What side effects are associated with this type of intervention?

Non-invasive brain training methods, such as cognitive behavioral therapy (CBT) and other brain training strategies, are commonly used to enhance cognitive skills and memory processes in individuals with Mild Cognitive Impairment (MCI). These treatments are generally well-tolerated with minimal side effects. However, some individuals may experience temporary increases in anxiety or frustration, particularly if they find the exercises challenging. Unlike pharmacological treatments, non-invasive brain training does not carry risks of drug-related side effects such as gastrointestinal issues, cardiovascular events, or dependency.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of cognitive impairment, particularly in Alzheimer's disease, which often overlaps with Mild Cognitive Impairment (MCI). These include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, as well as the NMDA receptor antagonist memantine. While non-invasive brain training techniques such as transcranial magnetic stimulation (TMS) and cognitive training exercises show promise in enhancing cognitive skills and memory processes, they are not yet FDA-approved for MCI. Current research continues to explore their efficacy and potential for future approval.

What other types of research exist?

Promising novel alternatives to non-invasive brain training for MCI patients include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown potential in improving cognitive functions; 2) Intensive language training and constraint-induced aphasia therapy, which have demonstrated long-term stability in language function improvements; 3) Epidural cortical stimulation as an adjunctive treatment for non-fluent aphasia; and 4) Augmentation of traditional therapies with advanced techniques like transcranial magnetic stimulation (TMS) and neurofeedback.

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Behavioural Intervention

Neurofeedback for Mild Cognitive Impairment (TUNe Trial)

N/A

Waitlist Available

Led By Yang Jiang, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Veterans diagnosed with schizophrenia

Veterans diagnosed with PTSD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates using a special headset that reads brain activity to help aging Veterans improve their memory. The headset provides real-time feedback, allowing Veterans to train their brains. This approach targets Veterans at risk for memory problems due to combat stress and aims to offer a non-drug solution to cognitive decline.

Who is the study for?

This trial is for veterans aged 60 and older who may be experiencing memory problems. It's not open to those with PTSD, epilepsy, schizophrenia, or those using benzodiazepines.

What is being tested?

The study tests neurofeedback as a non-invasive brain training method aimed at improving memory in aging veterans who are at risk of mild cognitive impairment and dementia.

What are the potential side effects?

Neurofeedback is generally considered safe but can sometimes cause temporary discomfort like headache, fatigue, or anxiety during or after sessions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a veteran diagnosed with schizophrenia.

Select...

I am a veteran diagnosed with PTSD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

EEG alpha band

Secondary study objectives

California Verbal Learning Test

memory-related potentials

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MCI patientsExperimental Treatment1 Intervention

Vets with mild cognitive impairment

Group II: NCActive Control1 Intervention

Normal healthy Veterans

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neurofeedback

2019

Completed Phase 3

~1100

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Non-invasive brain training methods, such as cognitive rehabilitation and neurofeedback, aim to enhance cognitive skills and memory processes in patients with Mild Cognitive Impairment (MCI). These treatments work by stimulating neural plasticity, which is the brain's ability to reorganize itself by forming new neural connections. This is particularly important for MCI patients as it can help to slow down cognitive decline and improve memory functions, potentially delaying the progression to more severe forms of dementia. By engaging in targeted cognitive exercises, patients can strengthen specific brain regions involved in memory and cognition, thereby improving their overall cognitive health and quality of life.

Observations and suggestions on antidementia drug development.Are there protective treatments for cognitive decline in MS?