<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03237676</url>
  </required_header>
  <id_info>
    <org_study_id>PO037-2015A</org_study_id>
    <nct_id>NCT03237676</nct_id>
  </id_info>
  <brief_title>The Effect of Cognitive Rehabilitation Therapy in Improving Cognitive Function of Attention Following Mild Traumatic Brain Injury</brief_title>
  <official_title>The Effect of Cognitive Rehabilitation Therapy in Improving Cognitive Function of Attention Following Mild Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is a randomised controlled study. The study hypothesis is cognitive&#xD;
      rehabilitation for attention deficits following mild traumatic brain injury will improve&#xD;
      patient's cognitive outcome, measured by neuropsychological and neuroimaging parameters.&#xD;
      Participant recruitment is from University Malaya Medical Centre, Malaysia. All mild&#xD;
      traumatic brain injury participants have to fulfil the study inclusion criteria and written&#xD;
      consented for therapy. Control group receives existing patient-centred cognitive treatment&#xD;
      whereas intervention group receives individualised structured cognitive rehabilitation&#xD;
      therapy. The intervention begins at three months post injury and ends at six months post&#xD;
      injury. Study outcome measurements are applied at pre and post treatment. This study was&#xD;
      ethically approved by Medical Research Ethics Committee University Malaya Medical Centre&#xD;
      (MREC ID NO: 2016928-4293).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      General study objective: to measure the effect of cognitive rehabilitation program for&#xD;
      attention deficit applied in mild traumatic brain injury patients.&#xD;
&#xD;
      Specific objectives:&#xD;
&#xD;
        1. To measure the effect of a 12-week cognitive rehabilitation therapy for attention&#xD;
           deficits in mild traumatic brain injury patients using neuropsychological and functional&#xD;
           assessments.&#xD;
&#xD;
        2. To examine the correlation between neurocognitive deficits and structural brain changes&#xD;
           at baseline and at six months post injury.&#xD;
&#xD;
      Study type and location: An interventional study conducted in University Malaya Medical&#xD;
      Centre (UMMC), Malaysia.&#xD;
&#xD;
      Participants: Patients diagnosed with mild traumatic brain injury at Accident &amp; Emergency&#xD;
      Department in UMMC.&#xD;
&#xD;
      Outcome measures:&#xD;
&#xD;
        1. Neuropsychological Assessment Battery-Screening test&#xD;
&#xD;
        2. Diffusion Tensor Imaging parameters&#xD;
&#xD;
        3. Goal Attainment Scaling&#xD;
&#xD;
      Ethics approval: approved MREC ID NO: 2016928-4293&#xD;
&#xD;
      Consent: informed written consent will be obtained from all participants of research.&#xD;
&#xD;
      Estimated sample size:&#xD;
&#xD;
      Based on medium effect size Cohen's d = 0.35 Investigators used G*Power Version 3.1.9.2 for&#xD;
      sample size calculation. Sample size calculated: 60 Estimating drop out rate of 40%=24.&#xD;
      Therefore sample size target n= 84 mTBI patients.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      A two arm randomised controlled trial:&#xD;
&#xD;
        1. Mild traumatic brain injury control group, and&#xD;
&#xD;
        2. Mild traumatic brain injury intervention group.&#xD;
&#xD;
      The study protocol is divided into 3 segments:&#xD;
&#xD;
        1. Neurocognitive evaluation protocol:&#xD;
&#xD;
           Investigators will perform Neuropsychological Assessment Battery-Screening test on both&#xD;
           groups at three months and at six months following brain injury.&#xD;
&#xD;
        2. Imaging protocol:&#xD;
&#xD;
           Investigators perform Diffusion Tensor Imaging for both groups at three months and at&#xD;
           six months following brain injury.&#xD;
&#xD;
        3. Cognitive rehabilitation therapy protocol:&#xD;
&#xD;
      The focus is on attention deficits. Each study arm will receive different treatment&#xD;
      approaches.&#xD;
&#xD;
      Mild traumatic brain injury control group will receive a patient-centred cognitive therapy.&#xD;
      This is an application of existing cognitive rehabilitation treatment available at UMMC,&#xD;
