Traumatic Brain Injury (TBI) Clinical Trial
— ABSOfficial title:
Modified Environment for Agitation in Patients With Traumatic Brain Injury: a Controlled Multicenter
NCT number | NCT02524067 |
Other study ID # | ABS project |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | May 2018 |
Verified date | September 2016 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study examines the effect of an intervention consisting of dynamic circadian light and sound therapy, as well as systematic information on sleep pattern, agitated behavior and functioning level.
Status | Completed |
Enrollment | 20 |
Est. completion date | May 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with moderate and severe Traumatic Brain Injury (TBI) - Diagnosed with Glasgow Coma Score (GCS) lower than 13- Exclusion Criteria: - Patients with psychiatric diagnose and not speaking danish - |
Country | Name | City | State |
---|---|---|---|
Denmark | Leanne Langhorn | Aarhus | Region Midt |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital, Glostrup University Hospital, Copenhagen, Regionshospitalet Hammel Neurocenter, Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agitation on Agitated Behaviour Scale (ABS) | One year | ||
Primary | Functional abilities on the Early Functional Abilities Scale (EFA) | One year | ||
Primary | Functional abilities on the Glasgow Outcome Extend Scale | 12 month after admission | ||
Secondary | Orientation and duration of post-traumatic amnesia on the Galveston Orientation and Amnesia Scale (GOAT) | One year |
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