SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults

NCT05377411 | Completed Results FDA Device

• 1 other identifier: IRB202100953
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

tdcs; cognitive training

Outcome Measures

Primary Outcomes (1)

• 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. Specifically Target Accuracy percent correct and average correct target reaction time in milliseconds. Percent changes were calculated for Target Accuracy and Reaction Time in the form of (post test-pre test)/pre test. Since the direction of improvement is opposite for the two variables (i.e. higher Accuracy is better and lower Reaction Time is better), the reaction time percent change was multiplied by -1 to ensure a larger number indicated improved performance. To create a composite these two percent changes (Target Accuracy and Reaction Time) were averaged into a single value.

  Baseline to post test. Post test will occur approximately two weeks following baseline.

Study Arms (2)

Optimized tDCS + Cognitive Training

EXPERIMENTAL

A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of up to 4.0mA direct current through two biocarbon rubber electrodes covered with at least 5mm-thick conductive electrode paste buffer, and placed over the optimized locations based on the international 10-20 system by using a combination of 10-20 EEG cap measurement and a stereotactic neuronavigation system. Stereotactic neuronavigation will be used as needed and may not be used on all participants.

Device: tDCS; Behavioral: cognitive training

Sham tDCS + Cognitive Training

SHAM COMPARATOR

Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of up to 4 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.

Device: tDCS; Behavioral: cognitive training

Interventions

tDCS DEVICE

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

Optimized tDCS + Cognitive Training; Sham tDCS + Cognitive Training

cognitive training BEHAVIORAL

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.

Optimized tDCS + Cognitive Training; Sham tDCS + Cognitive Training

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Soterix Medical: collaborator

Study Sites (1)

McKnight Brain Institute

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation; Cognitive Training

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Aprinda Queen
• Organization: University of Florida

aprinda.indahlas@phhp.ufl.edu

(352) 294-8990

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Procedures for tDCS will be identical for both arms with the exception of the amount of current delivered. Neither the participant nor the experimenter will know the amount of current delivered during tDCS sessions. Web-based permuted block randomization to randomly divide participants into the two groups.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1 will receive optimized tDCS paired with cognitive training. Arm 2 will receive sham tDCS paired with cognitive training.

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: May 17, 2022
• Study Start: January 17, 2023
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2024-10

Locations

US (1)