      which include therapy session on symptoms management and coping strategies. This is performed&#xD;
      and monitored by a cognitive therapy trained Occupational Therapist. Clinical and treatment&#xD;
      review are provided as part of routine outpatient rehabilitation clinic review.&#xD;
&#xD;
      Mild traumatic brain injury intervention group will receive individualised structured&#xD;
      cognitive rehabilitation therapy that consist of:&#xD;
&#xD;
        1. Direct attention training:&#xD;
&#xD;
           A deficit-oriented evidence-based treatment approach. The therapy for attention is&#xD;
           computer-based and is divided into focused attention, selective attention, divided&#xD;
           attention and sustained attention. Each treatment session is conducted by a trained&#xD;
           Occupational Therapist in cognitive therapy and a rehabilitation medicine physician.&#xD;
&#xD;
        2. Strategic approach (metacognitive):&#xD;
&#xD;
      This involves generalisation of tasks to everyday functional skills. This approach is applied&#xD;
      after each direct attention training session. This approach include review of individualised&#xD;
      goals, review of cognitive related problem(s) encountered in participants daily activities&#xD;
      since injury and problem-solving training. This is also performed by similar trained&#xD;
      Occupational Therapist and reviewed by a rehabilitation medicine physician.&#xD;
&#xD;
      Randomisation sampling: Investigators apply simple randomisation in selection of mild&#xD;
      traumatic brain injury control and intervention group participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>intervention group receives structured cognitive rehabilitation therapy, control group receives conventional/pre-existing cognitive rehabilitation therapy.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants are randomised on treatment arm. Co-investigators are blinded from knowing which participant receives which treatment arm.&#xD;
Cognitive outcome assessor is blinded from knowing which participant receives which treatment arm.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Neuropsychological Assessment Battery- Screening score</measure>
    <time_frame>Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury</time_frame>
    <description>Measure the change in score of Attention domain screening score and Total Screening Index Score at two different time points - 3 months and 6 months post brain injury.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Diffusion Tensor Imaging parameters</measure>
    <time_frame>Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury</time_frame>
    <description>Measure the change in mean values of white matter tract parameters at two different time points - 3 months and 6 months post brain injury.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Goal Attainment Scaling score</measure>
    <time_frame>Perform at 3 months (baseline) and 6 months (complete intervention) following mild traumatic brain injury</time_frame>
    <description>Measure the change in Goal Attainment Scaling calculation score at two different time points - 3 months and 6 months post brain injury.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Mild Traumatic Brain Injury</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Individualised structured cognitive rehabilitation therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants of interventional arm will receive individualised structured cognitive rehabilitation therapy at the proposed health centre (University Malaya Medical Centre, Malaysia).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient-centred cognitive therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants of conventional arm will receive an existing cognitive rehabilitation treatment available at the proposed health centre (University Malaya Medical Centre, Malaysia).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Structured cognitive rehabilitation therapy</intervention_name>
    <description>A computer-based cognitive rehabilitation therapy Therapy frequency is one hour session per week for three months.</description>
