Multiparameter Optimized tES for Memory in Aging

NCT06491264 | Withdrawn FDA Device

• 1 other identifier: Pro00133951
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

With an aging population worldwide, it is critical to develop effective interventions promoting healthy cognitive aging. Transcranial electrical stimulation (tES) is a promising but not fully realized noninvasive brain stimulation approach that could improve memory. This study investigates the behavioral and electrocortical effects of personalized tES in aging to determine whether whether optimal dosing, electrode placements, and waveforms elicit stronger responses.

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (2)

• Electrocortical EEG changes pre- to post-tES

  Observe effects of each tES condition within each of the 5 sessions, as measured by TMS-EEG

  1 year

• N-back working memory changes pre- to post-tES

  Observe effects of each tES condition within each of the 5 sessions on the N-back memory task

  1 year

Secondary Outcomes (1)

• Rate of side effects from tES

  1 year

Study Arms (5)

Personalized tES stimulation #1

EXPERIMENTAL

tES will be applied with personalized parameters in condition #1 for approximately 20 minutes.

Device: Transcranial electrical stimulation

Personalized tES stimulation #2

EXPERIMENTAL

tES will be applied with personalized parameters in condition #2 for approximately 20 minutes.

Device: Transcranial electrical stimulation

Personalized tES stimulation #3

EXPERIMENTAL

tES will be applied with personalized parameters in condition #3 for approximately 20 minutes.

Device: Transcranial electrical stimulation

Standard tES

EXPERIMENTAL

Standard tES will be applied in condition #4 for approximately 20 minutes.

Device: Transcranial electrical stimulation

Sham tES stimulation

SHAM COMPARATOR

A sham (placebo) comparison condition will be applied in condition #5 for approximately 20 minutes.

Device: Transcranial electrical stimulation

Interventions

Transcranial electrical stimulation DEVICE

We will administer active transcranial electrical stimulation in one of the 4 active stimulation conditions and 1 sham stimulation condition.

Personalized tES stimulation #1; Personalized tES stimulation #2; Personalized tES stimulation #3; Sham tES stimulation; Standard tES

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• y.o.
• Endorse good health with no history of mental or physical illness
• Willingness to adhere to the study schedule and assessments
• Able to read consent document and provide informed consent.
• English is a first or primary fluent language.

You may not qualify if:

• Any current psychiatric diagnosis or current Clinical Global Impression ratings of psychiatric illness \> 1
• Neurodevelopmental disorders, history of Central Nervous System (CNS) disease, concussion, overnight hospitalization, or other neurologic sequela, tumors, seizures, meningitis, encephalitis, or abnormal CT or MRI of the brain
• Any psychotropic medication is taken within 5 half-lives of procedure time
• Any head trauma resulting in loss of consciousness
• Visual impairment (except the use of glasses)
• Inability to complete cognitive testing
• Active participation or plan for enrollment in another evidence-based clinical trial affecting the psychosocial function
• Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) or taking medications including stimulants, modafinil, thyroid medication, or steroids
• Implanted devices/ferrous metal of any kind
• History of seizure or epilepsy, currently taking medications that lower seizure thresholds
• Claustrophobia or other conditions that would prevent the MRI assessment.
• Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term).
• Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precautions should be taken. Examples of acceptable methods of birth control for participants involved in the study include birth control pills, patches, Intrauterine Devices (IUD), condoms, sponges, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant.
• Inability to adhere to the treatment schedule.
• Inability to fit the wearable device to the user's head.

Sponsors & Collaborators

• Medical University of South Carolina: lead

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Kevin Caulfield, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind, sham-controlled
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: In this within-subjects design, participants will each receive 5 sessions of tES in a counterbalanced order. tES will be applied using different stimulation intensities that are personalized to each person using MRI scans. tES will also have different 4 different waveforms (theta, gamma, theta-gamma ranges or none).

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: July 9, 2024
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02