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Psychosocial Well-beingNeuroHUBNCT07517237

taVNS + CCT for Neurocognitive Rehab

A study testing taVNS and Computerized Cognitive Training in people with Psychosocial Well-being and Neurocognitive Function, run by Medical University of South Carolina at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to investigate whether combining transcutaneous auricular vagus nerve stimulation (taVNS) with computerized cognitive training might help improve thinking abilities and mood. Read more about this study

Who is it for?
Ages 45 to 80 years
What is being tested?
taVNS and Computerized Cognitive Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
12 Mar 2026to 26 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages 45-80 (inclusive) ii. Adequate sensorimotor function (including motor function of dominant hand to complete CCT) and verbal expressive abilities to complete all assessments.
  • Access to reliable Wi-Fi and a Bluetooth-enabled mobile phone or tablet with internet connection capable of supporting study procedures.
  • Self-reported change in cognitive functioning (e.g., memory, attention, thinking abilities) compared to prior functioning, persisting ≥ 6 months and associated with concern and/or impact on daily functioning.
  • Is on fixed pharmacotherapy (i.e. stable dose of medication/s) for ≥ 4 weeks before enrollment, and expected to remain stable throughout study participation. This includes, but is not limited to, cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants.

Who cannot join

  • Prior diagnosis of Mild Cognitive Impairment or Dementia (NIA-AA) or Mild or Major Neurocognitive Disorder (DSM-5).
  • taVNS contraindications (e.g., history of seizures, history of trauma or damage to ear, reduced/impaired sensation in the ear).
  • MRI contraindications (e.g., ferromagnetic implants, claustrophobia). iv. Presence of a neurological, medical, or psychiatric condition that is acute, unstable, or severe, and that, in the judgment of the study investigators, would significantly interfere with safe participation, valid assessment of cognition or mood, or interpretation of study outcomes.
  • Enrolled in a clinical trial or has received an investigational medication or device in the last 30 days that may impact cognition or mood.
  • For female participants, a positive pregnancy test if still menstruating within the past 12 months.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Averi Jones, 843-608-0255, jonesav@musc.edu

    Recruiting

Other trials in United States

About this study

Official title: Combining At-Home Transcutaneous Auricular Vagus Nerve Stimulation and Computerized Cognitive Training for Neurocognitive Rehabilitation

The purpose of this study is to investigate whether combining transcutaneous auricular vagus nerve stimulation (taVNS) with computerized cognitive training might help improve thinking abilities and mood. Participants will self-administer these treatment in their homes and undergo pre- and post-treatment assessments of thinking abilities and mood and brain MRIs.

Read the detailed description

This is a non-randomized, single arm pilot study of a 2-week at-home treatment combining transcutaneous auricular vagus nerve stimulation (taVNS) with computerized cognitive training (CCT) in people with subjective cognitive and psychosocial complaints. The primary objectives are to evaluate the feasibility, acceptability, and preliminary effects of this treatment on cognition, mood, psychosocial function, and brain function.

Being tested
taVNS, Computerized Cognitive Training
Keywords
Transcutaneous Auricular Vagus Nerve Stimulation, Cognitive Dysfunction, Psychosocial Function, cognitive training, mindfulness meditation
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • taVNSDevice

    A Soterix Medical Handheld home-based taVNS device combined with web-based adaptive computerized cognitive training (CCT) will be self-administered for 10, 1 hour treatment sessions at home. CCT will be accessed via the web from a tablet or computer. The premise of a combined approach is that taVNS "primes" brain networks that are then engaged by CCT, synergistically enhancing cognitive benefits.

  • Computerized Cognitive TrainingDevice

    CCT will be delivered through the online BrainHQ platform. Participants will engage in adaptive visual speed of processing training for approx. 30 minutes per session (10 sessions, total CCT time = 300 min).

