Training Communication Partners of People With Traumatic Brain Injury: Reporting the Protocol for a Clinical Trial

2009 ◽  
Vol 10 (2) ◽  
pp. 188-204 ◽  
Author(s):  
Leanne Togher ◽  
Skye McDonald ◽  
Robyn Tate ◽  
Emma Power ◽  
Rachel Rietdijk
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Delayed Treatment ◽  
Communication Partners ◽  
Severe Tbi ◽  
Injury Reporting ◽  
Everyday Communication

AbstractThis article reports on the design of a three-arm, nonrandomised controlled trial of interventions targeting social communication skills following traumatic brain injury (TBI) in adult participants. People with severe TBI were allocated to one of the three groups: the TBI group, where only the person with TBI was trained, the JOINT group where both the everyday communication partner (ECP) and the person with TBI were trained together, and a delayed treatment control condition. The trial is comparing whether including everyday communication partners in the training process provide additional benefit when compared to training the person with TBI alone; and additionally, whether training the person with TBI alone is more effective than no training. A range of primary and secondary outcome measures will be used to evaluate outcomes. Publishing the protocol prior to the results of the trial being available has several important benefits (Godlee, 2001). The original hypotheses and intentions of the research are made explicit to ensure that the process of conducting this clinical trial is transparent to readers, and so that comments may be made before results are finalised. It provides the opportunity to outline a detailed description of this intervention and methodology, or to acknowledge changes to methodology, which may assist with eventual clinical application of the intervention. This article also informs the research community of the work that is underway to promote opportunities for collaboration and reduce unnecessary duplication of research. The protocol for this trial has previously been registered on Current Controlled Trials (http://www.controlled-trials.com/ISRCTN57815281).

scholarly journals Do People With Severe Traumatic Brain Injury Benefit From Making Errors? A Randomized Controlled Trial of Error-Based and Errorless Learning

2017 ◽  
Vol 31 (12) ◽  
pp. 1072-1082 ◽  
Author(s):  
Tamara Ownsworth ◽  
Jennifer Fleming ◽  
Robyn Tate ◽  
Elizabeth Beadle ◽  
Janelle Griffin ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Psychosocial Functioning ◽  
Rating Scale ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Self Awareness ◽  
Errorless Learning ◽  
Meal Preparation ◽  
Severe Tbi

Background. Errorless learning (ELL) and error-based learning (EBL) are commonly used approaches to rehabilitation for people with traumatic brain injury (TBI). However, it is unknown whether making errors is beneficial in the learning process to promote skills generalization after severe TBI. Objective. To compare the efficacy of ELL and EBL for improving skills generalization, self-awareness, behavioral competency, and psychosocial functioning after severe TBI. Method. A total of 54 adults (79% male; mean age = 38.0 years, SD = 13.4) with severe TBI were randomly allocated to ELL or EBL and received 8 × 1.5-hour therapy sessions that involved meal preparation and other goal-directed activities. The primary outcome was total errors on the Cooking Task (near-transfer). Secondary outcome measures included the Zoo Map Test (far-transfer), Awareness Questionnaire, Patient Competency Rating Scale, Sydney Psychosocial Reintegration Scale, and Care and Needs Scale. Results. Controlling for baseline performance and years of education, participants in the EBL group made significantly fewer errors at postintervention (mean = 36.25; 95% CI = 32.5-40.0) than ELL participants (mean = 42.57; 95% CI = 38.8-46.3). EBL participants also demonstrated greater self-awareness and behavioral competency at postintervention than ELL participants ( P < .05). There were no significant differences on other secondary outcomes ( P > .05), or at the 6-month follow-up assessment. Conclusion. EBL was found to be more effective than ELL for enhancing skills generalization on a task related to training and improving self-awareness and behavioral competency.

scholarly journals The Effects of Repetitive Transcranial Magnetic Stimulation on Anxiety in Patients With Moderate to Severe Traumatic Brain Injury: A Post-hoc Analysis of a Randomized Clinical Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Priscila Aparecida Rodrigues ◽  
Ana Luiza Zaninotto ◽  
Hayden M. Ventresca ◽  
Iuri Santana Neville ◽  
Cintya Yukie Hayashi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Executive Function ◽  
Brain Injury ◽  
Transcranial Magnetic Stimulation ◽  
Magnetic Stimulation ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Anxiety Symptoms ◽  
Severe Tbi ◽  
Post Hoc

