Recruiting

taVNS & Cognitive Training

Sponsor:

Medical University of South Carolina

Code:

NCT07517237

Conditions

Psychosocial Well-being

Neurocognitive Function

Cognitive Complaint

Cognitive Dysfunction

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

taVNS

Computerized Cognitive Training

Study Details

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

Study ID

NCT07517237

Start date

Mar 12, 2026

Status verified date

Apr, 2026

Completion date

Sep 15, 2026

Anticipated

Primary completion date

Sep 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: taVNS + CCT

Interventions

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.

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).

Primary outcome measure

  • Retention [ Time Frame: From enrollment to the V2 post-treatment assessment (approximately 6 weeks). ]
  • Adherence [ Time Frame: 10 treatments (T1-T10) over max span of 14 days. ]
  • Acceptability [ Time Frame: V1 (1 week pre-treatment), V2 (1 week post-treatment) ]

Central Contacts and Locations

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

More Information

Sponsor

Medical University of South Carolina

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-04-08.