: TBD
Alzheimer's Disease Clinical Trial 2023: SPARK Test Highlights & Side Effects. Trial Name: NCT05406778 — N/A
SPARK Test (Software) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05406778 — N/A
~114 spots leftby May 2025
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