*Appraising CFX Treatment for Concussion*

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 CFX treatment. This situation is problematic from a
societal point of view, since (1) very little is known about the content and
potential working mechanisms of the treatment, (2) the treatment is costly
(11-15 k¤) and therefore only available to a small part of the population; and
(3) effectiveness remains unclear from an evidence-based point of view.

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.

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.

Burden
Patients (N = 66) will:
(1) Fill out an online intake questionnaire (once, after inclusion) with an
expected total duration of 60 minutes);
(2) Fill out online monitoring questionnaires (four time points, at T0 = before
treatment, T1 = directly after treatment, T2 = in the month after treatment and
T3 = at follow-up) with an expected total duration of 185 minutes all together;
(3) Visit the research location to undergo multidisciplinary assessment (at T0,
T2 and T3). The multidisciplinary assessment will have a maximum duration of 3
hours per visit, with a total duration of 9 hours for all assessments.
(4) In-depth interview (60 minutes) will be performed (once, at T1) with a
subsample of patients (n = 15).

Thereby, total duration of study participation is (60 minutes + 185 minutes + 9
hours ~ ) 13 hours (excluding travel time) spread over a time frame of 7
months. For the subgroup of 15 patients that also participate in the interview,
total duration of study participation is (13 + 1 =) 14 hours.

Risks
The risks of participating in this observational study are considered
negligible.

Benefit
Patients do not have direct benefit of participation.

Group-relatedness
Patients in the study sample are adults with persisting symptoms of concussion.
These patients may have limitations in their tolerance for physical and/or
cognitive strain. This is inherent to the target population. Patients have the
possibility to complete the online questionnaires at own pace (e.g. in parts
spread over several days) and the assessment scheme during visits will be
customized in continuous consultation with the participant (e.g. with regard to
planning of breaks).