taVNS + CCT for Neurocognitive Rehab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: taVNS, Computerized Cognitive Training.
- Who it may be relevant to
- Registry conditions: Psychosocial Well-being, Neurocognitive Function, Cognitive Complaint, Cognitive Dysfunction. Basic parameters: 45 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Combining At-Home Transcutaneous Auricular Vagus Nerve Stimulation and Computerized Cognitive Training for Neurocognitive Rehabilitation
Overview
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.
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.
Interventions
- 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).
Primary outcome measures
- 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)]
Secondary outcome measures (3)
- Change in NIH Toolbox-Cognition Battery (NIHTB-CB) Fluid Composite [Time frame: V1 (1 week pre-treatment), V2 (1 week post-treatment)]
- Change in PROMIS Cognitive Function, Depression, Anxiety, and Fatigue T-scores [Time frame: V1 (1 week pre-treatment), V2 (1 week post-treatment)]
- Change in Network Functional Connectivity [Time frame: V1 (1 week pre-treatment), V2 (1 week post-treatment)]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT07517237 · Pro00144863