The Effect of Cognitive Rehabilitation Therapy in Improving Cognitive Function of Attention Following Mild Traumatic Brain Injury
NCT ID: NCT03237676
Last Updated: 2020-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2017-08-01
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Cognitive outcome assessor is blinded from knowing which participant receives which treatment arm.
Study Groups
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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).
Structured cognitive rehabilitation therapy
A computer-based cognitive rehabilitation therapy Therapy frequency is one hour session per week for three months.
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).
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.
Interventions
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Structured cognitive rehabilitation therapy
A computer-based cognitive rehabilitation therapy Therapy frequency is one hour session per week for three months.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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University of Malaya
OTHER
Responsible Party
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Principal Investigators
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Norhamizan Hamzah, MBChB,MRehabMed
Role: PRINCIPAL_INVESTIGATOR
Rehabilitation Medicine Specialist, University of Malaya
Mazlina Mazlan, MBBS,MRehabMed
Role: STUDY_CHAIR
Consultant Rehabilitation Medicine & Associate Professor, University of Malaya
Vairavan Narayanan, MBBS,MSURG,FRCS
Role: STUDY_CHAIR
Consultant Neurosurgeon & Associate Professor, University of Malaya
Norlisah Ramli, MBBS,FRCR
Role: STUDY_CHAIR
Consultant Neuroradiologist & Professor, University of Malaya
Locations
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University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PO037-2015A
Identifier Type: -
Identifier Source: org_study_id