Brain ConcussionNCT02337101
Early Intervention Programme for Young Patients (Aged 15 - 30 Years) With Symptoms Following Concussion.
A study testing EUC + Early intervention programme in people with Brain Concussion and Post-Concussion Syndrome, run by University of Aarhus at 1 site in Denmark.
Trial summary
Background: Five - 15 % of patients with concussion continue to experience impairing physical, cognitive and emotional symptoms longer than 3 months post-injury. Currently, no standardised treatment is available for patients with persistent post-concussional symptoms (PCS) and systematic treatment studies remain… Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Brain Concussion, Post-Concussion Syndrome
- What is being tested?
- EUC + Early intervention programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri 5 within the last 2 - 6 months. The criteria is based on the diagnostic criteria recommended by the WHO Task Force 1, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas.
- Age between 15 and 30 years at the time of the head trauma.
- Able to understand, speak and read Danish.
- A score of 20 or more on the Rivermead Post Concussion Symptoms Questionnaire (RPQ).
Who cannot join
- Objective neurological findings from neurological examination and / or acute trauma CT scan, indicating neurological disease or brain damage.
- Previous concussion leading to persistent post-concussional symptoms within the last two years.
- Severe misuse of alcohol, prescription drugs and / or illegal drugs.
- Multiorgan Bodily Distress Syndrome (multiple somatic symptoms from various body sites and organ systems not related to the accident).
- Psychiatric morbidity (Bipolar Disorder, severe Attention Deficit Hyperactivity Disorder, autism, psychotic disorder (life time)), or other psychiatric illness that impedes participation in the treatment.
- Severe neurological disease and / or other medical disease that impedes participation in the treatment programme.
- Significant learning and / or reading difficulties or mental retardation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Intervention Programme for Impairing Post-concussional Symptoms in Adolescents and Young Adults: Randomised Trial
Background:
Five - 15 % of patients with concussion continue to experience impairing physical, cognitive and emotional symptoms longer than 3 months post-injury. Currently, no standardised treatment is available for patients with persistent post-concussional symptoms (PCS) and systematic treatment studies remain limited.
Read more
Aim:
- to develop an early intervention programme based on principles from cognitive-behavioural therapy and graded exercise for young patients with PCS lasting more than 3 months, and
- to evaluate the efficacy of this intervention on PCS in a randomised, controlled trial.
Methods:
Patients aged 15 - 30 years diagnosed with concussion at hospitals in Central Denmark Region will be screened for persistent symptoms two months post-injury. Those with impairing symptoms will be invited to participate in a randomised controlled trial comparing the early intervention programme with enhanced usual care. We expect to include 120 patients from 2015-2016. Treatment will be interdisciplinary and will begin approximately 3 - 5 months after concussion. All patients will complete self-report measures at baseline and 3, 6 and 15 months after randomisation. The primary outcome is severity of PCS.
Read the detailed description
Background Concussion is an important public health concern. Debilitating and persistent post-concussional symptoms are associated with considerable long-term sickness and markedly reduced health-related quality of life in industrialized countries. In Denmark, approximately 25000 people are diagnosed with concussion each year. Although complete resolution of typical post-concussional symptoms such as headaches, dizziness and fatigue normally occur within the first days or weeks after a concussion, a significant proportion corresponding to five to15 % of patients continue to experience symptoms longer than 3 months post-injury. These patients are at risk of long-term sickness, reduced health-related quality of life as well as permanently reduced working ability, which is particularly disastrous for adolescents and young adults. Currently, no standardised treatment is available for patients with persistent post-concussional symptoms.