Study groups in NCT07517237
Study groupRoleWhat they receive
taVNS + CCTExperimentalNot described
Receives: Device: taVNS; Device: Computerized Cognitive Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention

    Percent of participants who completed all study procedures(i.e., V1 pre-treatment assessments, all 10 treatment sessions, and V2 post-treatment assessments). This will be calculated as a binary count (1=yes, 0=no) of completers divided by the total number of participants.

    Measured: From enrollment to the V2 post-treatment assessment (approximately 6 weeks).

  2. Adherence

    Percent of treatment sessions completed. This will be calculated as the number of full treatment sessions completed by each participant divided by the prescribed number of sessions.

    Measured: 10 treatments (T1-T10) over max span of 14 days.

  3. Acceptability

    Ratings of treatment acceptability on the Theoretical Framework of Acceptability (TFA) Questionnaire. The TFA is a self-report measure on which participants rate their perceptions of treatment acceptability via 5-point Likert-scale ratings on 8 items regarding the following: affective attitude, burden, perceived effectiveness, intervention coherence, self-efficacy, opportunity costs, ethicality, and general acceptability. Item scores will be averaged (ranging from 0-5), with higher scores indicating greater intervention acceptability.

    Measured: V1 (1 week pre-treatment), V2 (1 week post-treatment)

Secondary outcomes (3)

  1. Change in NIH Toolbox-Cognition Battery (NIHTB-CB) Fluid Composite

    The NIHTB-CB is a performance-based, iPad-administered ~30-minute suite of 7 tests that ascertain abilities in different cognitive domains (e.g. executive function, episodic memory, working memory, processing speed, language). It was developed using advanced psychometric techniques to minimize measurement error and produces normed subtest and composite scores. The outcome will be the fully-corrected T-score (range T=0-100; Mean T=50, SD=10; higher scores indicate better cognition) of the Fluid Cognition Composite (normed for age and years of education).

    Measured: V1 (1 week pre-treatment), V2 (1 week post-treatment)

  2. Change in PROMIS Cognitive Function, Depression, Anxiety, and Fatigue T-scores

    These are self-report questionnaires to which respondents rate their perceived (i.e., subjective) cognitive abilities and symptoms (i.e., depression, anxiety, fatigue) on a 5-point scale (from 1-"Not at all"; "Never" to 5-"Very much"; "Always", respectively) during the specified timeframe. It is a computer adaptive test given as a REDCap survey that yields normed T-scores (range T=0-100; Mean T=50, SD=10). Higher scores indicate more of the respective symptom.

    Measured: V1 (1 week pre-treatment), V2 (1 week post-treatment)

  3. Change in Network Functional Connectivity

    Functional brain MRI scans will be collected while participants are at rest (i.e. rs-fMRI) during the pre-treatment and post-treatment MRI sessions. The rs-fMRI data will be used to compute functional connectivity, which is the correlation between the activity in each brain region pair over the course of the scan. Each brain region belongs to 1 of 7 functional networks (frontoparietal: FPN; default mode: DMN; dorsal attention: DAT; ventral attention: VAT; limbic: LIM; visual: VIS; somatomotor: MOT). Connectivity will be calculated as the Fisher's r-to-z transformed Pearson correlations between the BOLD time courses of each region pair within each network.

    Measured: V1 (1 week pre-treatment), V2 (1 week post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2026
  2. Study start12 Mar 2026
  3. Primary completion26 Oct 2026 (estimated)
  4. Study completion26 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07517237
Sponsor's protocol ID
Pro00144863
Acronym
NeuroHUB
Status last verified
Apr 2026
First submitted
30 Mar 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified data may be shared in publications, ClinicalTrials.gov, or data repositories.

Questions about this trial

What is this clinical trial studying?

A study testing taVNS and Computerized Cognitive Training in people with Psychosocial Well-being and Neurocognitive Function, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention (time frame: From enrollment to the V2 post-treatment assessment (approximately 6 weeks).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07517237.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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