Observational Study of Cortical Spreading Depression in Human Brain Trauma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Since the primary damage from traumatic brain injury (TBI) is irreversible, the focus of medical management of TBI is preventing secondary injury that can be life-threatening and worsen patient outcome. Insight into the pathologic mechanisms of secondary injury, which are largely unknown, is required for developing better treatments.

In preliminary studies, the investigators have found that a pathologic brain activity, known as spreading depression, recurs in a large number of TBI patients in the first week after injury. Spreading depressions are short-circuits of brain function that arise spontaneously from an injury and spread repeatedly as waves into neighboring brain tissue. Animal research has shown that spreading depressions can cause secondary injury to the brain.

The primary objective of this observational study is to determine whether the occurrence or severity of spreading depression is related to worse neurologic recovery from TBI. Results from the study will determine whether monitoring of spreading depression should be used as a guide or target for improved medical management of the TBI patient.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intravenous Ketamine Plus Neurocognitive Training for Depression

NCT03237286

Depression

COMPLETED PHASE1/PHASE2

Cognitive Fitness for Depression in Older Adults

NCT04790630

Depression Mild Depressive Disorder, Major Mild Cognitive Impairment

COMPLETED NA

The Relations Among Endotoxin, Inflammatory Cytokines, Cognitive Markers and Brain MRI Changes in Subjects With Depressive Disorder

NCT06203015

Major Depressive Disorder Inflammation Cognitive Dysfunction +3 more

RECRUITING

Altering Default Mode Network Activity With Transcranial Focused Ultrasound to Reduce Depressive Symptoms

NCT06320028

Depressive Disorder, Major Depression

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Non-invasive BCI and Application Verification for Depressed People

NCT06417437

Depression Major Depressive Disorder Bipolar Depression

RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18-80 years old
* diagnosis of TBI
* craniotomy performed as per required treatment of TBI
* craniotomy surgery \< 7 days after TBI
* GCS\<13 at time of decision for surgery
* expected neuromonitoring for \>72 hr