20 Participants NeededMy employer runs this trial

taVNS + Computerized Cognitive Training for Neurocognitive Function

(NeuroHUB Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
Must be taking: Cholinesterase inhibitors, NMDA antagonists
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining two treatments can enhance thinking abilities and mood. The treatments include transcutaneous auricular vagus nerve stimulation (taVNS), a special type of nerve stimulation, and computer-based brain exercises that participants will complete at home. It suits individuals aged 45 to 80 who have experienced changes in memory or attention affecting daily life. Participants must maintain a stable medication routine and have reliable Wi-Fi access and a smartphone or tablet. As an unphased trial, this study provides a unique opportunity to explore innovative treatments from home.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications. The trial requires that you stay on a stable dose of your medications for at least 4 weeks before joining and throughout the study.

What prior data suggests that this combination of taVNS and computerized cognitive training is safe?

Previous studies have shown that transcutaneous auricular vagus nerve stimulation (taVNS) is safe and well-tolerated. Research indicates that taVNS can enhance thinking skills, such as memory and attention, without major safety concerns. One study carefully monitored safety and reported no significant negative reactions after treatment sessions. Overall, taVNS is considered a non-invasive and safe method to boost cognitive performance.12345

Why are researchers excited about this trial?

Researchers are excited about taVNS combined with Computerized Cognitive Training (CCT) because it offers a novel approach to enhancing neurocognitive function. Unlike traditional methods, which often rely on medications or basic cognitive exercises, this treatment uses transcutaneous auricular vagus nerve stimulation (taVNS) to non-invasively stimulate the vagus nerve through the ear. This unique mechanism could potentially enhance brain plasticity and improve cognitive processing more effectively than current options. By integrating this with CCT, researchers hope to amplify the benefits, paving the way for more effective and faster cognitive improvements.

What evidence suggests that this trial's treatments could be effective for improving thinking abilities and mood?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS), which participants in this trial will receive, can enhance thinking skills and memory. Studies have found that taVNS boosts brain activity linked to improved focus and problem-solving. It also appears to enhance mood by helping the body manage stress more effectively, as indicated by increased heart rate variability. In this trial, taVNS combines with computerized cognitive training (CCT), which uses targeted exercises to improve thinking skills. Together, these treatments hold promise for enhancing mental abilities and mood.23467

Who Is on the Research Team?

SA

Stephanie Aghamoosa, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for people aged 45-80 who have noticed changes in their thinking or memory for at least 6 months that affect daily life. Participants need to have stable medication, be able to use a smartphone or tablet with Wi-Fi, and must not have dementia, certain medical conditions, or MRI/taVNS restrictions.

Inclusion Criteria

I am between 45 and 80 years old.
Access to reliable Wi-Fi and a Bluetooth-enabled mobile phone or tablet with internet connection capable of supporting study procedures
I have noticed changes in my thinking or memory for at least 6 months that affect my daily life.
See 2 more

Exclusion Criteria

Positive pregnancy test for female participants if still menstruating within the past 12 months.
Prior diagnosis of Mild Cognitive Impairment or Dementia
taVNS contraindications
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (virtual)

Treatment

Participants self-administer transcutaneous auricular vagus nerve stimulation (taVNS) with computerized cognitive training (CCT) at home

2 weeks
10 sessions (self-administered)

Post-treatment Assessment

Participants undergo post-treatment assessments of thinking abilities, mood, and brain MRIs

1 week
1 visit (in-person)

Follow-up

Participants are monitored for retention, adherence, and acceptability of the treatment

2 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Computerized Cognitive Training
  • taVNS

Trial Overview

The study tests if combining home-based ear nerve stimulation (taVNS) with computer brain training can improve thinking skills and mood. Participants will do both treatments at home and complete assessments before and after the program.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: taVNS + CCTExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Citations

The efficacy and safety of transcutaneous auricular vagus ...

Both vagus nerve stimulation and auriculotherapy are effective in improving cognitive functions. •. It demonstrates that taVNS can improve cognitive performance ...

Transcutaneous auricular vagus nerve stimulation may ... - PMC

The primary outcome was cognition operationalized by global cognitive functioning and domain-specific cognitive functions. 2.3. Systematic ...

Impact of transcutaneous auricular vagus nerve stimulation ...

This study aimed to evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) on cognitive flexibility under different ...

Auricular Transcutaneous Vagus Nerve Stimulation ...

We show that atVNS specifically modulates WM gate closing and thus specifically modulates neural mechanisms enabling the maintenance of information in WM.

Effects of taVNS on physiological responses and cognitive ...

Transcutaneous auricular vagus nerve stimulation increased heart rate variability and sympathetic electrodermal activity during the stimulation.

NCT07517237 | taVNS + CCT for Neurocognitive Rehab

This is a non-randomized, single arm pilot study of a 2-week at-home treatment combining transcutaneous auricular vagus nerve stimulation (taVNS) ...

Transcutaneous Auricular Vagus Nerve Stimulation for ...

In this randomized clinical trial, taVNS significantly reduced insomnia severity. Clinically meaningful enhancements in PSQI scores were observed compared with ...