Clinical Trials

Clinical Trial – The Role of Hyperbaric Oxygen and Neuropsychological Therapy in Cognitive Function Following Traumatic Brain Injury

Traumatic brain injury (TBI) caused by accidents is a very important public health problem in
Taiwan. There are many people with brain damage and cognitive dysfunction caused by traumatic
brain injury every year. Currently, there is no effective treatment for cognitive dysfunction
caused by traumatic brain injury. Evidence from clinical studies in recent years suggests
that hyperbaric oxygen therapy may be a treatment for repairing nerves after brain injury.

Many studies have shown that oxidative stress and inflammatory responses play an important
role in the pathogenesis of the central nervous system. In recent years, our research team
has shown that oxidative stress and inflammatory response are significantly associated with
the prognosis of patients with traumatic brain injury, cerebral hemorrhage, and stroke
patients. More and more evidences also show that oxidative stress and inflammatory response
play an important role in the neuropathological changes of mental cognitive sequelae after
traumatic brain injury. This injury may be gradual from the time of head trauma. This process
begins with the generation of oxidative stress and free radicals. When the cell repair and
free radical scavenging system can not effectively overcome the excessive production of free
radicals, an oxidative damage reaction will occur, causing a series of inflammatory cells and
cytokines to be activated. Studies have also shown that when inhibiting those free radicals
that produce oxidative stress, the neurological function and cognitive function of the head
after trauma can be significantly improved.

It is becoming widely acknowledged that the combined action of hyperoxia and hyperbaric
pressure leads to significant improvement in tissue oxygenation while targeting both
oxygenand pressure-sensitive genes, resulting in improved mitochondrial metabolism with
anti-apoptotic and anti-inflammatory effects. The investigators published an article this
year showing that hyperbaric oxygen therapy can improve the prognosis of patients with acute
stroke and increase endothelial progenitor cells in the systemic circulation.

The investigators plan to conduct this research project through hyperbaric oxygen therapy and
neuropsychological therapy, and using scientific tests and neurocognitive function
assessments. The investigators hope to answer the following questions: (1) Whether the
treatment of hyperbaric oxygen can improve oxidative stress and inflammatory response after
brain injury, and observe changes in biomarker concentration; (2) Whether hyperbaric oxygen
therapy and neuropsychological therapy can improve cognitive function after brain injury; and
(3) which biomarkers are factors that influence cognitive function prognosis.

Clinical Trial – Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery

This is a multicenter, randomized, double-blind, active-controlled study to evaluate the
non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in
lower limbs vascular surgery.

The schedule consists of three visits: screening (visit 1); pre-anesthetic evaluation and
randomization (visit 2); treatment, and discharge from study (visit 3).

Clinical Trial – Anti Inflammatory Effects of Local Cryotherapy in Knee Arthritis

47 patients with non-septic knee arthritis were treated by local ice (30 min) or cold CO2 (2
min) twice at an 8 hour-interval for 1 day.

The synovial fluid was collected just before the first cold application then 24 hours later.

Cytokine, VEGF, NF-kB, PG-E2 levels were assessed in the synovial fluid before/after
treatment.

Contralateral arthritic knees were used as paired controls when possible.

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