NCT06665022

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

Same day

First QC Date

October 28, 2024

Last Update Submit

November 18, 2024

Conditions

Cognitive ImpairmentCognitive Decline

Keywords

Cognitive AgingBrain Stimulationfunctional MRIComputational ModelingFinite Element Method (FEM)

Outcome Measures

Primary Outcomes (1)

  • 2-back Working Memory Accuracy

    The descriptive name of the scale is 2-back Working Memory Accuracy. Participants will perform in-scanner 0 and 2-back (i.e., N-back) working memory task that asks them to acknowledge whether a letter was the same as the letter 2 or N times before. Participant will view one letter at a time, with a crosshair appear briefly as an inter-stimulus interval. The task paradigm for each run consists of four blocks of 2-back and four blocks of 0-back. Two runs (before and during stimulation) will be performed at each visit.

    12 minutes versus 24 minutes in each session. Then comparing active versus sham stimulation sessions, separated by at least two weeks.

Study Arms (2)

Active tDCS

EXPERIMENTAL

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.

Device: Active tDCS

Sham tDCS

PLACEBO COMPARATOR

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.

Device: Sham tDCS

Interventions

Active tDCSDEVICE

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.

Active tDCS
Sham tDCSDEVICE

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.

Sham tDCS

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Aprinda I Queen, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
A blinding code will be entered into the stimulation device to initiate the randomized stimulation condition.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Participants will enroll in a randomized double-blinded crossover within subject study. Each participant will undergo two MRI sessions. Each MRI session will include either one active tDCS or one sham tDCS. The order of delivering active or sham tDCS first will be randomized. A washout period between active and sham tDCS will be set for at least two-weeks to ensure no after-effect from the first stimulation session will be carried over to the second session.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 30, 2024

Study Start

December 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 21, 2024

Record last verified: 2024-11

Locations

US(1)