Auditory gamma sensory stimulation for Brain Injuries

Phase-Based Estimates
1
Effectiveness
1
Safety
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, MA
Brain Injuries+1 More
Auditory gamma sensory stimulation - Other
Eligibility
18+
All Sexes
Eligible conditions
Brain Injuries

Study Summary

This study is evaluating whether a new approach to detect and remediate the effects of blast exposure on veterans may be effective.

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Eligible Conditions

  • Brain Injuries
  • mTBI

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Auditory gamma sensory stimulation will improve 2 primary outcomes in patients with Brain Injuries. Measurement will happen over the course of 20 minutes.

20 minutes
Change in evoked gamma power of conditioned vs. unconditioned tones
Change in spontaneous gamma power

Trial Safety

Trial Design

2 Treatment Groups

Control
All participants

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Auditory Gamma Sensory Stimulation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

All participants
Other
All participants receive auditory gamma sensory stimulation.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 20 minutes
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 20 minutes for reporting.

Closest Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Recruited from the VA Translational Research Center for TBI and Stress Disorders (TRACTS) at the VA Boston Healthcare System (VABHS)
Half of the participants will have experienced blast exposure from a Close distance (<10 m)
Research participants will be 50 veterans
Ages 18-65 years
Have experienced blast exposure
Half of the participants will have experienced blast exposure from a Far distance (>10 m)
These groups will be matched on age and female/male ratio

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get brain injuries a year in the United States?

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Brain injuries cause nearly 1.8 million injuries per year, which is 4.5% of total injuries suffered annually. There are many different types of brain injuries, although the vast majority of these are categorized as minor injuries. There is no correlation between incidence of brain injury and gender, and an increased incidence of brain injury was present in persons who reported they had a lower income in the past week. No correlation was found between brain injury and age.

Unverified Answer

What are common treatments for brain injuries?

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This review is useful for treatment specialists when thinking about the treatment of brain injuries. Given the large variation in injuries to the brain, it gives a starting point for treatment planning. A comprehensive clinical picture is required. An ongoing care plan is essential to ensure an uninterrupted and safe rehabilitation trajectory. This review provides an indication of future treatment plans based upon current and future advances in the neurosciences, neuroimaging, and neuroscience.

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What causes brain injuries?

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There are many causes, ranging from external causes such as car crashes or violence-related trauma, to neurodegenerative conditions such as Alzheimer's. Brain injuries can have more than one contributing factor, so prevention efforts should target the causes with an emphasis on minimizing risk factor modification.

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What is brain injuries?

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Traumatic brain injury (TBI) has negative impacts that include loss of physical function and mental health. The impact of TBI can occur in a variety of ways and may result in long term physical and/or mental disabilities. The physical manifestations observed from brain injuries are a result of acute injury and also have a long-term impact on individuals functionality. Injuries can occur in a variety of ways including falling, blunt or penetrating trauma, motor vehicle accidents, concussions and head injuries.

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Can brain injuries be cured?

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Overall results suggest that the development of strategies for treating brain injuries is needed at multiple levels: (1) development of neuroprotective agents; (2) enhancing neuroregeneration through transplantation approaches; (3) development of specific diagnostic and surgical tools; (4) development of improved therapeutic and rehabilitation strategies.

Unverified Answer

What are the signs of brain injuries?

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The absence of physical signs of brain injuries may lead to delays in timely brain injuries presentation to a healthcare provider. Physicians need to be aware and remember the subtle, yet clinically significant, signs of brain injuries. Those who manage patients with brain injuries and are asked to consult the neurology service with unexplained headache and/or focal neurological symptoms should remember to consider an organic cerebral lesion/pathological process whenever the symptoms persist beyond a period of 2–45 days.

Unverified Answer

How serious can brain injuries be?

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A survey of 10 U.S. states determined that 1 in 20 reported being hit by a person in 1997 who had a car accident that caused a severe brain injury. The survey's results were consistent with previous surveys that showed that 1 in 2 reported being hit by a person who had a car accident that caused a serious injury to the brain.

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Have there been any new discoveries for treating brain injuries?

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For those who are already brain injured and have shown improvement from a coma, a few treatments have shown significant gains: in addition to conventional treatments, electrical stimulation of the cortex and the substantia nigra, administration of high doses of dexmedetomidine and magnesium oxide, and administration of anesthetic medications can help improve the outcomes of those with brain injuries.

Unverified Answer

Who should consider clinical trials for brain injuries?

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Clinical trials can help patients with brain injuries improve their cognitive and functional abilities. Clinical trials typically require a small number of participants. Given limited sample size, a lower rejection rate is expected. For that reason, clinicians should consider clinical trials if 1) brain injury can be caused by a known external causable factor, 2) there is evidence that a specific intervention (treatment) affects outcome, and 3) the risks from a trial are lower than the risks of not trials.

Unverified Answer

Has auditory gamma sensory stimulation proven to be more effective than a placebo?

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The effectiveness of the auditory gamma sensory stimulation has been confirmed. The combination of auditory gamma sensory stimulation and cognitive training may be useful for the rehabilitation of patients with CVS.

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Is auditory gamma sensory stimulation typically used in combination with any other treatments?

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There is no evidence-based rationale for auditory gamma sensory stimulation as a treatment for brain injury. In particular, no strong benefits were found for outcomes for which auditory gamma stimulation has been proposed as a treatment.

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What are the common side effects of auditory gamma sensory stimulation?

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The current findings suggest that auditory gamma sensory stimulation is safe for human use. The most frequently reported side effects are: nocturia, sleep disturbances, dry mouth and dizziness.

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