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Diagnostic Device

BrainPulse for Concussion

N/A
Waitlist Available
Led By Neilank Jha, MD
Research Sponsored by Jan Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Demonstrates a minimum of 3 of the following symptoms: Headache, Pressure in head, Dizziness, Neck pain, Fatigue/ low energy, Nausea or vomiting, Irritability, Difficulty in concentrating/performing tasks, Memory impairment, Insomnia, Reduced tolerance to stress, Sensitivity to light, Difficulty balancing, Blurred vision, Confusion, More emotional than usual, Sadness, Nervous/Anxious, Vacant stare, Delayed verbal/motor response, 'Feeling like in a fog', 'Don't feel right'
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, expected to be 1 year]
Awards & highlights

Study Summary

This trial is to help improve a concussion detection algorithm by collecting recordings from people with concussions. The subjects will be followed for 21 days to study recovery.

Eligible Conditions
  • Concussion

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have at least three of the following symptoms - headache, dizziness, fatigue, nausea, sensitivity to light, difficulty in concentrating or balancing, blurred vision, confusion or feeling more emotional than usual.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, expected to be 1 year]
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, expected to be 1 year] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of BrainPulse recordings from suspected and confirmed concussed subjects
Secondary outcome measures
Average number of days the signal pattern seen within BrainPulse recordings from confirmed concussed subjects from the initial recording persist over the course of the 21 day follow up period.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Interventional DeviceExperimental Treatment1 Intervention
The BrainPulse is used on a patient's head to non-invasively detect, amplify and capture the brain motion caused by pulsatile blood flow from the cardiac cycle. The BrainPulse consists of a reusable headset that contains the accelerometers used to measure motion caused by pulsatile blood flow. The system is powered by rechargeable battery pack. The headset is placed on the subject's head and outputs data to a data collector that forwards the data to the computer. Each accelerometer has an attached tip that makes contact with the subject's head through hair. The headset also includes a photoplethysmograph (PPG) that simultaneously captures the subject's heart-rate information. There is no energy delivered to the brain or subject by these highly sensitive sensors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BrainPulse
2016
N/A
~760

Find a Location

Who is running the clinical trial?

Jan Medical, Inc.Lead Sponsor
11 Previous Clinical Trials
1,453 Total Patients Enrolled
Neilank Jha, MDPrincipal InvestigatorKonkussion

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available enrolment slots for the research trial?

"This clinical trial is no longer recruiting participants, as indicated on the clinicaltrials.gov website; it was initially posted in July 2016 and last updated August 29th of that year. However, there are presently 336 other trials actively seeking patients for participation."

Answered by AI
~3 spots leftby Mar 2025