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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McKnight Brain Institute

Gainesville, Florida, United States, 32610