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The Effect of Cognitive Rehabilitation Therapy in Improving Cognitive Function of Attention Following Mild Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03237676
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of Malaya

Brief 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).

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Cognitive Impairment Other: Structured cognitive rehabilitation therapy Other: Patient-centred cognitive therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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.
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.

Primary Purpose: Treatment
Official Title: The Effect of Cognitive Rehabilitation Therapy in Improving Cognitive Function of Attention Following Mild Traumatic Brain Injury
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Individualised structured cognitive rehabilitation therapy
Participants of interventional arm will receive individualised structured cognitive rehabilitation therapy at the proposed health centre (University Malaya Medical Centre, Malaysia).
Other: Structured cognitive rehabilitation therapy
A computer-based cognitive rehabilitation therapy Therapy frequency is one hour session per week for three months.
Other Names:
  • cognitive therapy
  • CogniPlus

Active Comparator: Patient-centred cognitive therapy
Participants of conventional arm will receive an existing cognitive rehabilitation treatment available at the proposed health centre (University Malaya Medical Centre, Malaysia).
Other: Patient-centred cognitive therapy

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.





Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Change in Diffusion Tensor Imaging parameters [ Time Frame: Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury ]
    Measure the change in mean values of white matter tract parameters at two different time points - 3 months and 6 months post brain injury.

  2. Change in Goal Attainment Scaling score [ Time Frame: Perform at 3 months (baseline) and 6 months (complete intervention) following mild traumatic brain injury ]
    Measure the change in Goal Attainment Scaling calculation score at two different time points - 3 months and 6 months post brain injury.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild traumatic brain injury as a result of motor vehicle accidents only.
  • No previous history of head trauma.
  • Education level of a minimum of 9 years (required for neuropsychological test).
  • Normal Computed Tomography (CT) brain scan finding.
  • Able to comply with cognitive rehabilitation therapy.
  • No pre-existing chronic illness that can cause neurological complications, neurological diseases or psychiatric condition.
  • Not on any regular medication that may alter or effect cognitive and psychological status.

Exclusion Criteria:

  • Normal neuropsychological assessment test result at 3 months post injury (planned test time) for both study groups.
  • Clinical evidence of alcohol influence at time of injury.
  • Non Malaysian citizens
  • Major polytrauma including long bone fractures, intra-abdominal injuries and chest injuries that require surgical and/or metal insertion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237676


Contacts
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Contact: Norhamizan Hamzah, MBChB,MRehabMed +60379496677 norhamizan@ummc.edu.my
Contact: Mazlina Mazlan, MBBS, MRehabMed +60379496685 mazlinamazlan@ummc.edu.my

Locations
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Malaysia
University Malaya Medical Centre Recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Contact: Norhamizan Hamzah, MBChB, MRehabMed    +60379496677    norhamizan@ummc.edu.my   
Contact: Mazlina Mazlan, MBBS, MRehabMed    +6079496685    mazlinamazlan@ummc.edu.my   
Principal Investigator: Norhamizan Hamzah, MBChB, MRehabMed         
Sub-Investigator: Mazlina Mazlan, MBBS, MRehabMed         
Sub-Investigator: Vairavan Narayanan, MBBS,MSURG,FRCS         
Sub-Investigator: Norlisah Ramli, MBBS, FRCR         
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: Norhamizan Hamzah, MBChB,MRehabMed Rehabilitation Medicine Specialist, University of Malaya
Study Chair: Mazlina Mazlan, MBBS,MRehabMed Consultant Rehabilitation Medicine & Associate Professor, University of Malaya
Study Chair: Vairavan Narayanan, MBBS,MSURG,FRCS Consultant Neurosurgeon & Associate Professor, University of Malaya
Study Chair: Norlisah Ramli, MBBS,FRCR Consultant Neuroradiologist & Professor, University of Malaya

Additional Information:
Publications:

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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT03237676     History of Changes
Other Study ID Numbers: PO037-2015A
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Malaya:
cognitive rehabilitation
diffusion tensor imaging
neuropsychology
functional outcome

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Cognitive Dysfunction
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders