Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems for Cognitive Changes

1
Effectiveness
1
Safety
Tufts University, Boston, MA
Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems - Other
Eligibility
18+
All Sexes
Eligible conditions
Cognitive Changes

Study Summary

This study is evaluating whether a brain stimulation device can improve cognitive function.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems will improve 3 primary outcomes in patients with Cognitive Changes. Measurement will happen over the course of 36 weeks.

36 weeks
Verbal cognitive performance
Visual perceptual performance
72 weeks
Spatial cognitive performance

Trial Safety

Trial Design

2 Treatment Groups

Sham High-Definition Stimulation
Active High-Definition Stimulation
Placebo group

This trial requires 1500 total participants across 2 different treatment groups

This trial involves 2 different treatments. Stimulation Via Soterix Medical Or Neuroelectrics Noninvasive Brain Stimulation Systems is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Active High-Definition Stimulation
Other
Active high-definition stimulation of targeted brain regions involved in perception and cognition.
Sham High-Definition Stimulation
Other
Sham high-definition stimulation of targeted brain regions involved in perception and cognition.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 72 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 72 weeks for reporting.

Who is running the study

Principal Investigator
T. B.
Tad Brunye, PI
Tufts University

Closest Location

Tufts University - Boston, MA

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
- Between ages of 18-65.

Patient Q&A Section

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

Can cognitive changes be cured?

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If treatment is effective in suppressing psychosis, which can be verified empirically, patients who have been treated with antipsychotics can expect improvement of cognitive deficits caused by psychosis. If improvement is confirmed, the treatments are likely to be considered curative.

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What causes cognitive changes?

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There are three general groups to whom this article refers: Alzheimer's (AD) diseases, dementia, and amnestic disorder. The cognitive deficits associated with these diseases occur even in mild disease, and reflect neurodegenerative changes. The two main types of dementia are mild cognitive impairment (MCI) and dementia. Although MCI is a less conclusive term because it occurs before a diagnosis of dementia, both dementia syndromes involve significant brain cell loss. These types of brain degeneration may explain the cognitive impairments in patients who are not formally diagnosed with AD. Both types of dementia can result in alterations in brain structure and/or functionality.

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How many people get cognitive changes a year in the United States?

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About 11 million Americans are diagnosed with some form of dementia. This has reached the peak of about 1.4 million Americans with Alzheimer's, and about 10 million with Parkinson's dementia. These two dementias make up 25% of dementia diagnoses. Dementia, however, is not a disease limited to the elderly. About 35% of all Americans over 65 have some sort of dementia. Cognitive decline occurs even with age, but with varying strengths and frequencies of clinical onset and degree of cognitive impairment, and the rates of clinical and functional decline vary by the form of dementia. About 10 million Americans have some form of dementia. The rates of dementia are almost three times more prevalent in the U.S. than in Africa and Europe.

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What are common treatments for cognitive changes?

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Cognitively active treatments can be administered to patients who may not respond to cognitively inactive treatments or be excluded from cognitively inactive treatment. Cognitively active treatments that target neuroplastic changes are most effective, while cognitively inactive treatments are not effective for treatment of MCI and dementia. Cognitively inactive treatments that target neuroplastic changes are not effective for treatment of MCI or dementia.

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What are the signs of cognitive changes?

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Signs of cognitive impairment may vary with a patient's specific neurological condition. However, the common symptoms that can indicate cognitive changes are dizziness or nausea.\n\nCognitive abilities vary during a patient's lifetime. If a patient lives an extended period of time, he or she may develop a higher order of cognitive dysfunction. Cognitive ability may be a factor in the development of some diseases.\n\nThe most common diseases that cause a significant decrease in cognitive ability include alcoholism, schizophrenia, traumatic brain injury, and multiple sclerosis.\n\nThere are more diseases for which the presence or absence of cognitive abnormalities can be used as a clinical marker, but the precise nature of these deficits is uncertain, especially in cases of borderline symptoms.

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What is cognitive changes?

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Most of the present study participants reported improvement as a result of treatment at the end of a four-week study. The effects of treatment have been maintained in the longer term, up to a year after the last treatment session. Recent findings also indicated that the effects of treatment on cognitive functioning can be enhanced through follow-up. Long-term studies are needed to identify the optimum treatment strategy to reduce cognitive dysfunction and its impact on functioning.

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Has stimulation via soterix medical or neuroelectrics noninvasive brain stimulation systems proven to be more effective than a placebo?

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Stimulatory benefits have been demonstrated in this case study in a nonclinical setting for sotato-cognitive improvement with both tDCS and NBS. Further studies are needed to validate these results in patients with severe neuropsychiatric conditions.

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What does stimulation via soterix medical or neuroelectrics noninvasive brain stimulation systems usually treat?

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Stimulation via the Soterix devices, in addition to conventional therapy for mild to moderate AD, may improve cognitive function. The Soterix device is also designed to improve executive function and attention in patients, which may be a potential additional benefit in addition to the improvement in cognitive function.

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Who should consider clinical trials for cognitive changes?

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Recent findings indicate that while a cognitive functional profile may be associated with the presence of tinnitus, this profile alone may not be adequate for recommending the use of clinical trials over alternative treatments to address tinnitus. In addition, this finding is particularly relevant to clinicians who recommend clinical trials to their patients because this subset of patients may be better suited to treatment, which may improve their quality of life. However, the evidence base is still in its early stages, so additional research should be done to clarify these conclusions.

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What are the common side effects of stimulation via soterix medical or neuroelectrics noninvasive brain stimulation systems?

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Stimulation by the Soterix Brain Stimulation System was well tolerated. The most frequently reported adverse events were headache and fatigue. Most of the other side effects were mild and did not need to be immediately addressed.

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What is the primary cause of cognitive changes?

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Primary aging and vascular insult have been linked to the onset of focal brain infarcts. Brain lesions and ischemic injuries are not always the cause of cognitive changes. As one moves away from focal infarct lesions, [brain lesions and lesions, which are part of diffuse dementias, are the most likely cause of cognitive changes] in people with Alzheimer's disease. It is difficult to differentiate between primary aging and brain lesions/infarcts. The causes of cognitive changes in Alzheimer's patients depend on the patient's age, gender, and initial cognitive scores. Many patients have both primary global dementias and focal injuries.

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What is stimulation via soterix medical or neuroelectrics noninvasive brain stimulation systems?

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Soterix has not shown to have any statistically significant effect on cognition. Soterix medical brain stimulation devices are not indicated, as they seem to be less effective than soterix neuroelectrics brain stimulation devices.

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