Mild Traumatic Brain InjuryNCT03237676
The Effect of Cognitive Rehabilitation Therapy in Improving Cognitive Function of Attention Following Mild Traumatic Brain Injury
A study testing Structured cognitive rehabilitation therapy and Patient-centred cognitive therapy in people with Mild Traumatic Brain Injury and Cognitive Impairment, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mild Traumatic Brain Injury, Cognitive Impairment
- What is being tested?
- Structured cognitive rehabilitation therapy and Patient-centred cognitive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
About this study
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).
Read the 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:
- 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.
- 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:
- Neuropsychological Assessment Battery-Screening test
- Diffusion Tensor Imaging parameters
- 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:
- Mild traumatic brain injury control group, and
- Mild traumatic brain injury intervention group.
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.
- Conditions
- Mild Traumatic Brain Injury, Cognitive Impairment
- Being tested
- Structured cognitive rehabilitation therapy, Patient-centred cognitive therapy
- Keywords
- cognitive rehabilitation, diffusion tensor imaging, neuropsychology, functional outcome
- Medical subject headings
- Brain Concussion, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured cognitive rehabilitation therapyOther
Also called cognitive therapy, CogniPlus
A computer-based cognitive rehabilitation therapy Therapy frequency is one hour session per week for three months.
Patient-centred cognitive therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Structured cognitive rehabilitation therapy |
| 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). Receives: Other: Patient-centred cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury
Secondary outcomes (2)
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.
Measured: Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury
Change in Goal Attainment Scaling score
Measure the change in Goal Attainment Scaling calculation score at two different time points - 3 months and 6 months post brain injury.
Measured: Perform at 3 months (baseline) and 6 months (complete intervention) following mild traumatic brain injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Aug 2017
- Primary completion30 Apr 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention group receives structured cognitive rehabilitation therapy, control group receives conventional/pre-existing cognitive rehabilitation therapy.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norhamizan Hamzah, MBChB,MRehabMed, Principal investigator, Rehabilitation Medicine Specialist, University of MalayaMazlina Mazlan, MBBS,MRehabMed, Study chair, Consultant Rehabilitation Medicine & Associate Professor, University of MalayaVairavan Narayanan, MBBS,MSURG,FRCS, Study chair, Consultant Neurosurgeon & Associate Professor, University of MalayaNorlisah Ramli, MBBS,FRCR, Study chair, Consultant Neuroradiologist & Professor, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237676
- Sponsor's protocol ID
- PO037-2015A
- Status last verified
- Nov 2020
- First submitted
- 18 Jul 2017
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25952562Veeramuthu 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.
PubMed 27751922Veeramuthu 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.
PubMed 26917201Marshall 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.
PubMed 25871303Carroll 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.
PubMed 24581903Cassidy 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.
PubMed 24581902Hulkower 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.
PubMed 23306011das 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.
PubMed 25559090Temple 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.
PubMed 19096970Zgaljardic 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.
PubMed 20146119Hamzah 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.
PubMed 31537559
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Rehabilitation Therapy in Improving Cognitive Function of Attention Following Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03237676
- Acronym / sponsor ID
- PO037-2015A
- Conditions
- Mild Traumatic Brain Injury, Cognitive Impairment
- Keywords
- cognitive rehabilitation, diffusion tensor imaging, neuropsychology, functional outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- Neuropsychological Assessment Battery-Screening test
- Diffusion Tensor Imaging parameters
- 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:
- Mild traumatic brain injury control group, and
- Mild traumatic brain injury intervention group.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- intervention group receives structured cognitive rehabilitation therapy, control group receives conventional/pre-existing cognitive rehabilitation therapy.
| Arm | Type | Receives |
|---|---|---|
| Individualised structured cognitive rehabilitation therapy | Experimental | Other: Structured cognitive rehabilitation therapyParticipants 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 | Other: Patient-centred cognitive therapyParticipants of conventional arm will receive an existing cognitive rehabilitation treatment available at the proposed health centre (University Malaya Medical Centre, Malaysia). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured cognitive rehabilitation therapyAlso: cognitive therapy, CogniPlusA computer-based cognitive rehabilitation therapy Therapy frequency is one hour session per week for three months. | Other | Individualised structured cognitive rehabilitation therapy |
| Patient-centred cognitive therapyApplication 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 | Patient-centred cognitive therapy |
Primary outcome
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.
2 secondary outcomes
Change in Diffusion Tensor Imaging parameters
Time frame: Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury
Change in Goal Attainment Scaling score
Time frame: Perform at 3 months (baseline) and 6 months (complete intervention) following mild traumatic brain injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Background: PubMed 25952562Veeramuthu 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.
- Background: PubMed 27751922Veeramuthu 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.
- Background: PubMed 26917201Veeramuthu 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.
- Background: PubMed 25871303Marshall 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.
- Background: PubMed 24581903Carroll 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.
- Background: PubMed 24581902Cassidy 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.
- Background: PubMed 23306011Hulkower 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.
- Background: PubMed 25559090das 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.
- Background: PubMed 19096970Temple 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.
- Background: PubMed 20146119Zgaljardic 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.
- Derived from this study: PubMed 31537559Hamzah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norhamizan Hamzah, MBChB,MRehabMed principal investigator
Rehabilitation Medicine Specialist, University of Malaya
Mazlina Mazlan, MBBS,MRehabMed study chair
Consultant Rehabilitation Medicine & Associate Professor, University of Malaya
Vairavan Narayanan, MBBS,MSURG,FRCS study chair
Consultant Neurosurgeon & Associate Professor, University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured cognitive rehabilitation therapy and Patient-centred cognitive therapy in people with Mild Traumatic Brain Injury and Cognitive Impairment, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03237676, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020; AzTrials last refreshed its copy on 31 Oct 2026.