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New treatment option for Concussion Post Syndrome
Official title Auditory Slow Wave Enhancement After Concussion
ClinicalTrials.gov ID: NCT04770116
What this study is testing
- What it's testing
- The prevalence of a traumatic brain injury (TBI) in children and adolescents is around 30% with 70-90% being classified as mild (concussion). Because the brain of a child is still developing, a TBI can have devastating effects and possibly creates lifetime challenges.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18. Healthy volunteers may be eligible.
You may be able to join if
- Informed Consent as documented by signature
- Age between 6 and 18 years
- Good knowledge of German of the patient and at least one legal representative
- Patients: Presentation to the Emergency of the University Children's Hospital Zurich because of a concussion (diagnosed by medical doctor)
You likely can't join if
- Preterm birth (\< 37 gestational weeks)
- Diagnosed hearing disorder
- Psychiatric, syndromal, or neurological pre-existing condition (except for previous concussion)
- Skin disorder/skin problem in the face/ear area that requires Treatment
- Usage of neuroactive substances
- Patients: Concomitant injury that requires intense pain medication or a prolonged hospital stay, or that causes limited use of the dominant Hand
See the full eligibility criteria
- Informed Consent as documented by signature
- Age between 6 and 18 years
- Good knowledge of German of the patient and at least one legal representative
- Patients: Presentation to the Emergency of the University Children's Hospital Zurich because of a concussion (diagnosed by medical doctor)
- Preterm birth (\< 37 gestational weeks)
- Diagnosed hearing disorder
- Psychiatric, syndromal, or neurological pre-existing condition (except for previous concussion)
- Skin disorder/skin problem in the face/ear area that requires Treatment
- Usage of neuroactive substances
- Patients: Concomitant injury that requires intense pain medication or a prolonged hospital stay, or that causes limited use of the dominant Hand
- Patients: Previous moderate-severe TBI
- Controls: Injury of the dominant hand, on head, arm, or leg
- Controls: Previous TBI (of any severity) Additional inclusion criteria for the optional MRI measurement for both groups:
- Age at least 8 years
- Fulfilment of all MRI safety criteria
- The participant and the legal representative would want to know about incidental findings.
- Girls: No pregnancy or breast feeding.
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 18 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.