Appraising CFX Treatment for Concussion

*Appraising CFX Treatment for Concussion* - The ACTC Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52204

Enrollment

Registered

2021-05-17

Start date

2022-01-10

Completion date

Unknown

Last updated

2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Aged between 18 and 65 years, in order to confine the population to the adult range - Sustained a concussion, defined as mild TBI (Glasgow Coma Scale score 15-13, loss of consciousness duration

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - History of psychiatric or neurological condition (other than concussion)

Design outcomes

Primary

Measure	Time frame
- Quantitative change in functioning on questionnaires and multidisciplinary assessment The primary study parameters will be obtained based on dimensionality reduction methods (e.g. principal component analysis) to select a limited number of dependent variables from a broad range of measurements. The measurements in questionnaires relate to: - Global outcome (Glasgow Outcome Scale-Extended) - Symptoms of concussion (SCAT-5 symptom scale) - Participation (USER-Participation) - Anxiety and depression (Hospital Anxiety and Depression Scale) - Sleep Quality (Pittsburg Sleep Quality Index) - Quality of Life, partner relation, system support (custom questionnaire) Multidisciplinary assessment consists of: - Neurocognitive functioning (Emma Toolbox for Neurocognitive Functioning) - Eye-tracking (Sensomotoric Instruments RED 250) - Postural Control and Balance (Motek Dynstable) - Vestibular and Ocular functioning (Vestibular/OculoMotor Screening)	—

Measure

Time frame

- Quantitative change in functioning on questionnaires and multidisciplinary assessment The primary study parameters will be obtained based on dimensionality reduction methods (e.g. principal component analysis) to select a limited number of dependent variables from a broad range of measurements. The measurements in questionnaires relate to: - Global outcome (Glasgow Outcome Scale-Extended) - Symptoms of concussion (SCAT-5 symptom scale) - Participation (USER-Participation) - Anxiety and depression (Hospital Anxiety and Depression Scale) - Sleep Quality (Pittsburg Sleep Quality Index) - Quality of Life, partner relation, system support (custom questionnaire) Multidisciplinary assessment consists of: - Neurocognitive functioning (Emma Toolbox for Neurocognitive Functioning) - Eye-tracking (Sensomotoric Instruments RED 250) - Postural Control and Balance (Motek Dynstable) - Vestibular and Ocular functioning (Vestibular/OculoMotor Screening)

—

Secondary

Measure	Time frame
Secundary parameters relate to: - Qualitative change in functioning of patients (questionnaires and in-depth interview) - Identification of treatment aspects important for patient experience (in-depth interview) - Etiology of potential change in recovery effects (re-analysis of existing clinical brain scans that will be requested at CFX) The in-depth interview will cover the following apsects - Perceived importance of personal characteristics (e.g., motivation, willpower, hope) - Role of contextual characteristics (e.g., commitment of health professionals, being away from home, social contacts with peers during treatment) - Planned follow-up trajectory after treatment (e.g. interventions or guidance)	—

Measure

Time frame

Secundary parameters relate to: - Qualitative change in functioning of patients (questionnaires and in-depth interview) - Identification of treatment aspects important for patient experience (in-depth interview) - Etiology of potential change in recovery effects (re-analysis of existing clinical brain scans that will be requested at CFX) The in-depth interview will cover the following apsects - Perceived importance of personal characteristics (e.g., motivation, willpower, hope) - Role of contextual characteristics (e.g., commitment of health professionals, being away from home, social contacts with peers during treatment) - Planned follow-up trajectory after treatment (e.g. interventions or guidance)

—

Countries

Netherlands

Outcome results