Background: Traumatic brain injury (TBI) is one of the leading causes of neuropsychiatric disorders in young adults. Repetitive Transcranial Magnetic Stimulation (rTMS) has been shown to improve psychiatric symptoms in other neurologic disorders, such as focal epilepsy, Parkinson's disease, and fibromyalgia. However, the efficacy of rTMS as a treatment for anxiety in persons with TBI has never been investigated. This exploratory post-hoc analyzes the effects of rTMS on anxiety, depression and executive function in participants with moderate to severe chronic TBI.Methods: Thirty-six participants with moderate to severe TBI and anxiety symptoms were randomly assigned to an active or sham rTMS condition in a 1:1 ratio. A 10-session protocol was used with 10-Hz rTMS stimulation over the left dorsolateral prefrontal cortex (DLPFC) for 20 min each session, a total of 2,000 pulses were applied at each daily session (40 stimuli/train, 50 trains). Anxiety symptoms; depression and executive function were analyzed at baseline, after the last rTMS session, and 90 days post intervention.Results: Twenty-seven participants completed the entire protocol and were included in the post-hoc analysis. Statistical analysis showed no interaction of group and time (p &gt; 0.05) on anxiety scores. Both groups improved depressive and executive functions over time, without time and group interaction (ps &lt; 0.05). No adverse effects were reported in either intervention group.Conclusion: rTMS did not improve anxiety symptoms following high frequency rTMS in persons with moderate to severe TBI.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02167971.

scholarly journals Acceptance and Commitment Therapy (ACT) for Psychological Adjustment after Traumatic Brain Injury: Reporting the Protocol for a Randomised Controlled Trial

2012 ◽  
Vol 13 (3) ◽  
pp. 360-376 ◽  
Author(s):  
Diane L. Whiting ◽  
Grahame K. Simpson ◽  
Hamish J. McLeod ◽  
Frank P. Deane ◽  
Joseph Ciarrochi
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Acceptance And Commitment Therapy ◽  
Controlled Trial ◽  
Consort Statement ◽  
Randomised Control Trial ◽  
Secondary Outcome ◽  
Adjustment Process ◽  
Commitment Therapy ◽  
Acceptance And Commitment

Following a severe traumatic brain injury (TBI) there is a complex presentation of psychological symptoms which may impact on recovery. Validated treatments addressing these symptoms for this group of people are limited. This article reports on the protocol for a single-centre, two-armed, Phase II Randomised Control Trial (RCT) to address the adjustment process following a severe TBI. Participants will be recruited from Liverpool Brain Injury Rehabilitation Unit and randomly allocated to one of two groups, Acceptance and Commitment Therapy (ACT) or an active control (Befriending). The active treatment group utilises the six core processes of ACT with the intention of increasing participation and psychological flexibility and reducing psychological distress. A number of primary and secondary outcome measures, administered at assessment, post-treatment and 1-month follow-up, will be used to assess clinical outcomes. The publication of the protocol before the trial results are available addresses fidelity criterion (intervention design) for RCTs. This ensures transparency in the RCT and that it meets the guidelines according to the CONSORT statement. The protocol has also been registered on the Australian New Zealand Clinical Trials Registry ACTRN12610000851066.

The effects of vestibular rehabilitation on dizziness and balance problems in patients after traumatic brain injury: a randomized controlled trial

2018 ◽  
Vol 33 (1) ◽  
pp. 74-84 ◽  
Author(s):  
Ingerid Kleffelgaard ◽  
Helene Lundgaard Soberg ◽  
Anne-Lise Tamber ◽  
Kari Anette Bruusgaard ◽  
Are Hugo Pripp ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Controlled Trial ◽  
Vestibular Rehabilitation ◽  
Secondary Outcome ◽  
Group Differences ◽  
Randomized Controlled ◽  
Balance Problems

Objective: To investigate the effects of group-based vestibular rehabilitation in patients with traumatic brain injury. Design: A single-blind randomized controlled trial. Setting: University Hospital (recruitment and baseline assessments) and Metropolitan University (experimental intervention). Subjects: A total of 65 patients (45 women) with mild-to-moderate traumatic brain injury (mean age 39.4 ± 13.0 years) were randomly assigned to intervention ( n = 33) or control group ( n = 32). Intervention: Group-based vestibular rehabilitation for eight weeks. Participants were tested at baseline (3.5 ± 2.1 months after injury) and at two post-intervention follow-ups (2.7 ± 0.8 and 4.4 ± 1.0 months after baseline testing). Main measures: Primary outcome: Dizziness Handicap Inventory. Secondary outcome: High-Level Mobility Assessment Tool. Other outcomes: Vertigo Symptom Scale; Rivermead Post-concussion Symptoms Questionnaire; Hospital Anxiety and Depression Scale; and Balance Error Scoring System. Between-group differences were analyzed with a linear mixed-model analysis for repeated measurements. Results: At baseline, no group differences were revealed (personal factors, clinical characteristics and outcome measures). At the first follow-up, statistically significant mean differences in favor of the intervention were found in the primary (−8.7, 95% confidence interval (CI): −16.6 to −0.9) and secondary outcomes (3.7 points, 95% CI: 1.4–6.0). At the second follow-up, no significant between-group differences were found. No significant between-group differences in the other outcomes were found at the two follow-ups. Conclusion: The intervention appeared to speed up recovery for patients with dizziness and balance problems after traumatic brain injury. However, the benefits had dissipated two months after the end of the intervention.

