At-home ear vagus nerve stimulation plus computer brain training for thinking and mood
Combining At-Home Transcutaneous Auricular Vagus Nerve Stimulation and Computerized Cognitive Training for Neurocognitive Rehabilitation
This study will try at-home transcutaneous auricular vagus nerve stimulation combined with computerized cognitive training to see if it helps people aged 45-80 with self-reported cognitive changes improve thinking and mood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT07517237 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 45-80 with a self-reported change in cognition lasting at least six months that affects daily life, who have adequate sensorimotor and language ability, stable medications, reliable Wi‑Fi and a Bluetooth-enabled phone or tablet, and no prior diagnosis of MCI or dementia are ideal candidates.
Not a fit: People with a prior diagnosis of mild cognitive impairment or dementia, unstable medications, major sensory or motor impairments preventing device use, contraindications to taVNS, or who cannot travel to Charleston, SC for MRI and study visits are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, this combined at-home approach could provide an accessible, noninvasive option to improve thinking, mood, and daily functioning without frequent clinic visits.
How similar studies have performed: Small studies of taVNS and of computerized cognitive training have shown mixed but sometimes promising effects separately, while the specific combination used here is novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie Aghamoosa, PhD — Medical University of South Carolina
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.