taVNS + CCT for Neurocognitive Rehab (NeuroHUB)

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Dysfunction; Neurocognitive Function; Psychosocial Well-being; Cognitive Complaint
• Intervention / Treatment: Device: taVNS; Device: Computerized Cognitive Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Averi Jones; Phone Number: 843-608-0255; Email: jonesav@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

i. 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.

iii. Access to reliable Wi-Fi and a Bluetooth-enabled mobile phone or tablet with internet connection capable of supporting study procedures.

iv. 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.

v. 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.

Exclusion Criteria:

i. Prior diagnosis of Mild Cognitive Impairment or Dementia (NIA-AA) or Mild or Major Neurocognitive Disorder (DSM-5).

ii. taVNS contraindications (e.g., history of seizures, history of trauma or damage to ear, reduced/impaired sensation in the ear).

iii. 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.

v. Enrolled in a clinical trial or has received an investigational medication or device in the last 30 days that may impact cognition or mood.

vi. For female participants, a positive pregnancy test if still menstruating within the past 12 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: taVNS + CCT

Device: taVNS; 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.; Device: Computerized Cognitive Training; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the V2 post-treatment assessment (approximately 6 weeks).
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.	10 treatments (T1-T10) over max span of 14 days.
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.	V1 (1 week pre-treatment), V2 (1 week post-treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	V1 (1 week pre-treatment), V2 (1 week post-treatment)
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.	V1 (1 week pre-treatment), V2 (1 week post-treatment)
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.	V1 (1 week pre-treatment), V2 (1 week post-treatment)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Stephanie Aghamoosa, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cognitive training; Psychosocial Function; mindfulness meditation; Cognitive Dysfunction; Transcutaneous Auricular Vagus Nerve Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: Pro00144863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data may be shared in publications, ClinicalTrials.gov, or data repositories.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes