Clinical trial NCT05377411: SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults
Official title: SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: tdcs
cognitive training
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Soterix Medical
First posted: 2022-05-17
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Arm 1 will receive optimized tDCS paired with cognitive training. Arm 2 will receive sham tDCS paired with cognitive training.
Primary purpose: TREATMENT

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 optimizing readiness for learning. A pilot randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). A precision dosing algorithm will be used to determine the appropriate levels of current and location of electrodes to deliver current using tDCS.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: N-Back working memory
timeFrame: Baseline to post test. Post test will occur approximately two weeks following baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: McKnight Brain Institute
state: Florida
Study officials:
References: