Cognition Disorder Clinical Trial
Official title:
Detection of Hemodynamic Changes in Traumatic Brain Injuries Population With Functional Near Infrared Spectroscopy
Verified date | July 1, 2013 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- The amount of blood flowing in brain areas goes up when those areas are being used for
activities, such as movement or seeing. Functional magnetic resonance imaging (fMRI) is a
common way of measuring blood flow in the brain. Near infrared spectroscopy (NIRS) can also
be used to study blood flow in the brain. However, NIRS has not been used as often as fMRI.
Researchers want to compare fMRI and NIRS to see whether they give similar results. These
studies will be used to look at people who have had a traumatic brain injury.
Objectives:
- To test how well NIRS measure changes in blood flow in the brain after a traumatic brain
injury.
Eligibility:
- Individuals between 18 and 60 years of age who have had a traumatic brain injury.
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a physical exam and medical history. Researchers may
ask to see brain images during from previous MRI scans.
- Participants will have a NIRS scan of the brain. They will be asked to do certain tasks
while inside the scanner. These tasks will involve responding to images that appear on a
screen.
- Treatment will not be provided as part of this study.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 1, 2013 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
- INCLUSION CRITERIA: Healthy population - Age 18 to 60, inclusive. Traumatic brain injuries population - Age 18 to 60. - Have a recorded past traumatic brain injuries rated in the Glasgow Coma Scale between 9 and 15 EXCLUSION CRITERIA: - Pregnancy - History of hypertension - History of any disease of the central nervous system - Current use of sedating medication, including antihistamines - Subjects with any of the following will be excluded from MRI testing: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator; cochlear implant; ocular foreign body, such as metal shavings; permanent eyeliner; insulin pump; or irremovable body piercing due to the possible dangerous effects of the MRI magnet upon metal objects in the body. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Hanna-Pladdy B. Dysexecutive syndromes in neurologic disease. J Neurol Phys Ther. 2007 Sep;31(3):119-27. Review. — View Citation
Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41. doi: 10.1016/S1474-4422(08)70164-9. Review. — View Citation
Strangman GE, Goldstein R, O'Neil-Pirozzi TM, Kelkar K, Supelana C, Burke D, Katz DI, Rauch SL, Savage CR, Glenn MB. Neurophysiological alterations during strategy-based verbal learning in traumatic brain injury. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):226-36. doi: 10.1177/1545968308324225. Epub 2008 Dec 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The main outcome measures will be to identify if the brain flow hemodynamic between the healthy and the TBI group is affected by trauma. | |||
Secondary | The secondary outcome of the two parametric paradigms will investigate if the degree of disruption correlates with measures of the severity of injury (GC scale). Finally, we will compare individual measurement form TBI patient with the health... |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05077501 -
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ACD856
|
Phase 1 | |
Recruiting |
NCT04562844 -
Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury
|
N/A | |
Not yet recruiting |
NCT05490628 -
The Effects of Cognitive Rehabilitation on Motor Performance, Balance and Fear of Falling in Stroke Patients
|
N/A | |
Active, not recruiting |
NCT05111275 -
Cognitive Exercises in Survivors of a Prolonged ICU Stay.
|
N/A | |
Recruiting |
NCT05201534 -
Interventions in Mathematics and Cognitive Skills
|
N/A | |
Recruiting |
NCT05464472 -
Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions
|
||
Not yet recruiting |
NCT06357195 -
DIAMOND-Lewy Guidelines for Antipsychotic Use in Older Patients
|
||
Recruiting |
NCT05886114 -
A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China
|
N/A | |
Withdrawn |
NCT04019665 -
Self-screening of Cognitive Impairment in Primary Care
|
N/A | |
Completed |
NCT00240695 -
A Follow-up Study to Assess Safety and Tolerability of Galantamine Treatment in Individuals With Mild Cognitive Impairment
|
Phase 3 | |
Completed |
NCT04219774 -
NeuroCognition After Carotid Recanalization
|
Phase 2 | |
Not yet recruiting |
NCT06268080 -
Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery
|
N/A | |
Completed |
NCT00695136 -
The Effect of Donepezil (Aricept(Registered Trademark)) on REM Sleep in Children With Autism
|
Phase 1/Phase 2 | |
Recruiting |
NCT04911738 -
VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical
|
N/A | |
Completed |
NCT05783830 -
Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856
|
Early Phase 1 | |
Recruiting |
NCT06186102 -
Polyamine Treatment in Elderly Patients With Coronary Artery Disease
|
Phase 2 | |
Recruiting |
NCT05322031 -
The Impact of Aripiprazole Long-acting on Myelin and Cognition in the Onset of Schizophrenia
|
Phase 4 | |
Completed |
NCT04210713 -
Neuroimmune Dysfunction in Alcohol Use Disorder
|
Phase 1 | |
Completed |
NCT05077631 -
Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics
|
Phase 1 | |
Enrolling by invitation |
NCT06314464 -
Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI
|
N/A |