Status:
COMPLETED
SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Soterix Medical
Conditions:
Aging
Eligibility:
All Genders
65-89 years
Phase:
NA
Brief Summary
The current study will investigate methods for enhancing cognitive training (CT) effects in healthy older adults by employing a combination of interventions facilitating neural plasticity and optimizi...
Eligibility Criteria
Inclusion
- Men and women
- Age: 65 to 89 years
- English speaking
- Physically mobile
- Working memory function between 0-75th percentile determined by screening results on the POSIT Baseline Cognitive Training computerized tasks.
Exclusion
- Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
- Evidence of dementia (NACC UDS scores of 1.5 standard deviations below the mean for age, sex and education adjusted norms in a single cognitive domain on the task).
- Past opportunistic brain infection
- Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality.
- Unstable (e.g., cancer other than basal cell skin) and chronic (e.g, severe diabetes) medical conditions.
- MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).
- Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping.
- Certain prescription medications may possibly reduce effects otherwise induced by the tDCS stimulation protocol.
- Hearing or vision deficits that will not allow for standardized cognitive training stimulation; ie colorblindness, inability to hear through headphones (with or without hearing aids), macular degeneration or other significant diseases that cause severe loss of vision. If vision is corrected with lenses to appropriate levels, then participant will be eligible.
- Left handedness, as those with left-handedness have a higher percentage rate of atypical functional lateralization for brain functions, which would significantly interfere with interpretability of brain data.
- Participants with precision tDCS dosage of \>4.0mA required will be excluded due to limitations of tDCS device (maximum output of 4.0 mA). The maximum output of 4.0 mA reflects a technical limitation of the device design rather than a safety threshold.
Key Trial Info
Start Date :
January 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05377411
Start Date
January 17 2023
End Date
June 3 2024
Last Update
June 26 2025
Active Locations (1)
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1
McKnight Brain Institute
Gainesville, Florida, United States, 32610