scholarly journals Guidelines for the Management of Severe Traumatic Brain Injury: 2020 Update of the Decompressive Craniectomy Recommendations

Neurosurgery ◽  
2020 ◽  
Vol 87 (3) ◽  
pp. 427-434 ◽  
Author(s):  
Gregory W J Hawryluk ◽  
Andres M Rubiano ◽  
Annette M Totten ◽  
Cindy O’Reilly ◽  
Jamie S Ullman ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Decompressive Craniectomy ◽  
Severe Traumatic Brain Injury ◽  
Controlled Trial ◽  
Outcome Data ◽  
The Body ◽  
Severe Tbi ◽  
Key Issues ◽  
New Evidence

Abstract When the fourth edition of the Brain Trauma Foundation's Guidelines for the Management of Severe Traumatic Brain Injury were finalized in late 2016, it was known that the results of the RESCUEicp (Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension) randomized controlled trial of decompressive craniectomy would be public after the guidelines were released. The guideline authors decided to proceed with publication but to update the decompressive craniectomy recommendations later in the spirit of “living guidelines,” whereby topics are updated more frequently, and between new editions, when important new evidence is published. The update to the decompressive craniectomy chapter presented here integrates the findings of the RESCUEicp study as well as the recently published 12-mo outcome data from the DECRA (Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury) trial. Incorporation of these publications into the body of evidence led to the generation of 3 new level-IIA recommendations; a fourth previously presented level-IIA recommendation remains valid and has been restated. To increase the utility of the recommendations, we added a new section entitled Incorporating the Evidence into Practice. This summary of expert opinion provides important context and addresses key issues for practitioners, which are intended to help the clinician utilize the available evidence and these recommendations. The full guideline can be found at: https://braintrauma.org/guidelines/guidelines-for-the-management-of-severe-tbi-4th-ed#/.

scholarly journals Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e040550
Author(s):  
Jean-Francois Payen ◽  
Marion Richard ◽  
Gilles Francony ◽  
Gérard Audibert ◽  
Emmanuel L Barbier ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Severe Traumatic Brain Injury ◽  
Life Assessment ◽  
Secondary Outcome ◽  
Trauma Patients ◽  
Brain Tissue Oxygenation ◽  
Severe Tbi ◽  
Randomised Controlled ◽  
The Impact

IntroductionIntracranial hypertension is considered as an independent risk factor of mortality and neurological disabilities after severe traumatic brain injury (TBI). However, clinical studies have demonstrated that episodes of brain ischaemia/hypoxia are common despite normalisation of intracranial pressure (ICP). This study assesses the impact on neurological outcome of guiding therapeutic strategies based on the monitoring of both brain tissue oxygenation pressure (PbtO2) and ICP during the first 5 days following severe TBI.Methods and analysisMulticentre, open-labelled, randomised controlled superiority trial with two parallel groups in 300 patients with severe TBI. Intracerebral monitoring must be in place within the first 16 hours post-trauma. Patients are randomly assigned to the ICP group or to the ICP + PbtO2 group. The ICP group is managed according to the international guidelines to maintain ICP≤20 mm Hg. The ICP + PbtO2 group is managed to maintain PbtO2 ≥20 mm Hg in addition to the conventional optimisation of ICP. The primary outcome measure is the neurological status at 6 months as assessed using the extended Glasgow Outcome Scale. Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days. Analysis will be performed according to the intention-to-treat principle and full statistical analysis plan developed prior to database freeze.Ethics and disseminationThis study has been approved by the Institutional Review Board of Sud-Est V (14-CHUG-48) and from the National Agency for Medicines and Health Products Safety (Agence Nationale de Sécurité du Médicament et des produits de santé) (141 435B-31). Results will be presented at scientific meetings and published in peer-reviewed publications.The study was registered with ClinTrials NCT02754063 on 28 April 2016 (pre-results).

