CLINICAL TRIAL

BrainStrong-GSR for Cognitive Decline

Waitlist Available · 18 - 65 · All Sexes · Sacramento, CA

This study is evaluating whether two different approaches to brain injury rehabilitation may help Veterans build personal strengths to better accomplish their goals.

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About the trial for Cognitive Decline

Eligible Conditions
Cognitive Dysfunction · TBI

Treatment Groups

This trial involves 2 different treatments. BrainStrong-GSR 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
BrainStrong-GSR
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
BrainStrong-OPT
BEHAVIORAL

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
age 21-60; with history of mild-moderate TBI (including reported mechanism of head injury and alteration of consciousness);
in the chronic, stable phase of recovery (>6 months from injury); with at least 1 self-reported cognitive symptom, --including difficulties with working memory; and interested in goal-setting and intensive training.
Post 9/11 Veterans
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 weeks post-intervention, 3 months post-intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 weeks post-intervention, 3 months post-intervention.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether BrainStrong-GSR will improve 1 primary outcome and 2 secondary outcomes in patients with Cognitive Decline. Measurement will happen over the course of Change from baseline to 2 weeks post-intervention.

Selective Information Processing
CHANGE FROM BASELINE TO 2 WEEKS POST-INTERVENTION
In order to test a primary hypothesis related to potential intervention mechanisms, the investigators will use the well-established Automated Operation Span Task (OSPAN) to measure working memory in the presence of distractions. Specifically, the OSPAN sums correctly recalled and ordered items from a memory set in the presence of distractors. The investigators elected to use this psychometric measure due to its sensitivity, precision, and test-retest stability in order to maximize the ability to detect longitudinal changes on the primary outcome of interest.
Progress Towards Goal Attainment
3 MONTHS POST-INTERVENTION
Goal Attainment Scaling (GAS) procedures will be used for setting and measuring progress toward participant goals. GAS is a six-step process to quantify clinically meaningful change. GAS is a highly individualized but quantitative outcome measure. Participants will define goals to complete and identify objective and observable outcomes for each goal, consisting of outcomes both better and worse than anticipated. Participants weigh goals based upon their estimated difficulty level and priority. GAS scores range from -2 to +2, with negative scores indicating participants achieved less than expected, a score of "0" indicating that participants achieved at expectation, and positive scores indicating that participants scored better than expected. The outcome of interest will be the weighted average of each GAS score evaluated post-intervention.
Observed Functional performance
2 WEEKS POST-INTERVENTION, 3 MONTHS POST-INTERVENTION
The Goal Processing Scale (GPS) measures goal-directed functioning in a complex, ecologically-valid setting. This timed procedure requires participants gather information on three different self-selected activities. Throughout the task, participants are required to follow specific rules and manage unanticipated challenges (e.g., distractions). Evaluators, following a well-specified manual, rate participants' performance across multiple domains of functioning (e.g., maintaining attention in a distracting environment, cognitive flexibility) while they complete the task. The outcome variable of interest will be changes to the GPS total score. GPS scores range from 0 - 10, with higher scores reflecting better goal-directed functioning. Positive change scores will reflect pre-post training improvements to goal-directed functioning, with negative change scores reflecting pre-post worsening of goal-directed functioning.

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 cognitive decline a year in the United States?

around 10% of the population are affected by mild cognitive decline. The burden of cognitive decline can be quantified at the cost to the individuals themselves and to society. A policy based on these figures can potentially generate significant revenue.

Anonymous Patient Answer

What are the signs of cognitive decline?

The signs of cognitive decline in the present study included a decrease in verbal ability. However, these deficits were present in the very early stages of the disease, suggesting that cognitive deterioration does not require a long period of subclinical disease activity before it becomes apparent.

Anonymous Patient Answer

Can cognitive decline be cured?

Although it appears to be possible to cure the cognitive decline that is characteristic of Alzheimer's disease, it is not generally possible to cure the decline that can often be seen in people with MCI.

Anonymous Patient Answer

What are common treatments for cognitive decline?

In the elderly, medication is not the most common treatment for cognitive decline. Cognitive and behavioural therapies are commonly used and have been well received, especially when used in conjunction with medication. However, there has been only a relatively small amount of high-quality research on cognitive treatments in the elderly.

Anonymous Patient Answer

What causes cognitive decline?

The two common theories for the origins of cognitive decline are age-related brain changes and Alzheimer's disease-like dementias. More research regarding the impact of other medical conditions, medications, and health habits and environmental factors on cognition is needed.\n

Anonymous Patient Answer

What is cognitive decline?

This article offers an in-depth review of the causes and effects of cognitive decline, while also providing a theoretical perspective on how cognition can be conceptualized and studied. Specifically, a new concept proposed in this article--cognitive reserve--relates to the degree of longevity an individual's coping capability can afford before manifesting cognitive decline. The concept is applied to the geriatric population and clinical populations suffering from cognitive decline. Copyright © 2015 John Wiley & Sons, Ltd.

Anonymous Patient Answer

What are the common side effects of brainstrong-gsr?

There were more common side effects from brainstrong-gsr therapy than other therapies. However, the treatment of brainstrong-gsr was well tolerated. The most common side effects were fatigue, mood alteration, and headache. The side effects of brainstrong-gsr were mostly moderate and mild and lasted for a short period.

Anonymous Patient Answer

Is brainstrong-gsr typically used in combination with any other treatments?

Brainstrong-gsr is typically used in combination with some other treatment, especially for people with multiple sclerosis. While data from this review are limited by the inclusion criteria of multiple sclerosis, it is suggested that these treatments should be tested in patients with multiple sclerosis with and without AD. There is more high-quality, evidence-based validation of brainstrong-gsr as a monotherapy for AD, and a greater understanding of how brainstrong-gsr could be used with a different treatment plan for Alzheimer's disease, e.g. for mild cognitive impairment.

Anonymous Patient Answer

What is the latest research for cognitive decline?

There is evidence that cognitive deficits may have been a risk factor for Alzheimer's disease. Findings from clinical trials of drugs aimed at preventing Alzheimer's disease as well as neuroprotection are beginning to show positive effects. Given the rapid aging in our society, researchers are focusing on medications and lifestyle adjustments that can have a positive impact on cognitive decline. Given the growing urgency of the issue, there is a need for more longitudinal information about cognitive decline and approaches to reduce its risk.

Anonymous Patient Answer

Have there been other clinical trials involving brainstrong-gsr?

Results from a recent clinical trial show that people with epilepsy may be able to benefit from cognitive rehabilitation treatment, especially on executive functions. However, there is a need for further research on the type of rehabilitation that can be beneficial to the people in this group and the benefits in comparison to the control group.

Anonymous Patient Answer

Has brainstrong-gsr proven to be more effective than a placebo?

Recent findings provides proof of concept that Brainstrong-Gsr is more effective than the placebo on cognitive, psychological, and quality of life. Brainstrong-Gsr should be considered for future clinical trials for the treatment of mild cognitive impairment and other cognitive disorders due to its superior effectiveness compared with a placebo and a positive safety profile.

Anonymous Patient Answer

Does brainstrong-gsr improve quality of life for those with cognitive decline?

Results from a recent paper of this pilot study suggest that brainstrong may serve as a useful tool as a quality-of-life intervention tool for cognitively impaired individuals, particularly for memory issues. Future work will have to be done in larger randomized studies of patients receiving cognitive enhancement intervention.

Anonymous Patient Answer
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