The Effect of Cognitive Rehabilitation Therapy in Improving Cognitive Function of Attention Following Mild Traumatic Brain Injury
Condition: Mild Traumatic Brain Injury; Cognitive Impairment
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Interventional

Summary: 
      This research is a randomised controlled study. The study hypothesis is cognitive
      rehabilitation for attention deficits following mild traumatic brain injury will improve
      patient's cognitive outcome, measured by neuropsychological and neuroimaging parameters.
      Participant recruitment is from University Malaya Medical Centre, Malaysia. All mild
      traumatic brain injury participants have to fulfil the study inclusion criteria and written
      consented for therapy. Control group receives existing patient-centred cognitive treatment
      whereas intervention group receives individualised structured cognitive rehabilitation
      therapy. The intervention begins at three months post injury and ends at six months post
      injury. Study outcome measurements are applied at pre and post treatment. This study was
      ethically approved by Medical Research Ethics Committee University Malaya Medical Centre
      (MREC ID NO: 2016928-4293).
    

Detailed description: 
      General study objective: to measure the effect of cognitive rehabilitation program for
      attention deficit applied in mild traumatic brain injury patients.

      Specific objectives:

        1. To measure the effect of a 12-week cognitive rehabilitation therapy for attention
           deficits in mild traumatic brain injury patients using neuropsychological and functional
           assessments.

        2. To examine the correlation between neurocognitive deficits and structural brain changes
           at baseline and at six months post injury.

      Study type and location: An interventional study conducted in University Malaya Medical
      Centre (UMMC), Malaysia.

      Participants: Patients diagnosed with mild traumatic brain injury at Accident & Emergency
      Department in UMMC.

      Outcome measures:

        1. Neuropsychological Assessment Battery-Screening test

        2. Diffusion Tensor Imaging parameters

        3. Goal Attainment Scaling

      Ethics approval: approved MREC ID NO: 2016928-4293

      Consent: informed written consent will be obtained from all participants of research.

      Estimated sample size:

      Based on medium effect size Cohen's d = 0.35 Investigators used G*Power Version 3.1.9.2 for
      sample size calculation. Sample size calculated: 60 Estimating drop out rate of 40%=24.
      Therefore sample size target n= 84 mTBI patients.

      Study design:

      A two arm randomised controlled trial:

        1. Mild traumatic brain injury control group, and

        2. Mild traumatic brain injury intervention group.

      The study protocol is divided into 3 segments:

        1. Neurocognitive evaluation protocol:

           Investigators will perform Neuropsychological Assessment Battery-Screening test on both
           groups at three months and at six months following brain injury.

        2. Imaging protocol:

           Investigators perform Diffusion Tensor Imaging for both groups at three months and at
           six months following brain injury.

        3. Cognitive rehabilitation therapy protocol:

      The focus is on attention deficits. Each study arm will receive different treatment
      approaches.

      Mild traumatic brain injury control group will receive a patient-centred cognitive therapy.
      This is an application of existing cognitive rehabilitation treatment available at UMMC,
      which include therapy session on symptoms management and coping strategies. This is performed
      and monitored by a cognitive therapy trained Occupational Therapist. Clinical and treatment
      review are provided as part of routine outpatient rehabilitation clinic review.

      Mild traumatic brain injury intervention group will receive individualised structured
      cognitive rehabilitation therapy that consist of:

        1. Direct attention training:

           A deficit-oriented evidence-based treatment approach. The therapy for attention is
           computer-based and is divided into focused attention, selective attention, divided
           attention and sustained attention. Each treatment session is conducted by a trained
           Occupational Therapist in cognitive therapy and a rehabilitation medicine physician.

        2. Strategic approach (metacognitive):

      This involves generalisation of tasks to everyday functional skills. This approach is applied
      after each direct attention training session. This approach include review of individualised
      goals, review of cognitive related problem(s) encountered in participants daily activities
      since injury and problem-solving training. This is also performed by similar trained
      Occupational Therapist and reviewed by a rehabilitation medicine physician.

      Randomisation sampling: Investigators apply simple randomisation in selection of mild
      traumatic brain injury control and intervention group participants.
    

Intervention name(s): Structured cognitive rehabilitation therapy; Patient-centred cognitive therapy
Intervention type(s): Other; Other
Intervention description(s): A computer-based cognitive rehabilitation therapy Therapy frequency is one hour session per week for three months.; Application of existing cognitive therapy at University Malaya Medical Centre, Malaysia. It is a patient-centred therapy approach over a period of three months, which include therapy session on symptoms management and coping strategies.
Clinical and treatment review are provided as part of routine outpatient rehabilitation clinic review.
Other intervention name(s): cognitive therapy; CogniPlus
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intervention group receives structured cognitive rehabilitation therapy, control group receives conventional/pre-existing cognitive rehabilitation therapy.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive rehabilitation; diffusion tensor imaging; neuropsychology; functional outcome