Protocol for a clinical trial of telehealth-based social communication skills training for people with traumatic brain injury and their communication partners

2019 ◽  
Vol 21 (1) ◽  
pp. 110-123 ◽  
Author(s):  
Rachael Rietdijk ◽  
Emma Power ◽  
Melissa Brunner ◽  
Leanne Togher
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Training Group ◽  
Historical Control Group ◽  
Historical Control ◽  
Control Group ◽  
Communication Partner ◽  
Communication Partners ◽  
Communication Partner Training

AbstractBackground: A previous clinical trial of training communication partners of people with traumatic brain injury (TBI) demonstrated positive outcomes [Togher, Power, McDonald, Tate, & Rietdijk (2009). Brain Impairment, 10(2), 188-204]. Adapting communication partner training for delivery via telehealth could improve access to this intervention.Objectives: To compare outcomes across in-person communication partner training, telehealth communication partner training and a control groupMethod: Protocol for a partially randomised controlled trial. People with moderate-severe TBI will be allocated to either an in-person or telehealth-based training program. Comparison data will be drawn from the original trial control group, which was recruited using the same eligibility criteria as this protocol. Outcomes after training will be compared between the in-person training group, the telehealth training group and the historical control group.Discussion: This protocol uses specific design features with the aim of maximising the study’s power, including a partially randomised allocation process and a historical control group. The results will inform about the feasibility and effectiveness of delivering TBI rehabilitation via telehealth.Trial registration: Australian and New Zealand Clinical Trials Registry: ACTRN12615001024538.

scholarly journals Evaluation of the Effect of Atorvastatin Administration on the Outcomes of Patients with Traumatic Brain Injury: A Double-Blinded Randomized Clinical Trial

2021 ◽  
Vol 11 (4) ◽  
Author(s):  
Farhad Soltani ◽  
Farahzad Janatmakan ◽  
Sara Jorairahmadi ◽  
Fatemeh Javaherforooshzadeh ◽  
Pooyan Alizadeh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Randomized Clinical Trial ◽  
Rating Scale ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Disability Rating Scale ◽  
Double Blinded

Background: Traumatic brain injury (TBI) is one of the common causes of long-term disabilities and mortality. This study aimed to evaluate the effect of atorvastatin administration on the Glasgow Coma Scale (GCS), Glasgow Outcome Scale (GOS), and Disability Rating Scale (DRS) in patients with TBI. Methods: This double-blinded randomized clinical trial included 60 patients with TBI in Golestan Hospital of Ahvaz, Iran. After obtaining an informed consent from all patients, the patients were randomly assigned into two groups. For the intervention group, atorvastatin with a daily dose of 20 mg was used. The control group was administered the same amount of placebo for 10 days. Changes in the level of consciousness were measured using the GCS, and functional recovery rate in patients was measured by GOS and DRS in the third follow-up month. Results: According to the obtained results, compared with the control group, the atorvastatin administration significantly increased the level of GCS and DRS within 2 - 3 months post-intervention and improved GOS since the tenth day after the study (P < 0.05). Conclusions: The results revealed the positive effect of atorvastatin on the improvement of outcomes measurements such as GCS, DRS, and GOS in patients after moderate and severe TBI.

scholarly journals A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury

2013 ◽  
Vol 118 (6) ◽  
pp. 1317-1328 ◽  
Author(s):  
Sarah B. Rockswold ◽  
Gaylan L. Rockswold ◽  
David A. Zaun ◽  
Jiannong Liu
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Intracranial Pressure ◽  
Clinical Outcome ◽  
Severe Traumatic Brain Injury ◽  
Standard Care ◽  
Cerebral Metabolism ◽  
Control Group ◽  
Normobaric Hyperoxia

Object Preclinical and clinical investigations indicate that the positive effect of hyperbaric oxygen (HBO2) for severe traumatic brain injury (TBI) occurs after rather than during treatment. The brain appears better able to use baseline O2 levels following HBO2 treatments. In this study, the authors evaluate the combination of HBO2 and normobaric hyperoxia (NBH) as a single treatment. Methods Forty-two patients who sustained severe TBI (mean Glasgow Coma Scale [GCS] score 5.7) were prospectively randomized within 24 hours of injury to either: 1) combined HBO2/NBH (60 minutes of HBO2 at 1.5 atmospheres absolute [ATA] followed by NBH, 3 hours of 100% fraction of inspired oxygen [FiO2] at 1.0 ATA) or 2) control, standard care. Treatments occurred once every 24 hours for 3 consecutive days. Intracranial pressure, surrogate markers for cerebral metabolism, and O2 toxicity were monitored. Clinical outcome was assessed at 6 months using the sliding dichotomized Glasgow Outcome Scale (GOS) score. Mixed-effects linear modeling was used to statistically test differences between the treatment and control groups. Functional outcome and mortality rates were compared using chi-square tests. Results There were no significant differences in demographic characteristics between the 2 groups. In comparison with values in the control group, brain tissue partial pressure of O2 (PO2) levels were significantly increased during and following combined HBO2/NBH treatments in both the noninjured and pericontusional brain (p < 0.0001). Microdialysate lactate/pyruvate ratios were significantly decreased in the noninjured brain in the combined HBO2/NBH group as compared with controls (p < 0.0078). The combined HBO2/NBH group's intracranial pressure values were significantly lower than those of the control group during treatment, and the improvement continued until the next treatment session (p < 0.0006). The combined HBO2/NBH group's levels of microdialysate glycerol were significantly lower than those of the control group in both noninjured and pericontusional brain (p < 0.001). The combined HBO2/NBH group's level of CSF F2-isoprostane was decreased at 6 hours after treatment as compared with that of controls, but the difference did not quite reach statistical significance (p = 0.0692). There was an absolute 26% reduction in mortality for the combined HBO2/NBH group (p = 0.048) and an absolute 36% improvement in favorable outcome using the sliding dichotomized GOS (p = 0.024) as compared with the control group. Conclusions In this Phase II clinical trial, in comparison with standard care (control treatment) combined HBO2/NBH treatments significantly improved markers of oxidative metabolism in relatively uninjured brain as well as pericontusional tissue, reduced intracranial hypertension, and demonstrated improvement in markers of cerebral toxicity. There was significant reduction in mortality and improved favorable outcome as measured by GOS. The combination of HBO2 and NBH therapy appears to have potential therapeutic efficacy as compared with the 2 treatments in isolation. Clinical trial registration no.: NCT00170352 (ClinicalTrials.gov).

