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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT03691272 Completed - Headache Clinical Trials

rTMS Treatment of Persistent Headache and Post Concussion Symptoms Attributed to Mild Traumatic Injury to the Head

TOPiCS-rTMS
Start date: April 15, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this study is to investigate the treatment effect of repetitive transcranial magnetic stimulation in patients with a history of both persistent post-traumatic headache and post-concussion symptoms. In this double-blind, sham-controlled, concealed allocation, randomized clinical trial, 20 patients aged 18-65 yrs will be recruited from the Calgary Brain Injury Program (CBIP) and the Calgary Headache Assessment and Management Program (CHAMP) / Calgary Chronic Pain Centre, Calgary, Alberta, Canada. Patients will engage in a two-week rTMS treatment protocol (10 treatments) and will be followed for 6 months after therapy.

NCT ID: NCT03688984 Completed - Insomnia Clinical Trials

Treatment of Insomnia for Adolescents With Mild Traumatic Brain Injury

Start date: September 1, 2016
Phase: N/A
Study type: Interventional

A substantial number of children and adolescents sustain a mild traumatic brain injury (mTBI) each year. Although research supports that the vast majority of youth will recover quickly and return to normal functioning, some adolescents continue to report problems long after the injury. Disturbed sleep, notably trouble with sleep onset and sleep maintenance, is a frequently reported problem in those with slow recovery from a mTBI. Poor sleep is also associated with cognitive complaints, mood disturbance, and lower quality of life. Despite the identification of sleep disturbance as a problem associated with slow recovery, there are very few treatment options. Cognitive-behavioural therapy for insomnia (CBT-I) has shown promise in children and adolescents as an effective treatment for sleep disturbance, although it has yet to be applied to the adolescent mTBI population who also present with sleep problems. The objective of this study is to examine the treatment of sleep disturbance using cognitive-behavioural therapy for insomnia (CBT-I) in those adolescents who have a protracted recovery from their mTBI. This represents a novel treatment option for this patient population and is anticipated to improve outcomes and quality of life.

NCT ID: NCT03678077 Completed - Education Clinical Trials

Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury

Start date: September 20, 2018
Phase:
Study type: Observational

Mild traumatic brain injury (mTBI) accounts for 70-90% of all diagnosed traumatic brain injuries (TBI) affecting approximately 50-300 per 100.000 individuals annually. Persistent post-concussion symptoms are reported in 15-80% of hospital admitted and outpatient treated populations, affecting labour market attachment, academic achievement, income, socio-economic status, social interactions, home management, leisure activities and cohabitation status. The association between mTBI and long-term trends in cohabitation status, income, academic achievement and socio-economic status has not been thoroughly explored. Previous studies focus on children's academic performance after severe TBI and only few studies include early adulthood and patients with mTBI. Trends in divorce rates are frequently conducted on severe injuries or populations consisting of veterans. Additionally, all studies have failed to apply a national register based design. Aim The aim of the study is to examine the long-term associations between mTBI and trends in cohabitation status, academic achievement and socio-economic status between pre-injury rates and observed rates at 5 years post-injury. The hypothesis was that by 5 years mTBI would be associated with increased odds of marital breakdown, decreasing academic achievement, decreasing income, decreasing socio-economic status compared to the general population in Denmark. Methods: The study is a national register based cohort study with 5 years follow-up of patients with mild traumatic brain injury from 2008 - 2012 in Denmark. Population: Patients between 18-60 years diagnosed with concussion (ICD-10 S06.0) were extracted from the Danish National Patient Register between (2003-2007). Patients with major neurological injuries and previous concussions at the index date and 5 years before the index date (1998-2007) were excluded. Patients who were not resident in Denmark 5 years before and during the inclusion period were also excluded (1998-2007). Data will be retrieved from several national databases, including: the Danish national patient register, Danish Civil Registration System (CRS), the Danish Education Registers, the Income Statistics Register and the Employment Classification Module (AKM). One control of the general population were matched for each case on sex, age and municipality. Outcome measures are: Cohabitation status, Education, income and socio-economic status.

NCT ID: NCT03677661 Completed - Clinical trials for Mild Traumatic Brain Injury

Cervico-vestibular Rehabilitation for Mild Traumatic Brain Injury

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Neck pain, dizziness and headache are common symptoms following mild traumatic brain injury (mTBI). The efficacy of cervical spine and vestibular-ocular system impairments intervention need to be determined. In this randomized clinical trial, a 6-week personalized clinical rehabilitation program on subacute mTBI will be compare to a conventional approach. The rehabilitation program will include cervical spine exercise combined with manual therapy as well as vestibular-ocular rehabilitation. Overall symptoms will be measured by the Post-Concussion Symptoms Scale (PCSS). Disability and symptoms severity related with neck pain, headache and dizziness will also be evaluated after the treatment period and at 6-week post-treatment.