    <arm_group_label>Individualised structured cognitive rehabilitation therapy</arm_group_label>
    <other_name>cognitive therapy</other_name>
    <other_name>CogniPlus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient-centred cognitive therapy</intervention_name>
    <description>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.&#xD;
Clinical and treatment review are provided as part of routine outpatient rehabilitation clinic review.</description>
    <arm_group_label>Patient-centred cognitive therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild traumatic brain injury as a result of motor vehicle accidents only.&#xD;
&#xD;
          -  No previous history of head trauma.&#xD;
&#xD;
          -  Education level of a minimum of 9 years (required for neuropsychological test).&#xD;
&#xD;
          -  Normal Computed Tomography (CT) brain scan finding.&#xD;
&#xD;
          -  Able to comply with cognitive rehabilitation therapy.&#xD;
&#xD;
          -  No pre-existing chronic illness that can cause neurological complications,&#xD;
             neurological diseases or psychiatric condition.&#xD;
&#xD;
          -  Not on any regular medication that may alter or effect cognitive and psychological&#xD;
             status.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Normal neuropsychological assessment test result at 3 months post injury (planned test&#xD;
             time) for both study groups.&#xD;
&#xD;
          -  Clinical evidence of alcohol influence at time of injury.&#xD;
&#xD;
          -  Non Malaysian citizens&#xD;
&#xD;
          -  Major polytrauma including long bone fractures, intra-abdominal injuries and chest&#xD;
             injuries that require surgical and/or metal insertion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Norhamizan Hamzah, MBChB,MRehabMed</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rehabilitation Medicine Specialist, University of Malaya</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mazlina Mazlan, MBBS,MRehabMed</last_name>
    <role>Study Chair</role>
    <affiliation>Consultant Rehabilitation Medicine &amp; Associate Professor, University of Malaya</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vairavan Narayanan, MBBS,MSURG,FRCS</last_name>
    <role>Study Chair</role>
    <affiliation>Consultant Neurosurgeon &amp; Associate Professor, University of Malaya</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Norlisah Ramli, MBBS,FRCR</last_name>
    <role>Study Chair</role>
    <affiliation>Consultant Neuroradiologist &amp; Professor, University of Malaya</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Malaya Medical Centre</name>
      <address>
        <city>Kuala Lumpur</city>
        <state>Wilayah Persekutuan</state>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <reference>
    <citation>Veeramuthu V, Narayanan V, Kuo TL, Delano-Wood L, Chinna K, Bondi MW, Waran V, Ganesan D, Ramli N. Diffusion Tensor Imaging Parameters in Mild Traumatic Brain Injury and Its Correlation with Early Neuropsychological Impairment: A Longitudinal Study. J Neurotrauma. 2015 Oct 1;32(19):1497-509. doi: 10.1089/neu.2014.3750. Epub 2015 Jun 11.</citation>
    <PMID>25952562</PMID>
  </reference>
  <reference>
    <citation>Veeramuthu V, Narayanan V, Ramli N, Hernowo A, Waran V, Bondi MW, Delano-Wood L, Ganesan D. Neuropsychological Outcomes in Patients with Complicated Versus Uncomplicated Mild Traumatic Brain Injury: 6-Month Follow-Up. World Neurosurg. 2017 Jan;97:416-423. doi: 10.1016/j.wneu.2016.10.041. Epub 2016 Oct 15.</citation>
    <PMID>27751922</PMID>
  </reference>
  <reference>
    <citation>Veeramuthu V, Hariri F, Narayanan V, Tan LK, Ramli N, Ganesan D. Microstructural Change and Cognitive Alteration in Maxillofacial Trauma and Mild Traumatic Brain Injury: A Diffusion Tensor Imaging Study. J Oral Maxillofac Surg. 2016 Jun;74(6):1197.e1-1197.e10. doi: 10.1016/j.joms.2016.01.042. Epub 2016 Jan 30.</citation>
    <PMID>26917201</PMID>
  </reference>
  <reference>
    <citation>Marshall S, Bayley M, McCullagh S, Velikonja D, Berrigan L, Ouchterlony D, Weegar K; mTBI Expert Consensus Group. Updated clinical practice guidelines for concussion/mild traumatic brain injury and persistent symptoms. Brain Inj. 2015;29(6):688-700. doi: 10.3109/02699052.2015.1004755. Epub 2015 Apr 14.</citation>
