Clinical Trials Logo

Clinical Trial Summary

Concussion is the most common type of brain injury throughout life. Study is seeking improvement of long-term residua following adolescent and adult post-traumatic injuries often associated with contact sports and accidental causes. Typically defined as reversible head injury with temporary loss of brain function. Symptoms range from physical, cognitive, pain (headache) and emotional signs consistent with TBI and Post-Traumatic Stress Syndrome. Use of AD-cSVF parenteral delivery to encourage repair of damage and decreased function following concussion, particularly in contact, repetitive sports injuries. Range of damage is measured in Grade I-III according to graduated severity. Unfortunately, less information is available about repetitive concussions and the long-term health issues.


Clinical Trial Description

Concussion Syndrome (CS) and TBI are common injuries producing temporary and long-term damage to impact brain function. Symptoms are sometimes transient, sometimes long-term depending on severity and/or repetitive damage. Signs varying from recurrent headaches, mental fog, emotional changes to physical signs of loss of consciousness, amnesia to behavioral change (irritability, loss of concentration ability, etc.), cognitive impairment (slow reaction times, memory loss), and recurring sleep disturbances. Common causes include sports injuries, automobile accidents, falls, blunt trauma to head, and explosive/blast injuries from production of acceleration injuries Treatment often involves monitoring, physical rest, limiting cognitive activities (such as computing, video games, texting, and studying). Most often a single episode usually resolve or improve (particularly in recurring headaches) within 3-4 weeks. It is estimated that >6/1000 occurrence rate apply. Repetitive injuries seem to make the person more susceptible to additional damage, particularly with injury precedes resolution of an earlier damage. There appears also to make persons to require a lesser impact to produce the same degree of severity. It is becoming more recognized that repeated concussions increase the risks in later life for dementia, Parkinson's and severe depressions. Most serious signs to evaluate are loss of consciousness, seizures, worsening headache, diplopia/pupil changes, loss of recognition, vomiting, focal neurological problems, and change of personality. There is no consensus definition of concussion or TBI. Most concussions are considered in the mild TBI (mTBI) group, and are rarely demonstrate structural brain damage when in the acute to subacute state. Late brain MRI changes are difficult to clearly point to or identify the specific areas of presumed damage. This study is intended to examine safety and efficacy of parenteral introduction of AD-cSVF in cases of CS and TBI, and categorically examine the outcomes according to the elapsed time from original concussive event. No delineation of those having recurrent damage and injuries are made within this study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02959294
Study type Interventional
Source Healeon Medical Inc
Contact
Status Withdrawn
Phase Early Phase 1
Start date November 30, 2018
Completion date March 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04109677 - AIM CONTROL and SWECON - Handball The SWEdish CONcussion Study in Elite Handball
Recruiting NCT04932278 - The Role of Osteopathic Manipulative Medicine in Recovery From Concussions N/A
Withdrawn NCT05062148 - Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery N/A
Recruiting NCT05682677 - Combined Neuromodulation and Cognitive Training for Post-mTBI Depression N/A
Recruiting NCT04992130 - Sport Concussion Performance-Based Prevention Program N/A
Completed NCT05095012 - RECOVER Clinical Pathway for Pediatric Concussion N/A
Recruiting NCT05886400 - The Effects of Environmental Distractions on SCAT6 Outcomes N/A
Active, not recruiting NCT05400551 - Craneofacial Injuries in Rink Hockey Athletes
Recruiting NCT04121780 - Growth Hormone Replacement Therapy for Retried Professional Football Players Phase 2
Withdrawn NCT03575741 - Postural Control in Children and Adolescents After Suffering From a Concussion
Active, not recruiting NCT05471791 - Development of a Concussion Management Platform for Children and Youth N/A
Completed NCT04730167 - The Monaco Initiative for Concussion in Motorsport Pilots
Completed NCT03478059 - Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI N/A
Recruiting NCT05685121 - A Wrist-Worn Nerve Stimulator for Remediating Persistent Post-Concussive Symptoms in Adolescents N/A
Completed NCT04122274 - Comparing and Interactive Concussion Education Platform to Current Education Standards N/A
Completed NCT04558346 - Ghrelin (OXE--103) for Acute Concussion Management Phase 2
Completed NCT04074486 - Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
Not yet recruiting NCT05562232 - The Effect of Creatine Monohydrate on Persistent Post-concussive Symptoms N/A
Recruiting NCT05326555 - Dynamic Vision Testing and Concussion Management Dream Team 65
Completed NCT03671083 - Validation of Brain Function Assessment Algorithm for mTBI/Concussion