Cognitive Complaint, Cognitive Dysfunction, Neurocognitive Function, Psychosocial Well-being
Conditions
Keywords
Transcutaneous Auricular Vagus Nerve Stimulation, Cognitive Dysfunction, Psychosocial Function, cognitive training, mindfulness meditation
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.
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
DEVICEtaVNS
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.
DEVICEComputerized 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).
Sponsors
Medical University of South Carolina
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | From enrollment to the V2 post-treatment assessment (approximately 6 weeks). | 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. |
| Adherence | 10 treatments (T1-T10) over max span of 14 days. | 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. |
| Acceptability | V1 (1 week pre-treatment), V2 (1 week post-treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in NIH Toolbox-Cognition Battery (NIHTB-CB) Fluid Composite | V1 (1 week pre-treatment), V2 (1 week post-treatment) | The NIHTB-CB is a performance-based, iPad-administered \~30-minute suite of 7 tests that ascertain abilities in different cognitive domains (e.g. executive function, episodic memory, working memory, processing speed, language). It was developed using advanced psychometric techniques to minimize measurement error and produces normed subtest and composite scores. The outcome will be the fully-corrected T-score (range T=0-100; Mean T=50, SD=10; higher scores indicate better cognition) of the Fluid Cognition Composite (normed for age and years of education). |
| Change in PROMIS Cognitive Function, Depression, Anxiety, and Fatigue T-scores | V1 (1 week pre-treatment), V2 (1 week post-treatment) | These are self-report questionnaires to which respondents rate their perceived (i.e., subjective) cognitive abilities and symptoms (i.e., depression, anxiety, fatigue) on a 5-point scale (from 1-"Not at all"; "Never" to 5-"Very much"; "Always", respectively) during the specified timeframe. It is a computer adaptive test given as a REDCap survey that yields normed T-scores (range T=0-100; Mean T=50, SD=10). Higher scores indicate more of the respective symptom. |
| Change in Network Functional Connectivity | V1 (1 week pre-treatment), V2 (1 week post-treatment) | Functional brain MRI scans will be collected while participants are at rest (i.e. rs-fMRI) during the pre-treatment and post-treatment MRI sessions. The rs-fMRI data will be used to compute functional connectivity, which is the correlation between the activity in each brain region pair over the course of the scan. Each brain region belongs to 1 of 7 functional networks (frontoparietal: FPN; default mode: DMN; dorsal attention: DAT; ventral attention: VAT; limbic: LIM; visual: VIS; somatomotor: MOT). Connectivity will be calculated as the Fisher's r-to-z transformed Pearson correlations between the BOLD time courses of each region pair within each network. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStephanie Aghamoosa, PhD
Medical University of South Carolina
Outcome results
None listed