At-home ear vagus nerve stimulation plus computer brain training for thinking and mood

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-randomized, single-arm pilot of a 2-week at-home intervention pairing transcutaneous auricular vagus nerve stimulation (taVNS) with computerized cognitive training (CCT) in adults with subjective cognitive and psychosocial complaints. Participants self-administer the taVNS and complete CCT at home and undergo standardized cognitive and mood assessments before and after the treatment period. Brain MRI scans are obtained at baseline and after the intervention to explore treatment-related changes in brain function. The primary aims are to determine feasibility and acceptability and to collect preliminary data on cognitive, mood, psychosocial, and neural outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Stephanie Aghamoosa, PhD — Medical University of South Carolina

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.