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Brain Injuries clinical trials

View clinical trials related to Brain Injuries.

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NCT ID: NCT03450460 Completed - Clinical trials for Acquired Brain Injury

Ontario Brain Injury Association (OBIA) Peer Support Program

TOPS
Start date: May 16, 2018
Phase: N/A
Study type: Interventional

Most people with moderate or severe TBI have difficulty returning to their usual social roles and activities. The OBIA has developed a program where peers (other individuals living with TBI) coach or mentor those with more recent brain injury. The objective of this project is to evaluate the feasibility of measuring the impact of the OBIA Peer Program on social participation and mood compared to a control group who have not received peer support yet. The proposed study will involve three phases. It will begin with a qualitative component (stakeholder interviews), then a pilot RCT, and end with more interviews to explore the success of the study intervention. A qualitative descriptive approach will be used at these first and last phases of the study. In Phase 1, interviews will be conducted with approximately 15 participants including individuals with moderate to severe TBI, caregivers, Mentors, OBIA staff members, and health researchers. The proposed Phase 2 will be a clinical trial, conducted with 60 participants. These participants will be randomized to one of three groups: a twice a week Program (n=20), a once a week Program (n=20), or the wait list control group (n=20). For Phase 3, a sub group of approximately 25 participants from Phase 2 who participated in the OBIA Peer Support Program will be asked to participate in a one-on-one, telephone/Skype interview. A sub-group of Mentors will also be asked to participate in a one-on-one, telephone/Skype interview. This research project will address the highest priority areas of "strategies to enhance social participation and community life (personal relationships)" and "psychological strategies to improve mood, depression, and irritability", as identified in the ONF's Request for Proposals on "Addressing Evidence Gaps in Moderate to Severe TBI Rehabilitation". The study will provide important results to inform a RCT (of appropriate size) on the impact of peer support on the social participation and mood of individuals with moderate to severe TBI. This study will then provide the best evidence to support the recommendation on "a peer-supported relationship model of intervention", and inform future versions of the INESSS-ONF Guideline.

NCT ID: NCT03441867 Active, not recruiting - Epilepsy Clinical Trials

Neuroimaging Biomarker for Seizures

NIBMSZS
Start date: September 15, 2017
Phase: N/A
Study type: Interventional

This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging.

NCT ID: NCT03441776 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Towards Comparative Effectiveness in Military Vestibular Rehabilitation

Start date: February 9, 2018
Phase: N/A
Study type: Interventional

To prospectively evaluate the tools, environment and resources to compare the effectiveness of two different standard of care vestibular rehabilitation approaches in a military cohort with post-concussive vestibular symptoms.

NCT ID: NCT03438851 Terminated - Brain Injuries Clinical Trials

Assessing Brain Changes Throughout the ABI Wellness Program

Start date: March 7, 2018
Phase: N/A
Study type: Interventional

Symptoms resulting from mild/moderate trauma to the brain are as varied as the individuals who sustain them. The currently held belief is that the majority of healing and functional recovery occurs within the first two years post injury. A large proportion of individuals who sustain mild/moderate brain injuries (mTBIs) do not fully recover, and continue to experience symptoms well beyond two years post injury. Cognitive rehabilitation programs have been shown to be somewhat effective in helping mTBI patients regain some functionality in these executive domains. The purpose of the current study is to use an objective assessment of brain function to track changes during either a full-time or part-time holistic cognitive rehabilitation program, specifically the ABI Wellness (ABIW) program. The NeuroCatch Platform™ test will be used to assess brain functioning before, during and after 3 months in the ABIW program. The NeuroCatch Platform™ test uses electroencephalography (EEG) to measure event-related potential (ERP) signals produced by the brain, in response to an auditory stimulus. Three brain processes are examined with this test: Auditory sensation (ERP marker is the N100), Basic attention (ERP marker is the P300), and Cognitive processing (ERP marker is the N400).

NCT ID: NCT03438409 Terminated - Clinical trials for TBI (Traumatic Brain Injury)

Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate changes in response to robotic gait training in individuals with a traumatic brain injury.

NCT ID: NCT03430817 Completed - Intensive Care Unit Clinical Trials

Citicholine-Amantadine Trial in Traumatic Brain Injury

Start date: December 7, 2017
Phase: Phase 4
Study type: Interventional

This randomized study aims at comparing between the effects of amantadine, citcholine and its combinations on arousal and behavioral consequences in early phase of moderate Traumatic Brain injury (TBI).