The aetiology of persistent post-concussional symptoms is only partly elicited, and no consensus exists whether post-concussional symptoms constitute a true syndrome linked to neurobiological disturbances caused by accident or head trauma. Nevertheless, the term post-concussional syndrome is widely used to describe a set of persistent somatic and emotional symptoms often observed in concussed individuals. We use the abbreviation 'PCS' as a purely descriptive term for post-concussional symptoms. The literature suggest, that PCS are best understood in a complex, multifactorial model, where both biological and psychological factors contribute to persistent symptoms and associated disability. Moreover, PCS overlap considerably with symptoms of other trauma-related conditions such as whiplash-associated disorders and post-traumatic stress disorder. On this background, a number of trials have tested the effect of various psychosocial interventions, including cognitive behavioural therapy (CBT), on persistent PCS. Although preliminary, there is some promising evidence that treatment based on the cognitive-behavioural model may be effective in treating PCS and prevent permanent suffering and disability.
Some of the cognitive - behavioural mechanisms that have been found to play an important role in the maintenance of PCS are unhelpful illness perceptions, maladaptive coping strategies and all-or-nothing behaviour. The all-or-nothing behaviour refers to a behavioural response, where patients overdo things when they believe symptoms are abating and then spend prolonged periods recovering when symptoms reappear. Other patients report a gradual restriction of activity over time, because they fear worsening of symptoms. A promising avenue for treatment seems to be focusing on making sustainable, gradual increases in levels of activity (in intensity and / or duration) over time, and to avoid extreme oscillations. This is often referred to as Graded Exercise Therapy (GET), a treatment that can effectively reduce impairment and suffering in chronic fatigue and persistent pain and that can be provided by physiotherapists and hence delivered in a primary care or municipality setting.
Currently, systematic studies of psychosocial interventions for patients with persistent PCS remain limited. A recent review concludes that more rigorous, large-scale randomised controlled trials (RCT) evaluating the effectiveness of CBT for persistent PCS are needed.
Aim:
- to develop an early intervention programme based on CBT and GET principles for young patients aged 15 - 30 years with PCS lasting more than three months, and
- to evaluate the efficacy of this intervention programme on PCS in a RCT.
Hypotheses Primary hypothesis Patients in the early intervention group will 6 months after randomisation report a statistically and clinically significantly greater reduction of post-concussional symptoms compared to patients who receive enhanced usual care.
Secondary hypotheses
- Patients in the early intervention group will 6 months after randomisation report a statistically and clinically significantly higher health related quality of life and overall daily functioning compared to patients who receive enhanced usual care.
- Patients in the early intervention group will during the 12 months after treatment have less consumption of health care (based on register-data) and less illness-related absence from school or work (based on self-reported data) compared to patients, who receive enhanced usual care.
- Conditions
- Brain Concussion, Post-Concussion Syndrome
- Being tested
- Enhanced Usual Care (EUC), EUC + Early intervention programme
- Keywords
- Brain concussion, Mild Traumatic Brain Injury, Post-concussion symptoms, Therapy, Randomised controlled trial, Cognitive assessment
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual Care (EUC)Other
All patients will have a brief clinical psychiatric and neurological assessment in order to determine eligibility, and will be provided with information and advice about typical post-concussional symptoms, the typical recovery process and the use of pain medication.
EUC + Early intervention programmeBehavioural
All patients will have a brief clinical psychiatric and neurological assessment in order to determine eligibility, and will be provided with information and advice about typical post-concussional symptoms, the typical recovery process and the use of pain medication.
The early intervention programme will be interdisciplinary and will mainly be provided by an occupational therapist and a physiotherapist under supervision of a neuropsychologist. It will be based on psychoeducation and principles from Cognitive Behavioral Therapy and Graded Exercise Therapy and targeted to patients' individual goals.
Patients will receive 8 weekly treatment sessions (3 group based and 5 individual sessions). Intervention will start approximately 4-5 months after the concussion.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care (EUC) | Active comparator | Clinical psychiatric and neurological assessment. Information and advice. Receives: Other: Enhanced Usual Care (EUC) |
| EUC + Early intervention programme | Experimental | Clinical psychiatric and neurological assessment. Information and advice. Individually targeted treatment programme. Receives: Behavioral: EUC + Early intervention programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of PCS measured by the Rivermead Post-concussion Symptoms Questionnaire (RPQ)
Self-rated post-concussion symptoms
Measured: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Secondary outcomes (10)
Quality of life and overall functioning measured by Quality of Life After Brain Injury - Overall Scale (QOLIBRI) and Short Form health status questionnaire from the medical outcome status (SF-36).