scholarly journals Protocol for a Phase Two, Parallel Three-Armed Non-inferiority Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT-Adjust) Comparing Face-to-Face and Video Conferencing Delivery to Individuals With Traumatic Brain Injury Experiencing Psychological Distress

2021 ◽  
Vol 12 ◽  
Author(s):  
Diane L. Whiting ◽  
Grahame K. Simpson ◽  
Frank P. Deane ◽  
Sarah L. Chuah ◽  
Michelle Maitz ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Brain Injury ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Evidence Based ◽  
Face To Face ◽  
Randomized Controlled ◽  
Severe Tbi

Background: People with traumatic brain injury (TBI) face a range of mental health challenges during the adjustment process post-injury, but access to treatment can be difficult, particularly for those who live in regional and remote regions. eHealth provides the potential to improve access to evidence-based psychological therapy for people with a severe TBI. The aim of the current study is to assess the efficacy of a psychological intervention delivered via video consulting to reduce psychological distress in people with TBI.Methods: This paper outlines the protocol for a multi-center, three-arm, parallel, non-inferiority randomized controlled trial (RCT) of an evidence-based manualized psychological intervention, ACT-Adjust. ACT-Adjust provides nine sessions for adults with a moderate to severe TBI experiencing clinical levels of psychological distress. Fifty-six participants referred from Brain Injury Rehabilitation Units across New South Wales (NSW) and the NSW icare scheme will be randomly allocated to three conditions; (1) video consulting (VC), (2) face-to-face (FtF) and, (3) a waitlist control (WL).Discussion: This is the first RCT to evaluate the efficacy of a psychological therapy (ACT-Adjust) delivered via video consulting for individuals with a moderate to severe TBI.Trial Registration:www.anzctr.org.au, Australian New Zealand Clinical Trials Registry ANZCTRN2619001602112.

scholarly journals Factors associated with shunt-dependent hydrocephalus after decompressive craniectomy for traumatic brain injury

2018 ◽  
Vol 128 (5) ◽  
pp. 1547-1552 ◽  
Author(s):  
Aditya Vedantam ◽  
Jose-Miguel Yamal ◽  
Hyunsoo Hwang ◽  
Claudia S. Robertson ◽  
Shankar P. Gopinath
Keyword(s):  
Traumatic Brain Injury ◽  
Logistic Regression ◽  
Brain Injury ◽  
Decompressive Craniectomy ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Ventriculoperitoneal Shunting ◽  
Younger Age ◽  
Frontal Horn ◽  
Severe Tbi

OBJECTIVEPosttraumatic hydrocephalus (PTH) affects 11.9%–36% of patients undergoing decompressive craniectomy (DC) and is an important cause of morbidity after traumatic brain injury (TBI). Early diagnosis and treatment of PTH can prevent further neurological compromise in patients who are recovering from TBI. There is limited data on predictors of shunting for PTH after DC for TBI.METHODSProspectively collected data from the erythropoietin severe TBI randomized controlled trial were studied. Demographic, clinical, and imaging data were analyzed for enrolled patients who underwent a DC. All head CT scans during admission were reviewed and assessed for PTH by the Gudeman criteria or the modified Frontal Horn Index ≥ 33%. The presence of subdural hygromas was categorized as unilateral/bilateral hemispheric or interhemispheric. Using L1-regularized logistic regression to select variables, a multiple logistic regression model was created with ventriculoperitoneal shunting as the binary outcome. Statistical significance was set at p < 0.05.RESULTSA total of 60 patients who underwent DC were studied. Fifteen patients (25%) underwent placement of a ventriculoperitoneal shunt for PTH. The majority of patients underwent unilateral decompressive hemicraniectomy (n = 46, 77%). Seven patients (12%) underwent bifrontal DC. Unilateral and bilateral hemispheric hygromas were noted in 31 (52%) and 7 (11%) patients, respectively. Interhemispheric hygromas were observed in 19 patients (32%). The mean duration from injury to first CT scan showing hemispheric subdural hygroma and interhemispheric hygroma was 7.9 ± 6.5 days and 14.9 ± 11.7 days, respectively. The median duration from injury to shunt placement was 43.7 days. Multivariate analysis showed that the presence of interhemispheric hygroma (OR 63.6, p = 0.001) and younger age (OR 0.78, p = 0.009) were significantly associated with the need for a shunt after DC.CONCLUSIONSThe presence of interhemispheric subdural hygromas and younger age were associated with shunt-dependent hydrocephalus after DC in patients with severe TBI.

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