This study will investigate the potential value of CFX treatment, by prospective monitoring of functioning in patients that undergo this treatment. Likewise, aspects of the treatment that are important for patient experience will be systematically…
ID
Source
Brief title
Condition
- Structural brain disorders
Health condition
Concussion; Mild traumatic brain injury
Research involving
Sponsors and support
Intervention
- Other intervention
Outcome measures
Primary outcome
- Quantitative change in functioning on questionnaires and multidisciplinary assessment
Secondary outcome
- Qualitative change in functioning of patients (questionnaires and in-depth interview) - Identification of treatment aspects important for patient experience (in-depth interview) - Aetiology of potential change in recovery effects (re-analysis of existing clinical brain scans that will be requested at CFX)
Background summary
Worldwide, an estimated 54-60 million individuals sustain traumatic brain injury (TBI) annually. Mild TBI (or concussion) represents 90% of TBIs. Concussion can cause a wide range of symptoms that typically recover within weeks. However, approximately 10-30% of cases develop persistent symptoms beyond three months post-injury (~7,000 – 21,000 Dutch individuals), causing severe reduction in societal participation. Currently, there are no evidence-based treatments under the Dutch Health Care Insurance that aim to cure persistent symptoms. Recently, there has been a surge in attention from Dutch patients for a specific concussion clinic, Cognitive FX (CFX, Utah, USA). Thanks to promising patient experiences that circulate on social media, 200-300 Dutch patients travel to Utah yearly for ‘Enhanced Performance in Cognition’ (EPIC) treatment. However, effectiveness remains unclear from an evidence-based point of view. This pilot study will investigate the value of EPIC treatment in two work packages. The exploratory work package will systematically explore the content of the treatment, justification by CFX experts and patient experience. In addition, an inventory of potential working mechanisms will be made by a panel of independent experts. The quantitative work package will objectively determine short-term and longer-term functional change in relevant domains and statistically explore factors in recovery. Thereby, this study will provide better understanding for clinicians, facilitate patients in better informed decisions and indicate the need for follow-up research to researchers, policy makers and health care insurance providers.
Study objective
This study will investigate the potential value of CFX treatment, by prospective monitoring of functioning in patients that undergo this treatment. Likewise, aspects of the treatment that are important for patient experience will be systematically explored. Furthermore, this study aims to provide better understanding of the aetiology of potential recovery effects (with re-use of existing clinical brain scans). The results of this study will be reported in open-access summaries and published in peer-reviewed journals. Thereby, this study will provide better understanding for clinicians, facilitate patients in better informed decisions and indicate the need for follow-up research to researchers, policy makers and health care insurance providers.
Study design
This study has a quantitative approach with a prospective longitudinal observational design. In addition, a qualitative approach will be applied for a subsample of patients (n = 15) using in-depth interviews.
Age
Inclusion criteria
- Aged between 18 and 60 years - Sustained a concussion, defined as mild TBI (Glasgow Coma Scale score 15-13, loss of consciousness duration < 30 minutes, post-traumatic amnesia duration < 24 hours) without known intracranial pathology on neuroimaging (if available). - Persistent symptoms of concussion - At least 12 months post-injury - Scheduled for CFX treatment in the (near) future
Exclusion criteria
- History of psychiatric or neurological condition (other than concussion)
Design
Recruitment
IPD sharing statement
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9786 |
CCMO | NL76945.018.21 |
OMON | NL-OMON52204 |