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Statement & Public Disclosure of Clinical Research

Association Between Cold Weather and Concussions Mr. Bobby L Porter, Behavioral Health & Clinical Psychology

Through my research at the beginning I was unable to find any data backing up my hypothesis on any Association between Cold Weather and Concussions, and in talking with my wife’s doctors, Dr. Sandy S Mcgaffigan MD, Neurologist at Northwest Neurology, Dr. Mahendra R. Shah Psychiatrist at Metro Behavioral Care LLC and Dr.  Rush David Ph.D. Psychologist at Anxiety & Psychological Center of Riverdale, Georgia. Therefore, I took my concerns to my colleagues in the Department of Psychology at the South University of Georgia. At this point, no one’s aware of any association between cold weather and concussions. There is not a wealth of literature to support the idea that Cold Weather and Concussions have an Association to back up my hypothesis. Continued research and development are needed in my journey to find a name for this acute problem.

Intention of Research

My research is intended to explore and develop data backing up my hypothesis on the Association between Cold Weather and Concussions. We know that Concussion symptoms do not simply resolve, and there is the possibility of additional symptoms developing over time. How Concussive brain trauma: neurobehavioral impairment and maladaptation, could be affected by environmental factors like temperature (Cold Weather) after a concussive event? How both Cold Weather, biological, behavioral, and environmental factors are influencing my wife’s severe headaches, increasing sensitivity to sounds and light, also increasing her hypertension. How Cold Weather and Concussions is promoting damage to the individual’s immune system, lowered nutrition/intake, explicit or declarative memory loss, psychometric measures of cognition, thinking, memory, information processing, and one’s intelligence / (IQ). I will also look at how the Association between Cold Weather and Concussions is promoting difficulties through the post-trauma functioning level of the individual in the area of severe depression, ranging from the pole of extreme highs and lows throughout the day that will linger for several hours. I will look at various neurophysiological and neurochemical by-products of the trauma such as the neurochemical effects of stress, which can create the symptoms that an individual experiences on a day to day basis after a Concussion and or brain trauma related to cold weather. Develop data to assist Neuropsychology and rehabilitation measures that more fully assess emotional functioning, anxiety states, hyperarousal, vigilance, circulatory effects, systemic effects, and multiple system involvements as regulated by the brain as cold Weather and Concussions is promoting difficulties. Last, I will look at the Association between cold weather and speech impairments such as slow or slurred speech that is more severe as body temperatures continue to fall due to environmental factors like (e.g., Cold Weather, quick temperature dropping fast/slow, cold water during a shower ect.).

Key Questions

  1. Concussions and Cold Weather: Do plunging temperatures make people with Head Injuries More Likely to experience a higher range of sensory processing problems, strong tendency to see things that are not there, have severe headaches, increasing sensitivity to sounds and light, and increasing physiological hypertension of the sympathetic nervous system?
  2. Can environmental factors like temperature affect a person with a head injury longterm?
  3. Is this a syndrome, effects from the head injury, or an unexplained symptom linked to the Concussions itself, longterm post three years after the accident?
  4. Could Vitamin B-12 deficiency be associated with Cold Weather and Concussions by increasing sensitivity? Note: Vitamin B-12 deficiency is proven to be related to TBI-Traumatic Brain Injury patients, and Language and Speech impairments.
  5. Could Vitamin D and Cold Weather play an important role influencing T-regulatory (Th3) cells in Post-Concussion patients, which govern the expression and differentiation of Th1 and Th2 cells?
  6. How Concussive brain trauma: neurobehavioral impairment and maladaptation, could be affected by environmental factors like temperature (Cold Weather)?
  7. Was my wife one of the Individuals with brain injury’s (particularly those with minor/mild brain injury) could she have been misdiagnosed or neglected post two months from the date of the brain injury before the first MRI was completed.

Physiological changes from cold weather

In my research, through observation and verbal conversations with my wife I have determined she is suffering from repetition associated with cold weather and her concussion. She will have dizziness, light sensitivity, smell sensitivity, nausea, the pressure in head, and pressure in the eye. Also suffering from twitching when sleeping, severe headaches, increase hypertension, impaired judgment, and anxiety with panic attacks. During the cold weather, the pain in the head is more severe on the left side of her frontal lobe, the part of the brain that controls important cognitive skills, also the exact side of the head injuries. All of this is brought on post environmental factors like Cold Weather.

