Traumatic Brain Injury Clinical Trial
Official title:
Biomarkers of Thalamic LIFUP in Chronic Disorders of Consciousness
When patients survive a severe brain injury but fail to fully recover, they often enter a Disorder of Consciousness (DoC) --that is, a set of related conditions of decreased awareness and arousal including the Vegetative State (VS) and the Minimally Conscious State (MCS). When these conditions become chronic, there are no approved treatments to help bolster any further recovery. In prior work, we have shown the clinical feasibility and potential of Low Intensity Focused Ultrasound Pulsation (LIFUP) as a remarkably safe form of non-invasive brain stimulation in these conditions.
In the present study, we propose taking the "next step" to assess whether LIFUP can affect objective and validated markers of DoC patient impairment (in the direction of lesser impairment). Specifically, patients will be admitted at Casa Colina Hospital for a 10-day (in-patient) protocol, and two follow-up sessions, conducted remotely (e.g., over the phone) at 7 and 30-days post-discharge. The full length of the study is 40 days from admission. Over the admission period, patients will undergo multiple measurements of validated biomarkers, including behavioral testing, brain metabolism (using Positron Emission Tomography), and electroencephalography, before and after one session of LIFUP to thalamus. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
| Recruiting |
NCT05503316 -
The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
|
N/A | |
| Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
| Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
| Terminated |
NCT03698747 -
Myelin Imaging in Concussed High School Football Players
|
||
| Recruiting |
NCT05130658 -
Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training
|
N/A | |
| Recruiting |
NCT04560946 -
Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI
|
N/A | |
| Completed |
NCT05160194 -
Gaining Real-Life Skills Over the Web
|
N/A | |
| Recruiting |
NCT02059941 -
Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines
|
N/A | |
| Recruiting |
NCT03940443 -
Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
|
||
| Recruiting |
NCT03937947 -
Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
|
||
| Completed |
NCT04465019 -
Exoskeleton Rehabilitation on TBI
|
||
| Recruiting |
NCT04530955 -
Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)
|
N/A | |
| Recruiting |
NCT03899532 -
Remote Ischemic Conditioning in Traumatic Brain Injury
|
N/A | |
| Suspended |
NCT04244058 -
Changes in Glutamatergic Neurotransmission of Severe TBI Patients
|
Early Phase 1 | |
| Completed |
NCT03307070 -
Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
|
N/A | |
| Recruiting |
NCT04274777 -
The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
|
||
| Withdrawn |
NCT05062148 -
Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
|
N/A | |
| Withdrawn |
NCT04199130 -
Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI
|
N/A | |
| Withdrawn |
NCT03626727 -
Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
|
Early Phase 1 |