taVNS + CCT for Neurocognitive Rehab

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • taVNS

    Device

    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

    Device

    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).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: taVNS + CCTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Retention

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.

Time frame
From enrollment to the V2 post-treatment assessment (approximately 6 weeks).
2

Adherence

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.

Time frame
10 treatments (T1-T10) over max span of 14 days.
3

Acceptability

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.

Time frame
V1 (1 week pre-treatment), V2 (1 week post-treatment)

Secondary outcomes

1

Change in NIH Toolbox-Cognition Battery (NIHTB-CB) Fluid Composite

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).

Time frame
V1 (1 week pre-treatment), V2 (1 week post-treatment)
2

Change in PROMIS Cognitive Function, Depression, Anxiety, and Fatigue T-scores

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.

Time frame
V1 (1 week pre-treatment), V2 (1 week post-treatment)
3

Change in Network Functional Connectivity

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.

Time frame
V1 (1 week pre-treatment), V2 (1 week post-treatment)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

National Institutes of Health (NIH)

Collaborator