    <PMID>25871303</PMID>
  </reference>
  <reference>
    <citation>Carroll LJ, Cassidy JD, Cancelliere C, Cote P, Hincapie CA, Kristman VL, Holm LW, Borg J, Nygren-de Boussard C, Hartvigsen J. Systematic review of the prognosis after mild traumatic brain injury in adults: cognitive, psychiatric, and mortality outcomes: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis. Arch Phys Med Rehabil. 2014 Mar;95(3 Suppl):S152-73. doi: 10.1016/j.apmr.2013.08.300.</citation>
    <PMID>24581903</PMID>
  </reference>
  <reference>
    <citation>Cassidy JD, Cancelliere C, Carroll LJ, Cote P, Hincapie CA, Holm LW, Hartvigsen J, Donovan J, Nygren-de Boussard C, Kristman VL, Borg J. Systematic review of self-reported prognosis in adults after mild traumatic brain injury: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis. Arch Phys Med Rehabil. 2014 Mar;95(3 Suppl):S132-51. doi: 10.1016/j.apmr.2013.08.299.</citation>
    <PMID>24581902</PMID>
  </reference>
  <reference>
    <citation>Hulkower MB, Poliak DB, Rosenbaum SB, Zimmerman ME, Lipton ML. A decade of DTI in traumatic brain injury: 10 years and 100 articles later. AJNR Am J Neuroradiol. 2013 Nov-Dec;34(11):2064-74. doi: 10.3174/ajnr.A3395. Epub 2013 Jan 10.</citation>
    <PMID>23306011</PMID>
  </reference>
  <reference>
    <citation>das Nair R, Lincoln NB, Ftizsimmons D, Brain N, Montgomery A, Bradshaw L, Drummond A, Sackley C, Newby G, Thornton J, Stapleton S, Pink A. Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial. Trials. 2015 Jan 6;16:6. doi: 10.1186/1745-6215-16-6.</citation>
    <PMID>25559090</PMID>
  </reference>
  <reference>
    <citation>Temple RO, Zgaljardic DJ, Abreu BC, Seale GS, Ostir GV, Ottenbacher KJ. Ecological validity of the neuropsychological assessment battery screening module in post-acute brain injury rehabilitation. Brain Inj. 2009 Jan;23(1):45-50. doi: 10.1080/02699050802590361.</citation>
    <PMID>19096970</PMID>
  </reference>
  <reference>
    <citation>Zgaljardic DJ, Temple RO. Reliability and validity of the Neuropsychological Assessment Battery-Screening Module (NAB-SM) in a sample of patients with moderate-to-severe acquired brain injury. Appl Neuropsychol. 2010 Jan;17(1):27-36. doi: 10.1080/09084280903297909.</citation>
    <PMID>20146119</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>November 5, 2020</last_update_submitted>
  <last_update_submitted_qc>November 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cognitive rehabilitation</keyword>
  <keyword>diffusion tensor imaging</keyword>
  <keyword>neuropsychology</keyword>
  <keyword>functional outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Brain Concussion</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03237676
org study id: PO037-2015A
nct id: NCT03237676
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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).
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.
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.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Participants are randomised on treatment arm. Co-investigators are blinded from knowing which participant receives which treatment arm.
Cognitive outcome assessor is blinded from knowing which participant receives which treatment arm.
measure: Change in Neuropsychological Assessment Battery- Screening score
time frame: Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury
description: Measure the change in score of Attention domain screening score and Total Screening Index Score at two different time points - 3 months and 6 months post brain injury.
measure: Change in Diffusion Tensor Imaging parameters
time frame: Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury
description: Measure the change in mean values of white matter tract parameters at two different time points - 3 months and 6 months post brain injury.
measure: Change in Goal Attainment Scaling score
time frame: Perform at 3 months (baseline) and 6 months (complete intervention) following mild traumatic brain injury
description: Measure the change in Goal Attainment Scaling calculation score at two different time points - 3 months and 6 months post brain injury.
