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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:
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:
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:
The study protocol is divided into 3 segments:
Neurocognitive evaluation protocol:
Investigators will perform Neuropsychological Assessment Battery-Screening test on both groups at three months and at six months following brain injury.
Imaging protocol:
Investigators perform Diffusion Tensor Imaging for both groups at three months and at six months following brain injury.
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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualised structured cognitive rehabilitation therapy | Experimental | Participants of interventional arm will receive individualised structured cognitive rehabilitation therapy at the proposed health centre (University Malaya Medical Centre, Malaysia). |
|
| Patient-centred cognitive therapy | Active Comparator | Participants of conventional arm will receive an existing cognitive rehabilitation treatment available at the proposed health centre (University Malaya Medical Centre, Malaysia). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured cognitive rehabilitation therapy | Other | A computer-based cognitive rehabilitation therapy Therapy frequency is one hour session per week for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neuropsychological Assessment Battery- Screening score | 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. | Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diffusion Tensor Imaging parameters | Measure the change in mean values of white matter tract parameters at two different time points - 3 months and 6 months post brain injury. | Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury |
| Change in Goal Attainment Scaling score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norhamizan Hamzah, MBChB,MRehabMed | Rehabilitation Medicine Specialist, University of Malaya | Principal Investigator |
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Malaya Medical Centre | Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25952562 | Background | 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. | |
| 27751922 |
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intervention group receives structured cognitive rehabilitation therapy, control group receives conventional/pre-existing cognitive rehabilitation therapy.
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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.
|
| Patient-centred cognitive therapy | Other | 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. |
|
Measure the change in Goal Attainment Scaling calculation score at two different time points - 3 months and 6 months post brain injury. |
| Perform at 3 months (baseline) and 6 months (complete intervention) following mild traumatic brain injury |
| 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. |
| 26917201 | Background | 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. |
| 25871303 | Background | 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. |
| 24581903 | Background | 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. |
| 24581902 | Background | 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. |
| 23306011 | Background | 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. |
| 25559090 | Background | 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. |
| 19096970 | Background | 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. |
| 20146119 | Background | 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. |
| 31537559 | Derived | Hamzah N, Narayanan V, Ramli N, Mustapha NA, Mohammad Tahir NA, Tan LK, Danaee M, Muhamad NA, Drummond A, das Nair R, Goh SY, Mazlan M. Randomised controlled clinical trial of a structured cognitive rehabilitation in patients with attention deficit following mild traumatic brain injury: study protocol. BMJ Open. 2019 Sep 18;9(9):e028711. doi: 10.1136/bmjopen-2018-028711. |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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