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

Primary Purpose

Amnestic Mild Cognitive Impairment, Traumatic Brain Injury, Mild Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Definition Transcranial Direct Current Stimulation
Sham HD-tDCS
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amnestic Mild Cognitive Impairment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Texas Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active HD-tDCS

Sham HD-tDCS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean change from baseline in episodic memory functioning immediately following the last HD-tDCS session and 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.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2020
Last Updated
April 3, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT04504630
Brief Title
Noninvasive Brain Stimulation on Memory in Individuals With Mild Cognitive Impairment and History of Brain Injury
Official Title
High-Definition Transcranial Direct Current Stimulation on Episodic Memory in Individuals With Amnestic Mild Cognitive Impairment and History of TBI
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amnestic Mild Cognitive Impairment, Traumatic Brain Injury, Mild Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active HD-tDCS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham HD-tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High Definition Transcranial Direct Current Stimulation
Intervention Description
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
Intervention Name(s)
Sham HD-tDCS
Intervention Description
Sham HD-tDCS
Primary Outcome Measure Information:
Title
Mean change from baseline in episodic memory functioning immediately following the last HD-tDCS session and at 3-month follow-up
Description
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.
Time Frame
Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian B LoBue, PhD
Phone
214-648-7226
Email
christian.lobue@utsw.edu
First Name & Middle Initial & Last Name & Degree
Nyaz Didehbani, PhD
Phone
214-648-7226
Email
nyaz.didehbani@utsw.edu

12. IPD Sharing Statement

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

Learn more about this trial

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

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