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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT06228872 Recruiting - Clinical trials for Traumatic Brain Injury

"Cognitive Rehabilitation With Direct Current Transcranial Stimulation in Post-Traumatic Brain Injury Patients"

tDCS-TEC
Start date: January 5, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the impact of daily self-administered transcranial direct current stimulation (tDCS) therapy on the cognitive function of individuals with moderate to severe cognitive impairment resulting from a traumatic brain injury (TBI). The study aims to answer the following questions: Does daily self-administered tDCS therapy, when combined with computerized cognitive training (CCT), improve cognitive function in TBI patients? Is CCT+tDCS with anodic stimulation more effective than CCT+tDCS with simulated stimulation in enhancing immediate and one-month post-treatment cognitive function? Does CCT+tDCS with anodic stimulation lead to better functionality immediately and one month after treatment compared to CCT+tDCS with simulated stimulation? Does CCT+tDCS with anodic stimulation have a positive impact on mood improvement immediately and one month after treatment compared to CCT+tDCS with simulated stimulation? Participants in the study will engage in CCT through a smartphone or tablet application and self-administer tDCS therapy for 20 minutes each day for a duration of one month. The tDCS therapy will involve applying a 2 mA anodic current to the prefrontal dorsolateral cortex (PFDL). Prior to the intervention, patients or their caregivers will receive training on the proper and safe usage of the tDCS device. Cognitive function, mood, and functionality will be evaluated before and after the intervention using appropriate measurement scales. The outcomes of this clinical trial have the potential to identify an effective and accessible therapeutic approach to enhance cognitive function in individuals with moderate to severe TBI. The combination of tDCS therapy with CCT offers an appealing and feasible treatment strategy for these patients, particularly when conducted in a home setting. The findings from this study will guide future clinical trials in the field of cognitive rehabilitation for TBI patients. Researchers will compare active tDCS with sham tDCS to determine if there are differences in the primary outcomes mentioned.

NCT ID: NCT06228391 Not yet recruiting - Clinical trials for Major Depressive Disorder

Ketamine Treatment for PTSD and MDD in TBI

Start date: March 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to examine the use of sedative ketamine to treat depression and post-traumatic stress disorder (PTSD) in Veterans with mild to moderate traumatic brain injury (TBI). The main questions it aims to answer are: - Efficacy of ketamine to reduce symptoms of depression and/or PTSD - Safety of ketamine to treat depression and/or PTSD in TBI Participants will be randomly assigned to receive either ketamine or midazolam (active placebo) twice a week for 3 weeks. During participation, subjects will be interviewed, have lab tests, and complete rating scales, and questionnaires.

NCT ID: NCT06228170 Withdrawn - Clinical trials for Traumatic Brain Injury

Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients

SGB-TBI
Start date: January 30, 2024
Phase: N/A
Study type: Interventional

The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are: Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients. Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

NCT ID: NCT06222502 Recruiting - Clinical trials for Traumatic Brain Injury

Walking After Traumatic Brain Injury in Older Adults

Start date: January 16, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to test the effect of a planning, reminders, and micro-incentives intervention verses regular health education facts on physical activity participation over 12-weeks, in older adults who have previously suffered a non-penetrating mild or moderate TBI. Participants will provide information and be screened for eligibility via phone screening call (verification of age, confirmation that the participant is not currently on any medication that affects the central nervous system, and verification that the subject can participate in exercise, brief TBI history). Baseline testing will take place at the Center for Cognitive and Brain Health and Northeastern University Biomedical Imaging Center, for the baseline magnetic resonance imaging, in the interdisciplinary science and engineering complex on Northeastern University's campus. In person testing will take place over one session. The study period lasts 12 weeks, during which all participants will 1. Receive a weekly phone call with study staff, 2. Wear a wrist-worn Fit Bit tracker and 3. Record their weekly walking activities.

NCT ID: NCT06222450 Not yet recruiting - Clinical trials for Mild Traumatic Brain Injury

Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare outcomes for standard vestibular rehabilitation home program to a digital vestibular rehabilitation home program in adults with dizziness related to mild traumatic brain injury (mTBI). The main question is whether participants who use the digital format of vestibular rehabilitation improve to a greater extent at discharge than those who use the standard format. Participants will undergo a customized vestibular rehabilitation home exercise program per standard of care, consisting of gaze stabilization, habituation, balance and gait exercises, and endurance training under the supervision of a physical therapist. Participants will complete the gaze stabilization and habituation exercises 2-3 times per day and the balance and gait exercises 1 time per day for 4 weeks. Participants will be tested before and after the 4-week intervention. At the initial session, the researcher will perform standard clinical tests of the inner ear balance system. Also at the initial session, the researcher will perform standard clinical tests of balance and walking and questionnaires about the impact of dizziness on daily activities. At the final session, the researcher will repeat the tests of balance and walking and questionnaires. Three months after completing the intervention participants will complete an online questionnaire about the impact of dizziness on daily activities.

