What side effects are associated with this type of intervention?

Common treatments for cognitive impairment include cognitive behavioral therapy (CBT), cognitive training programs, and non-pharmacologic interventions like exercise and bright light therapy. Known side effects of these treatments are generally minimal. For CBT and cognitive training programs, side effects may include temporary increases in anxiety or frustration as patients engage with challenging tasks. Exercise interventions can sometimes lead to physical strain or injury if not properly supervised. Bright light therapy may cause eye strain or headaches in some individuals. Overall, these treatments are considered safe with a low risk of adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of cognitive impairments, particularly in conditions like Alzheimer's disease. Notable among these are cholinesterase inhibitors such as donepezil and galantamine, which have shown promise in improving cognitive function. Memantine, an NMDA receptor antagonist, is another approved drug that helps in moderate to severe Alzheimer's by protecting neurons from glutamate toxicity. Additionally, non-pharmacological treatments like transcranial direct current stimulation (tDCS) have been explored for their potential to enhance neuroplasticity and cognitive performance, although more research is needed to establish their efficacy.

What other types of research exist?

Promising, novel alternatives to digital cognitive training programs for enhancing neuroplasticity and cognitive performance include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown potential in improving language and cognitive functions in stroke patients with aphasia. 2) Pharmacological treatments such as memantine, donepezil, and galantamine, which have been studied for their effects on cognitive function in post-stroke aphasia and Alzheimer's disease. 3) Behavioral therapies, including cognitive-behavioral therapy (CBT) and structured skills training programs, which have been effective in managing symptoms and improving cognitive outcomes in various conditions.

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Behavioural Intervention

Guided Digital Mindfulness Programs for Brain Health (BRIGHT-Mind Trial)

N/A

Recruiting

Led By Kevin Madore, PhD

Research Sponsored by Lumos Labs, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study day 0 to study day 84

Awards & highlights

BRIGHT-Mind Trial Summary

This trial looks at how digital programs can help improve mental health through improved thinking and brain changes.

Who is the study for?

This trial is for adults aged 25-80 who can use a computer with internet and video conferencing tools, understand English, and follow instructions. They must be able to see well enough (with glasses if needed) to work on a computer but cannot have had seizures or significant tics, severe mental health conditions, neurological disorders like Alzheimer's or Parkinson's, or any recent medical condition that could affect the study results. They should live independently and not be pregnant.Check my eligibility

What is being tested?

The study tests two digital programs designed to stimulate the mind. It aims to improve thinking skills and measure changes in brain structure and function through daily online activities participants complete at home using their own computers.See study design

What are the potential side effects?

Since this trial involves digital programs for cognitive stimulation rather than medication, traditional side effects are not expected. However, individuals sensitive to bright screens may experience headaches, dizziness or nausea.

BRIGHT-Mind Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study day 0 to study day 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study day 0 to study day 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 0 to study day 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Composite from Creyos (formerly Cambridge Brain Sciences)

Secondary outcome measures

Concentration Domain Score from Creyos

Memory Domain Score from Creyos

Planning Domain Score from Creyos

+4 more

BRIGHT-Mind Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort BExperimental Treatment2 Interventions

Remote + Imaging subjects

Group II: Cohort AExperimental Treatment2 Interventions

Remote-Only subjects

Do I qualify?Apply below to find out

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

Digital cognitive training programs enhance cognition by promoting neuroplasticity through structured, repetitive tasks that stimulate specific cognitive functions like memory and attention. This is crucial for cognition patients as it helps form new neural connections, potentially mitigating cognitive decline and improving overall cognitive performance and quality of life.

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Who is running the clinical trial?

Lumos Labs, Inc.Lead Sponsor

14 Previous Clinical Trials

15,402 Total Patients Enrolled

Kevin Madore, PhDPrincipal InvestigatorLumos Labs, Inc.

1 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

Digital Program 1 (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05912556 — N/A

Cognition Research Study Groups: Cohort A, Cohort B

~0 spots leftby Jul 2024

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