Value of research

To find a successful treatment of concussive brain trauma and its effects on environmental factors like temperature and how it affects a person with a head injury longterm. We must also consider the individual’s level of emotional adjustment, by identifying the possible health consequences of persistent stress reactions such as damage to the individual’s immune system, lowered nutrition, explicit or declarative memory loss, psychometric measures of cognition, thinking, memory, information processing, and intelligence. We must look at the “Determination of ‘recovery’ or its degree, must also consider higher-level functions, social interactions, recreation, emotional behavior, and role activities (work, school, environmental factors, and home management).” Treatment must include assisting the individual with adjustment to the current “sense of self,” understanding the dynamic impacts of change, assisting the person with the ability to adapt and adjust, and addressing problems with self-awareness.

Contributing factors include

Contributing factors include, but are not limited to, gathering information about preexisting factors, previous head trauma, ecological demands, developmental age, community support, emotional factors, social interests, the stress of litigation, motivation, and the individual’s will to survive. Neuropsychology and assessment of those that have sustained brain injury have to transcend psychometric measures of cognition, thinking, memory, information processing, and intelligence.

Background Data

Tammy is spending most of her time having difficulties in the area of visual sensory processing, severe depression, ranging from the pole of extreme highs and lows throughout the day that will linger for several hours. She has difficulties in communicating how she is feeling, at the same time juggling her responses. She seems to understand a conversation that is going on at the time, but if you have her to repeat it back to you, she is unable to remember any or all of the conversation. Tammy is experiencing some severe mood swings, giving answers to questions not related to the original questions.

  1. Disabilities and Medical Conditions: She had a TBI-Traumatic Brain Injury, active Language and Speech impairments, experiences difficulty saying words correctly in a consistent way, short-term and long-term memory loss, problems and impaired judgment, and anxiety with panic attacks. She is very sensitive to fluorescent lighting. Post-concussion syndrome, severe headaches, increased sensitivity to sounds, and hypertension high blood pressure. All of this has changed Tammy’s life from the Headaches, Memory loss, Difficulty multi-tasking, Anxiety, Irritability, difficulty overcoming changes in weather conditions and Fatigue, that should have been resolve within 6-11 months after an injury happened.
  2. Cognitive and Communication Problems: She has Difficulty keeping up with a conversation, poor organizational problems, and impaired judgment. Unable to do more than one thing at a time, she has speech impairment when articulating her words. Tammy cannot follow written instructions without getting nervous and have some attack. The symptoms of her chronic Depression have affected her performance from the bedroom to everyday life in our marriage. She has problems concentrating for periods of time, having trouble organizing thoughts, and becoming easily confused or forgetful. Almost every day Tammy will experience difficulty learning new information; unable to interpret the actions of others. Therefore, she has greater problems in any social situation.
  3. Visual sensory processing: Tammy frequently seems bothered by light, especially bright lighting, becomes distressed in unusual visual environments. Difficulties in the area of body awareness and Difficulties in the area of balance and motion are seen through observation. She seems to have fewer difficulties with incandescent lighting but increased difficulties with fluorescent lighting, therefore experiencing some severe mood swings and severe headaches until she leaves the room.
  4. Difficulties in the area of planning: Tammy is showing evidenced by observation only that she frequently performs inconsistently in daily tasks, has trouble figuring out how to do multiple things at the same time, seems confused about how to, perform tasks in proper sequence, and fails to complete tasks with multiple steps.
  5. Post-traumatic responses: She has experienced physical and emotional trauma which is associated with very high rates of posttraumatic responses. Tammy has flashbacks and dissociation that are often triggered more than ones but not less than 5 or 6 times a week. She has severe signs of PTSD with emotional distress or physical reactions to what has happened to her after the accident from work. As the PTSD is triggered, Tammy is getting mad about what has happened to her at work. She also can’t understand why it happens to her. The flashbacks and dissociation are triggering panic attacks daily. She is experiencing fatigue, but decrees in need of sleep. Through the day she is having speech impairments such as slow or slurred speech.
  6. Panic attacks: She is showing evidenced by observation, experiencing trouble getting words out quickly before or during a panic attack. Tammy’s panic attacks have gotten worse and harder to overcome just about every day. She will struggle to pull herself out of the anxiety disorder after it starts, she will get little to no relief from the panic attack even with medication.
  7. Hallucinations: Tammy has a strong tendency to see things that are not there, example, people, cars, flashes of light that do not exist to anyone but her. This makes her feel like she is going crazy and then it will throw her in a severe panic attack. She has the Hallucinations most of the time with different types of Paranoia; Tammy has Delusions even when I am driving, example cars or people on the side of the road that is not there. A different Example would be she had a Hallucination of a nude Chinese man setting in a trashcan, in return was not true.