NCT ID: NCT03429322 Completed - Clinical trials for Brain Injuries, Traumatic

Medical and Resource Facilitation Intervention After Traumatic Brain Injury

MRFI
Start date: January 11, 2019
Phase: N/A
Study type: Interventional

Mayo Clinic's Traumatic Brain Injury (TBI) Model System Center (TBIMSC) will capitalize on longstanding collaborations with the non-profit Minnesota Brain Injury Alliance (MN BIA) and Minnesota Department of Health (MDH) to test a new way of delivering medical and social services. This trial will address chronic unmet needs expressed by individuals with TBI and their families in the U.S. pertaining to the ineffective connection to specialized medical and community resources in the transition from hospital to community-based care, limited access to TBI experts, and lack of primary care provider (PCP) knowledge about the complex needs of individuals with TBI. Target populations for this study are: 1) individuals with TBI eligible for MN BIA provided Resource Facilitation (RF), 2) their families, and 3) their PCPs. This clinical trial will use a theory-driven complex behavioral intervention that integrates the medical-rehabilitation, therapy, and TBI expertise of Mayo's Brain Rehabilitation Clinic (BRC) with MN BIA's highly developed RF program (a free two-year telephone support service offering assistance in navigating life after brain injury). Mayo Clinic's medical-rehabilitation expertise will be integrated with RF services to deliver direct clinical care remotely using telemedicine and other information and communication technology to test whether outcomes over time are better in a group receiving this model of care compared to a group that receives usual care in their communities. Costs between usual care and intervention groups will be compared in collaboration with the MDH. The overarching goal is development of a replicable, sustainable, and cost effective model of telemedicine care that integrates TBIMS Centers and BIAs nationwide and builds TBI expertise and capacity among PCPs.

NCT ID: NCT03422276 Completed - Clinical trials for Traumatic Brain Injury

Brain Injury Rehabilitation Improving the Transition Experience

BRITE
Start date: February 13, 2018
Phase: N/A
Study type: Interventional

Each year, about 2.8 million people sustain a traumatic brain injury (TBI) in the United States, and at least 25 percent of these injuries are classified as moderate to severe. Nearly half of those hospitalized for TBI have long-term disability. Most have psychological, physical, social, or work-related problems, which often become chronic. By talking with patients and family members, we found that returning to daily activities and regaining quality of life are major concerns. Outcomes are affected by the type and severity of the TBI, but the type of treatment someone with TBI receives is also important. What resources are available, whether providers are experienced with the problems associated with TBI, and how much treatment is available can affect outcomes as well. Currently, inpatient rehabilitation professionals are told to give people with TBI information, reassurance, advice, and referral resources. Some promising ways of helping people with TBI include using telephone and other mobile devices to reach patients after they leave the hospital, to regularly assess their individual needs and help them coordinate their health care, and to provide the information and resources that they need. These new strategies may lead to earlier return to activities and improved quality of life. No studies have compared the standard approach to discharge care with an approach that uses telecare to provide information and care coordination after discharge from inpatient rehabilitation for TBI. The main goal of this project is to find out how improving the transition from the hospital to outpatient care can improve the lives of people with moderate to severe TBI and achieve better results that are important to patients with TBI, their families, and healthcare providers. In this study, patients with TBI who are discharged from inpatient rehabilitation at one of six national TBI Model Systems sites (University of Washington, Indiana University, Ohio State University, Mount Sinai Hospital, Moss Rehabilitation, and Baylor Institute for Rehabilitation) will be randomized (like the flip of a coin) to either the standard discharge plan or the standard discharge plan with additional telephone follow up from a TBI care manager for the first 6 months after discharge. The project team will compare patient and caregiver functioning and quality of life at 3, 6, 9, and 12 months after hospital discharge in these two groups.

NCT ID: NCT03421964 Completed - Clinical trials for Traumatic Brain Injury

Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability

Start date: February 16, 2018
Phase: N/A
Study type: Interventional

The aims of this traumatic brain injury (TBI) study are: 1. to evaluate the short and long-term efficacy of two structured outpatient intervention programs, Resilience and Adjustment Intervention (RAI) vs. RAI with follow up booster sessions (RAI+) on resilience 2. to evaluate the short and long-term impact of intervention on emotional well-being and postinjury adjustment with the RAI vs. the RAI+ 3. to evaluate the short and long-term impact of the RAI and the RAI+ on abilities including problem solving, communication, and stress management 4. to determine if demographic, lifestyle, injury, or treatment response information can predict maintenance of gains

NCT ID: NCT03418129 Completed - Chronic Pain Clinical Trials

Neuromodulatory Treatments for Pain Management in TBI

Start date: September 5, 2018
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) and chronic pain are common and serious health problems for military veterans and often co-occur, leading to poor post-deployment adjustment. Pharmacological treatments for pain elevate risk of opioid abuse, and research suggests veterans perceive barriers to existing non-pharmacological, clinic-based treatments. Thus, there is an urgent need to develop pain management approaches that are effective, overcome barriers to care, and are readily usable by Veterans. Evidence suggests that neuromodulatory treatments, grounded in understanding of neurophysiological mechanisms of pain, reduce pain-related symptoms and have the potential to be developed into self-directed treatments through use of mobile technology.