Measured: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Subjective improvement measured by Patient Global Impression of Change (PGIC)
Measured: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Somatisation measured by Bodily Distress Syndrome Checklist (BDS checklist)
Measured: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Anxiety and depression severity measured by a subscale (SCL-8) of Symptom Check List, 90 items (SCL-90).
Measured: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint)and 15 months after baseline.
Health Anxiety measured by Whitely-8 index
Measured: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Consumption of health care (extracted from Danish national registers) and degree of illness related absence from school or work (self-reported).
Measured: 15 months after baseline (i.e. after clinical assessment)
Self-reported cognitive functioning measured by Behavior Rating Inventory of Executive Function (BRIEF)
Measured: At baseline (i.e. at clinical assessment) and 6 months after baseline (primary endpoint).
Change in illness related cognitions measured by The Brief Illness Perception Questionnaire (B-IPQ)
Process measure
Measured: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Change in illness-related behaviours measured by the Behavioural Responses to Illness Questionnaire - short form (BRIQ - short form)
Process measure
Measured: At baseline (i.e. at clinical assessment) and 3,6 and 15 months after baseline.
Change in perceived stress measured by Perceived Stress Scale (PSS)
Process measure
Measured: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Central Denmark Region, Regionshospitalet Hammel Neurocenter
- Responsible party
- Sponsor
- Investigators
- Andreas Schröder, MD, PhD, Principal investigator, Aarhus University HospitalCharlotte U Rask, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337101
- Sponsor's protocol ID
- 18122014
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2015
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Thastum MM, Rask CU, Naess-Schmidt ET, Tuborgh A, Jensen JS, Svendsen SW, Nielsen JF, Schroder A. Novel interdisciplinary intervention, GAIN, vs. enhanced usual care to reduce high levels of post-concussion symptoms in adolescents and young adults 2-6 months post-injury: A randomised trial. EClinicalMedicine. 2019 Dec 16;17:100214. doi: 10.1016/j.eclinm.2019.11.007. eCollection 2019 Dec.
PubMed 31891145
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention Programme for Impairing Post-concussional Symptoms in Adolescents and Young Adults: Randomised Trial
- ClinicalTrials.gov ID
- NCT02337101
- Acronym / sponsor ID
- 18122014
- Conditions
- Brain Concussion, Post-Concussion Syndrome
- Keywords
- Brain concussion, Mild Traumatic Brain Injury, Post-concussion symptoms, Therapy, Randomised controlled trial, Cognitive assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Central Denmark Region, Regionshospitalet Hammel Neurocenter
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Five - 15 % of patients with concussion continue to experience impairing physical, cognitive and emotional symptoms longer than 3 months post-injury. Currently, no standardised treatment is available for patients with persistent post-concussional symptoms (PCS) and systematic treatment studies remain limited.
Aim:
- to develop an early intervention programme based on principles from cognitive-behavioural therapy and graded exercise for young patients with PCS lasting more than 3 months, and
- to evaluate the efficacy of this intervention on PCS in a randomised, controlled trial.
Methods:
Patients aged 15 - 30 years diagnosed with concussion at hospitals in Central Denmark Region will be screened for persistent symptoms two months post-injury. Those with impairing symptoms will be invited to participate in a randomised controlled trial comparing the early intervention programme with enhanced usual care. We expect to include 120 patients from 2015-2016. Treatment will be interdisciplinary and will begin approximately 3 - 5 months after concussion. All patients will complete self-report measures at baseline and 3, 6 and 15 months after randomisation. The primary outcome is severity of PCS.