NCT ID: NCT06221215 Recruiting - Clinical trials for Brain Injury Traumatic Diffuse With Loss of Consciousness

Clinical Analysis of Early Hormones Between Patients With Traumatic Brain Injury and Cerebral Hemorrhage

Start date: October 1, 2023
Phase:
Study type: Observational [Patient Registry]

Our understanding of neurosecretory dysfunction after TBI is still insufficient, and the number of patients with neuroendocrine dysfunction caused by craniocerebral trauma may be underestimated, especially the neuroendocrine changes related to HPA axis in the early stage after craniocerebral trauma. Moreover, there are few and fragmentary literature data on the benefits of hormone replacement therapy in patients with neuroendocrine disorders after traumatic brain injury. This requires more studies to further determine the characteristics of pituitary function or hormone disorders in the early stage after traumatic brain injury, which makes it necessary for us to further study the neuroendocrine dysfunction (hormone disorder) in the early stage after craniocerebral injury. To explore the relationship between craniocerebral injury and early hormone disorder by measuring the changes of early hormone levels in patients with TBI is of great significance for the early detection of related complications after craniocerebral injury and the evaluation of the prognosis of patients with craniocerebral injury, and can provide a new diagnosis and treatment plan for early intervention of related complications after TBI.

NCT ID: NCT06217575 Not yet recruiting - Aging Clinical Trials

Brain Research Assessing Impacts of Neurophysiological Processing Speed Training in Veterans

BRAIN-SPEED
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Older veterans with a history of mild brain trauma exhibit early cognitive challenges, especially in driving-related tasks. This is attributed to alterations in the brain's excitatory/inhibitory (E/I) balance. This pilot project investigates this phenomenon by leveraging electroencephalography (EEG) to measure parietal lobe alpha rhythms during visual attention tasks. The hypothesis is that targeted visual attention training can modulate these alpha rhythms, improving instrumental activities in daily life. However, outcomes from such training vary, possibly due to individual differences in cortical inhibitory functions. This study will assess the relationship between EEG measures of E/I balance pre- and post-visual attention training and its effects on processing speeds in aging veterans. Our findings aim to provide a foundation for customized therapies and interventions for veterans with and without a history of brain trauma.

NCT ID: NCT06214364 Not yet recruiting - Cerebral Palsy Clinical Trials

Transcranial Direct Current Stimulation and Gamified Rehabilitation for Upper Limb Function in Pediatric Brain Damage

Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to acknowledge the effects of transcranial direct current stimulation as an adjuvant with gaming rehabilitation for upper limb function rehabilitation in paediatric population with non-progressive brain damage. The main questions it aims to answer are: - Does tDCS boost upper limb function rehabilitation results adding as an adjuvant in paediatric brain damage? - What domains related with upper limb function are most influenced by tDCS stimulation? - What clinical variables are the best to predict the efficacy of the combined treatment? - If the selected intervention causes changes in cognitive domains, and, if it occurs, see their relationship with the proposed intervention and the motor outcomes. As a general objective, this trial seeks the validation of a protocol of non-invasive brain stimulation with tDCS as a complementary therapy for peadiatric population with brain injuries. Participants will be randomly allocated into two groups: experimental group will receive anodal tDCS plus upper limb rehabilitation gaming system rehabilitation and control group will receive sham tDCS plus rehabilitation gaming system for upper limb rehabilitation. Both groups will conducted a virtual reality program with upper limb exercises while been stimulated either with anodal tDCS or sham tDCS. Researchers will compare experimental and control groups to see if there is a difference in upper limb function and cognitive functions.

NCT ID: NCT06207591 Recruiting - Clinical trials for Traumatic Brain Injury

Investigation on the Cortical Communication System

CortiCom
Start date: December 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to demonstrate communication through a brain implant in people in locked-in state, i.e. people with severe paralysis and communication problems. The main questions it aims to answer are efficient and stable control of Brain-Computer interface (BCI) functions for communication with attempted hand movements and operation of a keyword-based speech BCI. Participants will be implanted with four electrode grids, with in total 128 electrodes, on the surface of the brain and a connector on the skull. Participation includes visits of researchers for recording and training at home, 2-3 times per week for one year. Extension of participation after one year is possible. If successful, the participant will be able to use the BCI at home independently, without the presence of a researcher.

NCT ID: NCT06199778 Terminated - Clinical trials for Traumatic Brain Injury

Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy

STBI
Start date: June 1, 2022
Phase: N/A
Study type: Interventional

This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.