scholarly journals The Effect of Low-Dose Atorvastatin on Inflammatory Factors in Patients with Traumatic Brain Injury: A Randomized Clinical Trial

2020 ◽  
Vol 7 (4) ◽  
Author(s):  
Farhad Soltani ◽  
Nozar Nassajian ◽  
Kamalodin Tabatabaee ◽  
Fatemeh Javaherforooshzadeh ◽  
Arash Kiani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Glasgow Coma Score ◽  
Blood Cells ◽  
Low Dose ◽  
White Blood Cells ◽  
Inflammatory Factors ◽  
Control Group ◽  
Atorvastatin Group

Background: Traumatic brain injury (TBI) is the leading cause of morbidity and mortality. Each year near 1.5 million Americans experience a TBI. Of which about 235,000 are hospitalized. Also, TBI claims 50 000 American lives each year. TBI causes mechanical damage to the blood-brain barrier and white blood cells (WBCs) entry to the brain. Objectives: The current study aimed to evaluate the efficacy of low-dose Atorvastatin on inflammatory factors in patients with traumatic brain injury (TBI). Methods: This double-blind, randomized clinical trial study was conducted in the ICU ward of Golestan Hospital in the city of Ahvaz (Iran) from April 2019-May 2020. Sixty patients with moderate to severe TBI were studied. Patients were randomly assigned into two groups of Atorvastatin and control. The main outcomes included the amount of CRP and ESR as well as white blood cells in the first 14 days of hospitalization. Glasgow Coma Score, the length of ICU stay, and the duration of mechanical ventilation were secondary outcomes. Results: The amount of CRP in the Atorvastatin group on the 14th day of hospitalization was significantly lower than those in the control group (31.99 ± 8.38 vs 59.65 ± 10.43) (P < 0.0001). On the same day, the Atorvastatin group had lower levels of ESR than the control group (14.28 ± 4.18 vs 25.57 ± 5.18) (P < 0.0001). The Atorvastatin group had significantly lower levels of white blood cells than the control group (5247.53 ± 751.93 vs 7143.94 ± 907.64, P < 0.0001). Glasgow Coma Score at the time of discharge from the ICU in the Atorvastatin group was more than control (14.06 ± 1.45 and 11.85 ± 0.75, respectively) (P < 0.05). A significant difference was found concerning the ICU stay between the two groups (P = 0.03). Conclusions: This study demonstrated that Atorvastatin could reduce the rate of inflammatory factors in TBI patients. The inflammatory condition of TBI patients heavily determines their prognosis. Inflammation leads to several reactions as well as interactions between different cells and chemical mediators. The Atorvastatin could reduce the rate of inflammatory factors and improved GCS in TBI patients.

scholarly journals Early Orthostatic Exercise by Head-Up Tilt With Stepping vs. Standard Care After Severe Traumatic Brain Injury Is Feasible

2021 ◽  
Vol 12 ◽  
Author(s):  
Christian Gunge Riberholt ◽  
Markus Harboe Olsen ◽  
Christian Baastrup Søndergaard ◽  
Christian Gluud ◽  
Christian Ovesen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Adverse Events ◽  
Severe Traumatic Brain Injury ◽  
Standard Care ◽  
Randomized Clinical Trials ◽  
Neurointensive Care ◽  
Control Group ◽  
Neurointensive Care Unit

Background: Intensive rehabilitation of patients after severe traumatic brain injury aims to improve functional outcome. The effect of initiating rehabilitation in the early phase, in the form of head-up mobilization, is unclear.Objective: To assess whether early mobilization is feasible and safe in patients with traumatic brain injury admitted to a neurointensive care unit.Methods: This was a randomized parallel-group clinical trial, including patients with severe traumatic brain injury (Glasgow coma scale &lt;11 and admission to the neurointensive care unit). The intervention consisted of daily mobilization on a tilt-table for 4 weeks. The control group received standard care. Outcomes were the number of included participants relative to all patients with traumatic brain injury who were approached for inclusion, the number of conducted mobilization sessions relative to all planned sessions, as well as adverse events and reactions. Information on clinical outcome was collected for exploratory purposes.Results: Thirty-eight participants were included (19 in each group), corresponding to 76% of all approached patients [95% confidence interval (CI) 63–86%]. In the intervention group, 74% [95% CI 52–89%] of planned sessions were carried out. There was no difference in the number of adverse events, serious adverse events, or adverse reactions between the groups.Conclusions: Early head-up mobilization is feasible in patients with severe traumatic brain injury. Larger randomized clinical trials are needed to explore potential benefits and harms of such an intervention.Clinical Trial Registration: [ClinicalTrials.gov], identifier [NCT02924649]. Registered on 3rd October 2016.

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).

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