WHO Statement on Public Disclosure of Clinical Trial

Reiteration of WHO position on clinical trial registry sites

Before any clinical trial is initiated (at any Phase), its details are to be registered in a publicly available, free to access, searchable clinical trial registry complying with WHO’s international agreed standards. The clinical trial registry entry should be made before the first subject receives the first medical intervention in the trial.

Public Disclosure of randomized experimental studies

  1. http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
  2. A clinical trial is defined as an experimental study which prospectively allocates humans to medical intervention. While randomized assignments are considered of highest value for assessing the safety and efficacy of an intervention, the WHO definition of a clinical trial for reporting purposes also includes non-randomized assignments, for example in Phase I trials. As safety problems may occur in (Phase I trials), it is critical that the same disclosure mechanisms apply for non-randomized (Phase I trials) as apply to randomized (Phase I, II trials) or (III trials). Phase IV or post-licensure trials of health products are considered clinical trials if they involve prospective designs (with or without randomization). Clinical trials have pre-specified research or product development objectives, and so routine use of health interventions without specified research objectives are not considered to be within the definition of a clinical trial.

Updating clinical trial registry entries

All clinical trial registry sites are to be updated as necessary to include final enrolment numbers achieved, and the date of actual study completion (defined as the last data collection time point for the last subject for the primary outcome measure). If clinical trials are terminated, their status is to be updated to note the termination, and to report the numbers enrolled up to the point of termination.

Inclusion of Trial ID in clinical trial publication

The Trial ID or registry identifier code/number is always to be included in all publications of clinical trials and should be provided as part of the abstract to PubMed and other bibliographic search databases for easy linking of trial reports with clinical trial registry site records. Bibliographic search.

Reporting timeframes for clinical trials

All Clinical trial results are to be reported according to the timeframes outlined below. Reporting is to occur in BOTH of the following two modalities.

  1. The main findings of clinical trials 3 are to be submitted for publication in a peer-reviewed journal within 12 months of study completion and are to be published through an open access mechanism unless there is a specific reason why open access cannot be used, or otherwise made available publicly at most within 24 months of study completion.
  2. Also, the key outcomes 4 are to be made publicly available within 12 months of study completion by posting to the results section of the primary clinical trial registry. Where a registry is used without a results database available, the results should be posted on a free-to-access, publicly available, the searchable institutional website of the Regulatory Sponsor, Funder or Principal Investigator.

Data Sharing Initiatives

All The benefit of sharing research data and the facilitation of research through greater access to primary datasets is a principle which WHO sees as important. This statement is not directed towards sharing of primary data. However WHO is actively engaged with multiple initiatives related to data sharing, and supports sharing of health research datasets whenever appropriate. WHO will continue to engage with partners in support of an enabling environment to allow data sharing to maximize the value of health research data.

Sponsors needed for early planning process and research

I am looking for professionals in the forensic arena, Professionals involved in conducting independent medical examinations (IME), Neurologist, cold weather Neurologist, Psychiatrist, and Psychologist at an Anxiety & Psychological Center.

Sponsorship is required for studies under the Research Governance Framework(s) including trials that that fall within the scope of the Clinical Trial Regulations. I need to secure a sponsor(s), so I am trying to identify a sponsor(s) to be considered early in the planning process.

Please contact me through the contact information below.

 

Thank You,

Mr. Bobby Porter, NSCS
South University of Georgia                                       
College of Arts & Sciences                                         
Behavioral Health & Clinical Psychology                  
Phone: 678-353-8599 Fax: 678-399-3936
Bobbyporter1@stu.southuniversity.edu

Institutional Accreditation

South University is accredited by the Southern Association of Colleges and Schools Commission on Colleges to award associate, bachelors, masters, and doctorate degrees. Contact the Commission on Colleges at 1866 Southern Lane, Decatur, Georgia 30033-4097 or call 404.679.4500 for questions about the Specialized, Professional, or Programmatic Accreditation of South University.

Reference

Havranek, J. E. (2003). Concussive brain trauma: Neurobehavioral impairment and maladaptation. Journal of Applied Rehabilitation Counseling, 34(4), 45-46. Retrieved from http://search.proquest.com/docview/216481193?accountid=87314

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