Table 1.
List of study activities and time points used in Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise (INHANCE). Unanticipated adverse device effects were reported as needed. Study exit was reported when the participants exited from the study.
| Study activity | Consent and screening visit (V0)a | Baseline visit (V1)b within 4 weeks of V0 | Program orientation and intervention for 10 weeks begin training within 2 weeks of V1 | Posttest visit (V2)c within 10-14 weeks of the first training session | No-contact period for 12 weeks | Follow-up visit (V3)d within 16-22 weeks of the first training session |
| Informed consent | ✓ |
|
|
|
|
|
| Inclusion and exclusion criteria | ✓ |
|
|
|
|
|
| Demographics | ✓ |
|
|
|
|
|
| Medical history | ✓ |
|
|
|
|
|
| Medications | ✓ |
|
|
|
|
|
| MoCAe | ✓ |
|
|
|
|
|
| GDS-SFf | ✓ |
|
|
|
|
|
| C-SSRSg, baseline | ✓ |
|
|
|
|
|
| MRIh and PETi imaging |
|
✓ |
|
✓ |
|
|
| NIH EXAMINERj |
|
✓ |
|
✓ |
|
✓ |
| Train-to-task assessments with heart rate variability and pupillometry |
|
✓ |
|
✓ |
|
✓ |
| C-SSRS, since last visit |
|
✓ |
|
✓ |
|
✓ |
| Medications, since the last visit |
|
✓ |
|
✓ |
|
✓ |
| Adverse effects |
|
✓ |
|
✓ |
|
✓ |
| Randomization |
|
✓ |
|
|
|
|
| Program Orientation |
|
|
✓ |
|
|
|
| Computer training |
|
|
✓ |
|
|
|
| Weekly phone check-in |
|
|
✓ |
|
|
|
aV0: consent and screening visit.
bV1: baseline visit.
cV2: posttest visit.
dV3: follow-up visit (end of study).
eMoCA: Montreal Cognitive Assessment.
fGDS-SF: Geriatric Depression Scale–Short Form.
gC-SSRS: The Columbia Suicide Severity Rating Scale.
hMRI: magnetic resonance imaging.
iPET: positron-emission tomography.
jNIH EXAMINER: National Institutes of Health Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research.