Neuromodulation Effects in Older Adults

NCT ID: NCT06665022

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2024-12-01

Brief Summary

The current study is a mechanistic study to evaluate working memory gains from application of transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control

Detailed Description

The current study is a mechanistic study to evaluate working memory gains with transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control. The proposed study investigates the effects of acute (one-time) tDCS application on working memory gains (i.e., behavior and functional) by evaluating brain structure and cognitive function relationships. tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and enhances neural plasticity when paired with a training task. A mechanistic, in-scanner, crossover design tDCS study (active and sham stimulation) with 2milliamps (mA) fixed dosing application will enroll 110 participants comprising 55 cognitively normal/healthy older adults and 55 older adults with MCI. The study will employ multi-modal neuroimaging (structural and functional data), person-specific computational models, and machine learning to elucidate acute tDCS effects on working memory. Change in cognitive function (i.e., working memory performance) will be quantified using working memory tasks and magnetic resonance imaging (MRI). The investigators will compare changes in working memory performance resulting from active tDCS versus sham tDCS during 2-back task compared to 0-back task.

The investigators will test the following hypotheses:

1. Acute tDCS will increase working memory performance during active tDCS and larger degree of brain atrophy seen in MCI patients will significantly decrease current intensity in stimulated brain regions.

2. Acute tDCS will significantly increase functional connectivity within the working memory network during active tDCS but not sham.

The present study will provide insight into mechanisms underlying tDCS application in MCI population for combating cognitive decline in a rapidly aging population in the United States. Information gathered from this study may guide future intervention strategies to combat cognitive decline and improve the quality of life of aging population.

Conditions

Cognitive Impairment; Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Active tDCS

A neuroConn MR-safe 1x1 tDCS stimulator will be used to apply 12 minutes of 2.0 mA electrical current, with 30 seconds ramps up and 30 seconds ramps down. The electrical current will be applied by using two carbon rubber electrodes (one anode, one cathode) with added ten20 conductive paste. The electrode+paste will be affixed on the participant's scalp over the frontal cortices at F3 and F4 location (EEG 10-20 system). Inflow of current (anode) will occur at F4 location, and outflow of current will occur at F3 (cathode). For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group.

Group Type: EXPERIMENTAL

Active tDCS

Intervention Type: DEVICE

A neuroConn MR-safe 1x1 tDCS stimulator will be used to apply 12 minutes of 2.0 mA electrical current, with 30 seconds ramps up and 30 seconds ramps down. The electrical current will be applied by using two carbon rubber electrodes (one anode, one cathode) with added ten20 conductive paste. The electrode+paste will be affixed on the participant's scalp over the frontal cortices at F3 and F4 location (EEG 10-20 system). Inflow of current (anode) will occur at F4 location, and outflow of current will occur at F3 (cathode). For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group.

Sham tDCS

Sham stimulation will be performed with the same 1x1 device. Participants will receive 2 mA of direct current stimulation for 30 seconds with 30 seconds ramps up and down. This provides the tingling and prickling sensation on the scalp associated with tDCS while prevent delivering sufficient current (12 minutes) to penetrate the skull and stimulate the brain. Prep in sham conditions will be identical to active stimulation conditions. For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group.

Group Type: PLACEBO_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

Sham stimulation will be performed with the same 1x1 device. Participants will receive 2 mA of direct current stimulation for 30 seconds with 30 seconds ramps up and down. This provides the tingling and prickling sensation on the scalp associated with tDCS while prevent delivering sufficient current (12 minutes) to penetrate the skull and stimulate the brain. Prep in sham conditions will be identical to active stimulation conditions. For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group.

Interventions

Active tDCS

A neuroConn MR-safe 1x1 tDCS stimulator will be used to apply 12 minutes of 2.0 mA electrical current, with 30 seconds ramps up and 30 seconds ramps down. The electrical current will be applied by using two carbon rubber electrodes (one anode, one cathode) with added ten20 conductive paste. The electrode+paste will be affixed on the participant's scalp over the frontal cortices at F3 and F4 location (EEG 10-20 system). Inflow of current (anode) will occur at F4 location, and outflow of current will occur at F3 (cathode). For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group.

Intervention Type: DEVICE

Sham tDCS

Sham stimulation will be performed with the same 1x1 device. Participants will receive 2 mA of direct current stimulation for 30 seconds with 30 seconds ramps up and down. This provides the tingling and prickling sensation on the scalp associated with tDCS while prevent delivering sufficient current (12 minutes) to penetrate the skull and stimulate the brain. Prep in sham conditions will be identical to active stimulation conditions. For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 60-95 years
• Montreal Cognitive Assessment (MoCA) score 18 and above (scores will be adjusted for education)
• Able to receive electrical stimulation
• Adequate motor capacity to participate in intervention and training sessions

Exclusion Criteria

• Contraindications to MRI recording
• Left-handed
• Inability to communicate in English
• History of neurological/psychiatric disorders and traumatic brain injury
• Incidence of stroke
• Severe visual and hearing impairment precluding completion of study assessments

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aprinda I Queen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB202401208

Identifier Type: -

Identifier Source: org_study_id