taVNS + CCT for Neurocognitive Rehab

NCT07517237 | Recruiting FDA Device

• 1 other identifier: Pro00144863
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. Participants will self-administer these treatment in their homes and undergo pre- and post-treatment assessments of thinking abilities and mood and brain MRIs.

Conditions

Psychosocial Well-being; Neurocognitive Function; Cognitive Complaint; Cognitive Dysfunction

Keywords

Transcutaneous Auricular Vagus Nerve Stimulation; Cognitive Dysfunction; Psychosocial Function; cognitive training; mindfulness meditation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

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

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

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

• Change in Network Functional Connectivity

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

Study Arms (1)

taVNS + CCT

EXPERIMENTAL

Device: taVNS; Device: Computerized Cognitive Training

Interventions

taVNS DEVICE

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.

taVNS + CCT

Computerized Cognitive Training DEVICE

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).

taVNS + CCT

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• Medical University of South Carolina: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Stephanie Aghamoosa, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Faculty

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 8, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)