Digital intervention for post-concussion symptoms

Get Going After concussIonN Lite (GAIN Lite): A Digital Intervention to Reduce Impairing Post-concussional Mild-to-moderate Symptoms in Adults

This study is testing a new digital program called GAIN Lite to see if it helps adults with ongoing concussion symptoms feel better compared to regular care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University of Aarhus (other)
• Locations: 1 site (Hammel, Deb´nmark)
• Trial ID: NCT05233475 on ClinicalTrials.gov

What this trial studies

This study aims to develop and test a digital intervention called 'Get Going After concussion Lite' (GAIN Lite) for adults experiencing persistent mild-to-moderate post-concussional symptoms. It will compare the efficacy of GAIN Lite against enhanced usual care in a randomized controlled trial involving 100 participants diagnosed with a concussion. The study also seeks to explore the relationship between physical activity, digital behavior, and symptom severity. Participants will be recruited from hospitals and general practitioners in the Central Denmark Region.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 who have experienced a concussion and are living in the Central Denmark Region.

Not a fit: Patients with objective neurological findings or those who have had a previous concussion within the last two years may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the severity of post-concussional symptoms and improve quality of life for affected individuals.

How similar studies have performed: Previous studies have shown promising results for similar interventions targeting post-concussion symptoms, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri (26). The criteria are based on recommendations by the WHO Task Force, 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;
2. Age 18 to 60 years at the time of the trauma;
3. A total score of 10-30 on RPQ within 1 week before enrolment in the study;
4. Able to understand, speak and read Danish;
5. Living in Central Denmark Region;
6. Identified from registers of the emergency departments or referred by GPs to GAIN Lite within 2-4 months after a concussion

Exclusion Criteria:

1. Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed;
2. Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion
3. Severe misuse of alcohol, prescription drugs and/or illegal drugs
4. Severe psychiatric co-morbidity (e.g. bipolar disorder, autism, psychotic disorder (life time)) or severe neurological disease (e.g. multiple sclerosis) that impedes participation in the programme.

Where this trial is running

Hammel, Deb´nmark

• Hammel Neurorehabilitation Centre and University Research Clinic — Hammel, Deb´nmark, Denmark (RECRUITING)

Study contacts

• Principal investigator: Sedsel Pedersen, PhD student — Hammel Neurorehabilitation Centre and University Research Clinic
• Study coordinator: Sedsel Pedersen, PhD student

Conditions: Brain Concussion, Mild Traumatic Brain Injury, Commotio Cerebri, Brain concussion, Behavior therapy, Early intervention, Mild traumatic brain injury, Post-concussion syndrome