SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults

Aging Clinical Trial

Official title:

SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05377411
• Other study ID #: IRB202100953
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: August 19, 2024

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 19, 2024
• Est. primary completion date: August 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

Device:
• tDCS
During tDCS, a weak electrical current is applied to the scalp that penetrates skin, bone, CSF and the meninges to stimulate underlying cortical and subcortical tissue

Behavioral:
• cognitive training
Cognitive Training (CT) will involve up to 10 hours of training over 2-weeks (10 days). CT employs a PositScience BrainHQ suite via its researcher portal. These tasks are web-based and multi-platform (i.e., Windows, Mac). Participants will be randomly assigned to training on 4 tasks focusing on working memory or 4 tasks focusing on attention/speed of processing.

Locations

Country	Name	City	State
United States	McKnight Brain Institute	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Soterix Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	N-Back working memory	Change in working memory performance on the N back working memory MRI task from baseline to post test will be assessed. Post test will occur approximately two weeks following baseline.; The N-back working memory task will be completed during the MRI scan at both baseline and post test assessments. Working memory performance will be defined as a composite of reaction time and accuracy for two back trials.	Baseline to post test. Post test will occur approximately two weeks following baseline.