SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults

Sponsor

University of Florida (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05377411

Collaborator

Soterix Medical (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging	Device: tDCS Behavioral: cognitive training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Optimized tDCS + Cognitive Training 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.	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.
Sham Comparator: Sham tDCS + Cognitive Training 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 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.

Arm

Intervention/Treatment

Experimental: Optimized tDCS + Cognitive Training

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.

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.

Sham Comparator: Sham tDCS + Cognitive Training

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

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

Outcome Measures

Primary Outcome Measures

N-Back working memory [Baseline to post test. Post test will occur approximately two weeks following baseline.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McKnight Brain Institute	Gainesville	Florida	United States	32610

Sponsors and Collaborators

University of Florida
Soterix Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT05377411

Other Study ID Numbers:

IRB202100953

First Posted:

May 17, 2022

Last Update Posted:

Jul 11, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of Florida

tdcs

cognitive training

Study Results

No Results Posted as of Jul 11, 2022