Noninvasive Brain Stimulation on Memory in Individuals With Mild Cognitive Impairment and History of Brain Injury

NCT ID: NCT04504630

Last Updated: 2026-01-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-05

Study Completion Date

2025-01-30

Brief Summary

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The study will examine the efficacy of high definition transcranial direct current stimulation (HD-tDCS) and its influence on episodic memory in patients with amnestic mild cognitive impairment and a history of Traumatic brain injury. Ten sessions of HD-tDCS to the dorsal anterior cingulate region is expected to result in improvements in episodic memory measures immediately following the last session and at a 3-month follow-up.

Detailed Description

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Conditions

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Amnestic Mild Cognitive Impairment Traumatic Brain Injury Mild Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active HD-tDCS

Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.

Group Type ACTIVE_COMPARATOR

High Definition Transcranial Direct Current Stimulation

Intervention Type DEVICE

This wireless device delivers a very low electrical current to focused regions on the scalp in order to modulate underlying brain circuits to promote neuroplasticity. The device will be fitted onto a neoprene EEG cap, with 1 anode electrode placed and surrounded by 4 cathode electrodes in a ring pattern. Electrical stimulation will be applied using a constant voltage cortical stimulator (Model D185, Digitimer Ltd, UK, maximal output 1000 V/1.5 A) with single square-wave 50-μs pulses (0.1 A/μs rise time).

Sham HD-tDCS

Participants will receive 10 sessions of sham stimulation across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.

Group Type SHAM_COMPARATOR

Sham HD-tDCS

Intervention Type DEVICE

Sham HD-tDCS

Interventions

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High Definition Transcranial Direct Current Stimulation

This wireless device delivers a very low electrical current to focused regions on the scalp in order to modulate underlying brain circuits to promote neuroplasticity. The device will be fitted onto a neoprene EEG cap, with 1 anode electrode placed and surrounded by 4 cathode electrodes in a ring pattern. Electrical stimulation will be applied using a constant voltage cortical stimulator (Model D185, Digitimer Ltd, UK, maximal output 1000 V/1.5 A) with single square-wave 50-μs pulses (0.1 A/μs rise time).

Intervention Type DEVICE

Sham HD-tDCS

Sham HD-tDCS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 50 and older
* Native English speakers
* 12 years of education or higher
* Active diagnosis of aMCI
* History of TBI based on VA/DOD criteria

Exclusion Criteria

* TBI within the past 2 years
* Lifetime history of stroke, transient ischemic attack, heart attack, or congestive heart failure
* Lifetime history of epilepsy
* Major psychiatric disorders (i.e., posttraumatic stress disorder, bipolar disorder, schizophrenia)
* Substance use disorder
* Has metal fragments in head
* Taking medications that may interact with the HD-tDCS effect (i.e., amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, dextromethorphan, D-cycloserine, flunarizine, or ropinirole)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Congressionally Directed Medical Research Programs

FED

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Christian Lobue

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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CDMRP-AZ190088

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STU-2019-1769

Identifier Type: -

Identifier Source: org_study_id

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