Detailed description
Background Concussion is an important public health concern. Debilitating and persistent post-concussional symptoms are associated with considerable long-term sickness and markedly reduced health-related quality of life in industrialized countries. In Denmark, approximately 25000 people are diagnosed with concussion each year. Although complete resolution of typical post-concussional symptoms such as headaches, dizziness and fatigue normally occur within the first days or weeks after a concussion, a significant proportion corresponding to five to15 % of patients continue to experience symptoms longer than 3 months post-injury. These patients are at risk of long-term sickness, reduced health-related quality of life as well as permanently reduced working ability, which is particularly disastrous for adolescents and young adults. Currently, no standardised treatment is available for patients with persistent post-concussional symptoms.
The aetiology of persistent post-concussional symptoms is only partly elicited, and no consensus exists whether post-concussional symptoms constitute a true syndrome linked to neurobiological disturbances caused by accident or head trauma. Nevertheless, the term post-concussional syndrome is widely used to describe a set of persistent somatic and emotional symptoms often observed in concussed individuals. We use the abbreviation 'PCS' as a purely descriptive term for post-concussional symptoms. The literature suggest, that PCS are best understood in a complex, multifactorial model, where both biological and psychological factors contribute to persistent symptoms and associated disability. Moreover, PCS overlap considerably with symptoms of other trauma-related conditions such as whiplash-associated disorders and post-traumatic stress disorder. On this background, a number of trials have tested the effect of various psychosocial interventions, including cognitive behavioural therapy (CBT), on persistent PCS. Although preliminary, there is some promising evidence that treatment based on the cognitive-behavioural model may be effective in treating PCS and prevent permanent suffering and disability.
Some of the cognitive - behavioural mechanisms that have been found to play an important role in the maintenance of PCS are unhelpful illness perceptions, maladaptive coping strategies and all-or-nothing behaviour. The all-or-nothing behaviour refers to a behavioural response, where patients overdo things when they believe symptoms are abating and then spend prolonged periods recovering when symptoms reappear. Other patients report a gradual restriction of activity over time, because they fear worsening of symptoms. A promising avenue for treatment seems to be focusing on making sustainable, gradual increases in levels of activity (in intensity and / or duration) over time, and to avoid extreme oscillations. This is often referred to as Graded Exercise Therapy (GET), a treatment that can effectively reduce impairment and suffering in chronic fatigue and persistent pain and that can be provided by physiotherapists and hence delivered in a primary care or municipality setting.
Currently, systematic studies of psychosocial interventions for patients with persistent PCS remain limited. A recent review concludes that more rigorous, large-scale randomised controlled trials (RCT) evaluating the effectiveness of CBT for persistent PCS are needed.
Aim:
- to develop an early intervention programme based on CBT and GET principles for young patients aged 15 - 30 years with PCS lasting more than three months, and
- to evaluate the efficacy of this intervention programme on PCS in a RCT.
Hypotheses Primary hypothesis Patients in the early intervention group will 6 months after randomisation report a statistically and clinically significantly greater reduction of post-concussional symptoms compared to patients who receive enhanced usual care.
Secondary hypotheses
- Patients in the early intervention group will 6 months after randomisation report a statistically and clinically significantly higher health related quality of life and overall daily functioning compared to patients who receive enhanced usual care.
- Patients in the early intervention group will during the 12 months after treatment have less consumption of health care (based on register-data) and less illness-related absence from school or work (based on self-reported data) compared to patients, who receive enhanced usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care (EUC) | Active comparator | Other: Enhanced Usual Care (EUC)Clinical psychiatric and neurological assessment. Information and advice. |
| EUC + Early intervention programme | Experimental | Behavioral: EUC + Early intervention programmeClinical psychiatric and neurological assessment. Information and advice. Individually targeted treatment programme. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri 5 within the last 2 - 6 months. The criteria is based on the diagnostic criteria recommended by the WHO Task Force 1, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas.
- Age between 15 and 30 years at the time of the head trauma.
- Able to understand, speak and read Danish.
- A score of 20 or more on the Rivermead Post Concussion Symptoms Questionnaire (RPQ).