NCT ID: NCT03674398 Completed - Clinical trials for Acquired Brain Injury

Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to compare a 4-week, moderately intensive, lab and home-based aerobic exercise program versus exercise plus cognitive training. Participants will include individuals who experience lingering symptoms of a head injury or concussion.

NCT ID: NCT03671083 Completed - Clinical trials for Brain Injuries, Traumatic

Validation of Brain Function Assessment Algorithm for mTBI/Concussion

CAS13-25V
Start date: October 1, 2018
Phase:
Study type: Observational

This study is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of validation of the algorithms.

NCT ID: NCT03659006 Recruiting - Clinical trials for Severe Traumatic Brain Injury

Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury

ICON-TBI
Start date: October 15, 2018
Phase: N/A
Study type: Interventional

Tertiary lesions responsible of the neurological decline after severe traumatic brain injury (TBI) are partially due to a persistent neuro-inflammation directly modulated by inflammatory mediators during the acute phase and detectable by using both multimodal MRI imaging and biological biomarkers during the acute phase after traumatic brain injury. The main objective is to identify if the level of IL-1beta in cerebrospinal fluid predict in a reliable and reproducible way, the neuro-radiological evolution evaluated by the comparison of a quantitative MRI performed in post-resuscitation and at one year (quantitative ΔIRM) in traumatic brain injuried patients. The secondary objectives are: - To understand the links between the acute and chronic neuro-inflammatory phase in a population of TBI, - To explore the contribution of the adaptive immune response in the persistent activation of the immune response, - To Examine the links between persistent neuroinflammation, clinical deterioration and neuroimaging, - To establish a correlation between the pathology and the physio-pathology of TBI.

NCT ID: NCT03658135 Terminated - Clinical trials for Nonfluent Aphasia, Progressive

BIIB092 in Primary Tauopathies: CBS, nfvPPA, sMAPT, and TES

TauBasket
Start date: September 12, 2018
Phase: Phase 1
Study type: Interventional

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel Cohort Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Intravenously Infused BIIB092 in Patients with Four Different Primary Tauopathy Syndromes

NCT ID: NCT03655782 Recruiting - Clinical trials for MTBI - Mild Traumatic Brain Injury

Retraining Neural Pathways Improves Cognitive Skills After A Mild Traumatic Brain Injury

Start date: October 27, 2023
Phase: N/A
Study type: Interventional

The proposed study tests the feasibility (Phase I) of PATH neurotraining to improve working memory and attention in mTBI patients rapidly and effectively to provide clinical testing of a therapeutic training for the remediation of cognitive disorders caused by a concussion. This study will contribute to the fundamental knowledge of how to remediate concussions from a mTBI to enhance the health, lengthen the life and reduce the disabilities that result from a mTBI.

NCT ID: NCT03654014 Withdrawn - Clinical trials for Traumatic Brain Injury

NSI Pulsed Electromagnetic Field (PEMF) Biomarker Study

Start date: February 12, 2018
Phase: N/A
Study type: Interventional

Pulsed Electromagnetic Field (PEMF) Reduction of CSF and Serum Biomarkers After Traumatic Brain Injury (TBI). The primary objective of this pilot study is to determine whether PEMF treatment (PEMF+) reduces the magnitude and duration of the increase in CSF and blood biomarkers after traumatic brain injury (TBI) compared to a PEMF untreated (PEMF-) group. Values in both groups are compared to uninjured brain CSF and blood biomarker levels obtained from hydrocephalus patients undergoing ventriculo-peritoneal shunt placement. A secondary objective of this pilot study is to determine whether PEMF treatment improves the physiologic status of the brain as evaluated by brain tissue monitors of thermal dilution cerebral blood flow (CBF), intracranial pressure (ICP), and tissue PO2 (PbtO2). Improved physiologic status would be reflected by increased CBF, PbtO2, and reduced ICP. Improved physiologic status may also be inferred from derived variables reflecting improved cerebrovascular and intracranial pressure autoregulation. A tertiary objective of this pilot study is to obtain preliminary data on the relationship between the time course and magnitude of post-TBI CSF and blood biomarker levels as they relate to three month outcome by Glasgow outcome score extended (GOSE) and modified Rankin Score (mRS).