Status:
RECRUITING
Auditory Slow Wave Enhancement After Concussion
Lead Sponsor:
University Children's Hospital, Zurich
Collaborating Sponsors:
ETH Zurich
University of Zurich
Conditions:
Concussion Post Syndrome
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
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 ca...
Detailed Description
In total, 120 participants are planned: 60 patients (30 intervention, 30 sham) and 60 controls (30 intervention, 30 sham). This was estimated from a power analysis and based on previous results. Patie...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04770116
Start Date
May 31 2021
End Date
March 31 2026
Last Update
December 9 2024
Active Locations (1)
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1
University Children's Hospital Zurich
Zurich, Switzerland, 8032