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

NCT03237676 | Completed DMC

• 1 other identifier: PO037-2015A
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Traumatic Brain Injury; Cognitive Impairment

Keywords

cognitive rehabilitation; diffusion tensor imaging; neuropsychology; functional outcome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in Diffusion Tensor Imaging parameters

  Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury

• Change in Goal Attainment Scaling score

  Perform at 3 months (baseline) and 6 months (complete intervention) following mild traumatic brain injury

Study Arms (2)

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).

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).

Other: Patient-centred cognitive therapy

Interventions

Structured cognitive rehabilitation therapy OTHER

A computer-based cognitive rehabilitation therapy Therapy frequency is one hour session per week for three months.

Also known as: cognitive therapy, CogniPlus

Individualised structured cognitive rehabilitation therapy

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.

Patient-centred cognitive therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (11)

• 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 BACKGROUND

• 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 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.

  PMID: 26917201 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.

  PMID: 25871303 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.

  PMID: 24581903 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.

  PMID: 24581902 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.

  PMID: 23306011 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.

  PMID: 25559090 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.

  PMID: 19096970 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.

  PMID: 20146119 BACKGROUND

• 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.

  PMID: 31537559 DERIVED

MeSH Terms

Conditions

Brain Concussion; Cognitive Dysfunction

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: intervention group receives structured cognitive rehabilitation therapy, control group receives conventional/pre-existing cognitive rehabilitation therapy.

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: August 2, 2017
• Study Start: August 1, 2017
• Primary Completion: April 30, 2019
• Study Completion: December 31, 2019
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

MY (1)