Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT02849002
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 13 years old and not part of any other vulnerable population such as pregnant women.
2. Suspected or confirmed concussion by medical professional
3. Not more than 3 days since injury/trauma event
4. Willing and able to participate in all required study evaluations and allow access to medical testing and records
5. Signed informed consent/assent, and/or have a legally authorized representative willing to provide informed consent on behalf of the subject.
6. 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'
Exclusion Criteria:
1. Wound or open laceration on the head in the area of one of the BrainPulse sensors that would impede use of the BrainPulse device
2. Any serious medical condition that in the opinion of the medical professional would impair ability to provide informed consent/assent or otherwise disqualify a patient from participation
3. Currently participating in or planning to participate in another clinical study during the course of the current clinical study.
4. Implantation of any medical device in head (e.g. ventriculoperitoneal shunt)
5. An alternative diagnosis is made other than concussion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT02849002
Study Brief:
Protocol Section:
NCT02849002