Clinical Trials Logo

Post-concussion Syndrome clinical trials

View clinical trials related to Post-concussion Syndrome.

Filter by:

NCT ID: NCT01962883 Completed - Clinical trials for Post Concussion Syndrome

Effects of Osteopathic Treatment on Vestibular Disturbed Active Post Concussed Individual

PCS
Start date: August 2013
Phase: N/A
Study type: Interventional

The proposed study is a randomized clinical trial with the purpose of determining the efficacy of osteopathic treatment on vestibular symptoms of the post concussed vestibular disturbed athlete as determined by the Dizziness Handicap Inventory (DHI) and the Balance Error Scoring System (BESS). Of secondary interest, this study will evaluate the osteopathic assessment findings of this population and side effects, positive and negative, associated with the osteopathic treatment provided. Primary Hypothesis 1. Osteopathic treatment will have no effect on the symptoms of dizziness of the vestibular disturbed post concussed athlete using the Dizziness Handicap Inventory 2. Osteopathic treatment will have no effect on the balance recovery of the vestibular disturbed post concussed athlete using Balance Error Scoring System (BESS) Secondary Hypothesis 3. To determine the side effects of osteopathic treatment of the vestibular disturbed post concussed athlete

NCT ID: NCT01874847 Active, not recruiting - Clinical trials for Traumatic Brain Injury

PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin

PLAYGAME
Start date: September 2013
Phase: Phase 2/Phase 3
Study type: Interventional

PURPOSE: The long-term goal of this line of research is to develop rational, biologically based evidence for the treatment of post-concussion syndrome (PCS) in children. The objective of this application is to examine the effect of melatonin on the symptoms of PCS and its neurobiology using integrated neurodiagnostic techniques in children. OVERVIEW: PCS is a constellation of clinical symptoms including physical (i.e. headaches), cognitive (i.e. memory), and behavioral disturbances. PCS is associated with significant morbidity in the child and his/her family), and yet there are no evidence-based medical treatments available. This suggests an urgent need to develop novel treatment options to improve outcomes for children suffering from PCS. Melatonin has several relevant mechanisms of action, and neuroprotective effects. Recent research suggests that the explanations for persistent PCS symptoms may be due to alterations in neurotransmissions and neuronal circuitry, particularly involving the dorsolateral prefrontal cortex (DLPFC). Investigators have two specific aims: 1. To determine if treatment with melatonin improves PCS in children following mild traumatic brain injury. Hypothesis: treatment of mTBI children with PCS with 3mg or 10mg of oral melatonin for 28 days will result in a decrease in PCS symptoms as compared with placebo. Effects will be dose-dependent and may be independent of sleep effects. Methods: A randomized double blind, placebo controlled trial (RCT); Outcome measure is a PCS symptom questionnaire. A subsequent RCT will then be performed using the optimal melatonin dose at a second centre. 2. To understand the neurophysiological mechanisms of paediatric PCS and assess any resultant effects of treatment with melatonin. Methods: A case-controlled study within the RCT, using functional MRI and Transcranial Magnetic Stimulation to investigate the neurophysiological properties of paediatric mTBI before and after treatment; Treatment groups from the RCT will be compared with two control groups: i) normal controls and ii) asymptomatic mTBI children. SIGNIFICANCE: This study has the potential to 1) provide a safe and effective treatment for PCS and 2) will provide valuable information about the neurophysiological properties of the brain associated with PCS following mTBI in children and how these change with symptom resolution.

NCT ID: NCT01789164 Completed - Clinical trials for Traumatic Brain Injury

Measure of Cerebrovascular Dysfunction After TBI With fNIRS

Start date: January 2013
Phase:
Study type: Observational

The goal of this project is to determine if it is possible to assess Cerebrovascular Reactivity (CVR) to hypercapnia with functional Near Infrared Spectroscopy (fNIRS). Such a method would be particularly helpful in traumatic brain injury (TBI), where objective measures are needed, and would greatly expand the capacity to make such assessments in standard clinical practice.

NCT ID: NCT01762475 Completed - Clinical trials for Traumatic Brain Injury

Sildenafil for Cerebrovascular Dysfunction in Chronic Traumatic Brain Injury.

Start date: January 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether sildenafil (Viagra®) is effective in improving cerebral blood flow and cerebrovascular reactivity inpatients who have persistent symptoms at least 6 months after a traumatic brain injury (TBI).