arm group label: Individualised structured cognitive rehabilitation therapy
arm group type: Experimental
description: Participants of interventional arm will receive individualised structured cognitive rehabilitation therapy at the proposed health centre (University Malaya Medical Centre, Malaysia).
arm group label: Patient-centred cognitive therapy
arm group type: Active Comparator
description: Participants of conventional arm will receive an existing cognitive rehabilitation treatment available at the proposed health centre (University Malaya Medical Centre, Malaysia).
intervention type: Other
intervention name: Structured cognitive rehabilitation therapy
description: A computer-based cognitive rehabilitation therapy Therapy frequency is one hour session per week for three months.
arm group label: Individualised structured cognitive rehabilitation therapy
other name: cognitive therapy
other name: CogniPlus
intervention type: Other
intervention name: Patient-centred cognitive therapy
description: 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.
arm group label: Patient-centred cognitive therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Norhamizan Hamzah, MBChB,MRehabMed
role: Principal Investigator
affiliation: Rehabilitation Medicine Specialist, University of Malaya
last name: Mazlina Mazlan, MBBS,MRehabMed
role: Study Chair
affiliation: Consultant Rehabilitation Medicine & Associate Professor, University of Malaya
last name: Vairavan Narayanan, MBBS,MSURG,FRCS
role: Study Chair
affiliation: Consultant Neurosurgeon & Associate Professor, University of Malaya
last name: Norlisah Ramli, MBBS,FRCR
role: Study Chair
affiliation: Consultant Neuroradiologist & Professor, University of Malaya
facility: 
country: Malaysia
citation: Veeramuthu V, Narayanan V, Kuo TL, Delano-Wood L, Chinna K, Bondi MW, Waran V, Ganesan D, Ramli N. Diffusion Tensor Imaging Parameters in Mild Traumatic Brain Injury and Its Correlation with Early Neuropsychological Impairment: A Longitudinal Study. J Neurotrauma. 2015 Oct 1;32(19):1497-509. doi: 10.1089/neu.2014.3750. Epub 2015 Jun 11.
PMID: 25952562
citation: Veeramuthu V, Narayanan V, Ramli N, Hernowo A, Waran V, Bondi MW, Delano-Wood L, Ganesan D. Neuropsychological Outcomes in Patients with Complicated Versus Uncomplicated Mild Traumatic Brain Injury: 6-Month Follow-Up. World Neurosurg. 2017 Jan;97:416-423. doi: 10.1016/j.wneu.2016.10.041. Epub 2016 Oct 15.
PMID: 27751922
citation: Veeramuthu V, Hariri F, Narayanan V, Tan LK, Ramli N, Ganesan D. Microstructural Change and Cognitive Alteration in Maxillofacial Trauma and Mild Traumatic Brain Injury: A Diffusion Tensor Imaging Study. J Oral Maxillofac Surg. 2016 Jun;74(6):1197.e1-1197.e10. doi: 10.1016/j.joms.2016.01.042. Epub 2016 Jan 30.
PMID: 26917201
citation: Marshall S, Bayley M, McCullagh S, Velikonja D, Berrigan L, Ouchterlony D, Weegar K; mTBI Expert Consensus Group. Updated clinical practice guidelines for concussion/mild traumatic brain injury and persistent symptoms. Brain Inj. 2015;29(6):688-700. doi: 10.3109/02699052.2015.1004755. Epub 2015 Apr 14.
PMID: 25871303
citation: Carroll LJ, Cassidy JD, Cancelliere C, Cote P, Hincapie CA, Kristman VL, Holm LW, Borg J, Nygren-de Boussard C, Hartvigsen J. Systematic review of the prognosis after mild traumatic brain injury in adults: cognitive, psychiatric, and mortality outcomes: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis. Arch Phys Med Rehabil. 2014 Mar;95(3 Suppl):S152-73. doi: 10.1016/j.apmr.2013.08.300.
PMID: 24581903
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responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion
mesh term: Wounds and Injuries