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

• ClinicalTrials.gov Identifier: NCT04504630
• Recruitment Status: Recruiting
• First Posted: August 7, 2020
• Last Update Posted: January 13, 2023
• Sponsor: University of Texas Southwestern Medical Center
• Collaborator: U.S. Army Medical Research and Development Command
• Information provided by (Responsible Party): Christian Lobue, University of Texas Southwestern Medical Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Amnestic Mild Cognitive Impairment; Traumatic Brain Injury; Mild Traumatic Brain Injury	Device: High Definition Transcranial Direct Current Stimulation; Device: Sham HD-tDCS	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: High-Definition Transcranial Direct Current Stimulation on Episodic Memory in Individuals With Amnestic Mild Cognitive Impairment and History of TBI
• Actual Study Start Date: December 5, 2020
• Estimated Primary Completion Date: January 31, 2023
• Estimated Study Completion Date: August 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Device: 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).
Sham Comparator: 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.	Device: Sham HD-tDCS; Sham HD-tDCS

Outcome Measures

Primary Outcome Measures :

1. Mean change from baseline in episodic memory functioning immediately following the last HD-tDCS session and at 3-month follow-up [ Time Frame: Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up ]
   Episodic verbal memory will be assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R). This measures rate of learning for verbal material and the amount retained after a delay. Episodic visual memory will be assessed with the Brief Visuospatial Memory Test-Revised (BVMT-R). This measures rate of learning for visual material and the amount retained after a delay. Both measures provide standardized scores based on a normative sample adjusted for key demographic factors, with higher scores reflecting better performances.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United States, Texas

University of Texas Southwestern Medical Center; Recruiting

Dallas, Texas, United States, 75390

Contact: Christian B LoBue, PhD 214-648-7226 christian.lobue@utsw.edu

Contact: Nyaz Didehbani, PhD 214-648-7226 nyaz.didehbani@utsw.edu

Sponsors and Collaborators

University of Texas Southwestern Medical Center

U.S. Army Medical Research and Development Command

More Information

• Responsible Party: Christian Lobue, Assistant Professor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT04504630
• Other Study ID Numbers: STU-2019-1769
• First Posted: August 7, 2020
• Last Update Posted: January 13, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: There is a plan to upload study data to the FITBIR repository system within one year of completion.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries; Cognitive Dysfunction; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Head Injuries, Closed; Wounds, Nonpenetrating