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

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ClinicalTrials.gov Identifier: NCT04504630
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : December 10, 2020
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Christian Lobue, University of Texas Southwestern Medical Center

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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




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.



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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504630


Locations
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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
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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    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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