NCT ID: NCT01747811 Completed - Concussion, Mild Clinical Trials

Effects of Bright Light Therapy in Mild Traumatic Brain Injury

Start date: December 2010
Phase: N/A
Study type: Interventional

Mild traumatic brain injuries (mTBI) or "concussions" are an increasingly prevalent injury in our society. Patients with post-concussion syndrome have been shown to have deficits on tests of short term memory, divided attention, multi-tasking, information processing speed, and reaction time, as well as alteration in mood and emotional functioning. Many patients have other vague complaints including fatigue, dizziness, irritability, sleep disturbances, and chronic headaches. Furthermore, sleep disruption of one of the most common complaints in patients suffering from traumatic brain injuries, with as many as 40 to 65% of patients with mTBI complaining of insomnia. Sleep problems in these patients are associated with poorer outcome, while resolution of the sleep disturbance is associated with improvement in cognitive functioning. Despite recent evidence of the correlation between sleep quality and recovery from traumatic brain injury, and the well-established role of sleep in neural plasticity and neurogenesis, there have been virtually no direct studies of the causal effects of sleep on recovery following mTBI. However, it is quite likely that sleep plays a critical role in recovery following brain injury. A particularly promising non-pharmacologic approach that shows potential in improving/modifying abnormalities of the circadian rhythm and sleep-wake schedule is bright light therapy. For the proposed investigation, we hypothesize that bright light therapy may be helpful in improving the sleep of patients with a recent history of mTBI and may also have other mood elevating effects, both of which should promote positive treatment outcome in these individuals. Bright light therapy may increase the likelihood that they will recover more quickly, benefit more extensively from other forms of therapy, and build emotional and cognitive resilience.

NCT ID: NCT01611194 Completed - Clinical trials for Post-Concussion Syndrome

mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms

BIMA
Start date: September 11, 2012
Phase: Phase 2
Study type: Interventional

Purpose of this study is to investigate the mechanisms of action of hyperbaric oxygen therapy for persistent post-concussive symptoms after mild tramatic brain injury

NCT ID: NCT01502839 Terminated - Clinical trials for Traumatic Brain Injury

Role of NSI in Differentiating Between Mild Traumatic Brain Injury And Behavioral Health Conditions

Start date: March 2011
Phase: N/A
Study type: Observational

The purpose of this study is to examine differences in post-concussive (PC) symptom endorsement among four groups of Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans: those with a history of target, service-related, mild traumatic brain injury (mTBI) and co-occurring posttraumatic stress disorder (PTSD) (Group 1); those with a history of target, service-related, mTBI only (Group 2); those with PTSD only (Group 3); and those with no history of target, service-related, mTBI or PTSD (Group 4) by examining scores on the Neurobehavioral Symptom Inventory (NSI). Support for this study is provided by previous research highlighting the complex relationship between mTBI, PTSD and subsequent PC symptom endorsement (Brenner et al. 2010; Terrio et al, 2009). HYPOTHESES ARE AS FOLLOWS: 1. Individuals with a history of target, service-related, mTBI only (Group 2) and individuals with PTSD only (Group 3) each will report significantly more PC symptoms, as measured by NSI total scores, when compared to those with no history of service-related mTBI or PTSD (Group 4). 2. Individuals with co-occurring target, service-related, mTBI history and PTSD (Group 1) will report significantly more PC symptoms, as measured by total NSI scores, than either those with target, service-related, mTBI only (Group 2) or those with PTSD only (Group 3).

NCT ID: NCT01334528 Completed - Clinical trials for Mild Traumatic Brain Injury

Consistency of Automated Neuropsychological Assessment Metrics (ANAM) Performance in Those With Deployment Acquired Mild Traumatic Brain Injury (TBI)

ANAM
Start date: February 2011
Phase: N/A
Study type: Observational

The purpose of this project is to explore the degree to which performance consistency on neuropsychological measures varies in a sample of Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with persistent self-reported symptoms.

NCT ID: NCT01315379 Recruiting - Clinical trials for Traumatic Brain Injury

Psychological Treatment for Children Suffering From Post Traumatic Stress Symptoms and Mild Traumatic Brain Injury

TBI
Start date: April 2011
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether Prolonged Exposure Therapy (PE)is effective in the treatment of post-traumatic stress symptoms in children and adolescents with mild traumatic brain injury (m-TBI) due to motor vehicle accident.

NCT ID: NCT01306968 Completed - Clinical trials for Traumatic Brain Injury

Hyperbaric Oxygen Therapy (HBO2) for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (mTBI)

HOPPS
Start date: February 2011
Phase: Phase 2
Study type: Interventional

This is a Phase II randomized trial designed to describe the magnitude of change between baseline and follow-up outcomes for symptom surveys and a battery of neuropsychological tests administered at time points corresponding before and after 10 weeks over observation in four groups: - A military population with post-concussion syndrome (mTBI) receiving local standard care - A military population with post-concussion syndrome (mTBI) receiving local standard care and sham hyperbaric oxygen sessions - A military population with post-concussion syndrome (mTBI) receiving local standard care and hyperbaric oxygen at 1.5 atmospheres sessions - A otherwise similar group with PTSD but no history of TBI receiving local standard care Differences and variability of the tests will be used for determining the optimum primary endpoint(s) for future trial, as well as for refinement of sample size and power calculations for these studies. The groups undergoing hyperbaric sessions will be assigned to receive HBO2 or sham using a randomized, double blind design. Active duty military (Army, Marine, Navy, Air Force) men and non-pregnant women residing in the United States and who will remain in the military for the entire study period, aged 18-65 years who have been deployed one or more times to the US Central Command since the initiation of Operation Enduring Freedom (October 7, 2001) who either: - have been diagnosed with Post Traumatic Stress Disorder (PTSD) as a result of traumatic events that occurred during the qualifying CENTCOM deployment, but have no diagnosed or suspected lifetime brain injuries resulting in loss or alteration of consciousness; OR - have been diagnosed with at least one mild brain injury (mTBI) with persistent (> 4 months) symptoms sustained during one or more of those deployments