Key exclusion criteria (7 listed)
- Objective neurological findings from neurological examination and / or acute trauma CT scan, indicating neurological disease or brain damage.
- Previous concussion leading to persistent post-concussional symptoms within the last two years.
- Severe misuse of alcohol, prescription drugs and / or illegal drugs.
- Multiorgan Bodily Distress Syndrome (multiple somatic symptoms from various body sites and organ systems not related to the accident).
- Psychiatric morbidity (Bipolar Disorder, severe Attention Deficit Hyperactivity Disorder, autism, psychotic disorder (life time)), or other psychiatric illness that impedes participation in the treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Usual Care (EUC)All patients will have a brief clinical psychiatric and neurological assessment in order to determine eligibility, and will be provided with information and advice about typical post-concussional symptoms, the typical recovery process and the use of pain medication. | Other | Enhanced Usual Care (EUC) |
| EUC + Early intervention programmeAll patients will have a brief clinical psychiatric and neurological assessment in order to determine eligibility, and will be provided with information and advice about typical post-concussional symptoms, the typical recovery process and the use of pain medication. The early intervention programme will be interdisciplinary and will mainly be provided by an occupational therapist and a physiotherapist under supervision of a neuropsychologist. It will be based on psychoeducation and principles from Cognitive Behavioral Therapy and Graded Exercise Therapy and targeted to patients' individual goals. Patients will receive 8 weekly treatment sessions (3 group based and 5 individual sessions). Intervention will start approximately 4-5 months after the concussion. | Behavioural | EUC + Early intervention programme |
Primary outcome
Severity of PCS measured by the Rivermead Post-concussion Symptoms Questionnaire (RPQ)
Time frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Self-rated post-concussion symptoms
10 secondary outcomes
Quality of life and overall functioning measured by Quality of Life After Brain Injury - Overall Scale (QOLIBRI) and Short Form health status questionnaire from the medical outcome status (SF-36).
Time frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Subjective improvement measured by Patient Global Impression of Change (PGIC)
Time frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Somatisation measured by Bodily Distress Syndrome Checklist (BDS checklist)
Time frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Anxiety and depression severity measured by a subscale (SCL-8) of Symptom Check List, 90 items (SCL-90).
Time frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint)and 15 months after baseline.
Health Anxiety measured by Whitely-8 index
Time frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Consumption of health care (extracted from Danish national registers) and degree of illness related absence from school or work (self-reported).
Time frame: 15 months after baseline (i.e. after clinical assessment)
Self-reported cognitive functioning measured by Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: At baseline (i.e. at clinical assessment) and 6 months after baseline (primary endpoint).
Change in illness related cognitions measured by The Brief Illness Perception Questionnaire (B-IPQ)
Time frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Change in illness-related behaviours measured by the Behavioural Responses to Illness Questionnaire - short form (BRIQ - short form)
Time frame: At baseline (i.e. at clinical assessment) and 3,6 and 15 months after baseline.
Change in perceived stress measured by Perceived Stress Scale (PSS)
Time frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Derived from this study: PubMed 31891145Thastum MM, Rask CU, Naess-Schmidt ET, Tuborgh A, Jensen JS, Svendsen SW, Nielsen JF, Schroder A. Novel interdisciplinary intervention, GAIN, vs. enhanced usual care to reduce high levels of post-concussion symptoms in adolescents and young adults 2-6 months post-injury: A randomised trial. EClinicalMedicine. 2019 Dec 16;17:100214. doi: 10.1016/j.eclinm.2019.11.007. eCollection 2019 Dec.
- Homepage for the Research Clinic for Functional Disorders, Aarhus University HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Schröder, MD, PhD principal investigator
Aarhus University Hospital
Charlotte U Rask, MD, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUC + Early intervention programme in people with Brain Concussion and Post-Concussion Syndrome, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of PCS measured by the Rivermead Post-concussion Symptoms Questionnaire (RPQ) (time frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02337101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.