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Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History (PATH)

Primary Purpose

Mild Cognitive Impairment, Amnestic Mild Cognitive Disorder, Amnestic Mild Cognitive Impairment

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
High Definition Transcranial Direct Current Stimulation
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mild Cognitive Impairment focused on measuring MCI, TBI, memory, biomarker, Alzheimer

Eligibility Criteria

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

Inclusion Criteria:

  1. Active diagnosis of amnestic mild cognitive impairment
  2. Presence of an mTBI history for the mTBI+ group; absence of an mTBI history for a control sample
  3. Female and male subjects
  4. All races/ethnicities
  5. Age 55 years and older
  6. Fluent in English

Exclusion Criteria:

  1. Mild traumatic brain injury within past year
  2. Lifetime history of moderate or severe brain injury
  3. Lifetime major neurologic syndromes (e.g., stroke, epilepsy, brain tumor)
  4. Lifetime major cardiovascular conditions (e.g., heart attack, heart failure)
  5. Current substance use disorder
  6. Current major psychiatric disorders (e.g., major depressive disorder, bipolar disorder)
  7. Current vision or hearing impairment that interferes with testing
  8. Any electronic and or metallic implants in the skull or brain
  9. Current medication use known to alter HD-tDCS reactivity

Sites / Locations

  • University of Texas Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Active left frontal HD-tDCS

Active left temporal HD-tDCS

Sham HD=tDCS

Arm Description

Electrodes will be placed in a 4x1 ring configuration over the left frontal region in accordance with the International 10-10 EEG system. Stimulation will consist of a ramp up period in which the electrical current is gradually increased, 30 minutes of stimulation at 2 mA, and a ramp down period during which the electrical current is gradually removed. Stimulation will be applied back-to-back over three consecutive days.

Electrodes will be placed in a 4x1 ring configuration over the left temporal region in accordance with the International 10-10 EEG system. Stimulation will consist of a ramp up period in which the electrical current is gradually increased, 30 minutes of stimulation at 2 mA, and a ramp down period during which the electrical current is gradually removed. Stimulation will be applied back-to-back over three consecutive days.

Electrodes will be placed in the same 4x1 ring configuration over the left frontal region as the active left frontal condition to ensure a useful control condition. Stimulation will consist of a 30-second ramp up period until reaching 2 mA, followed immediately by a 30-second ramp down, and off for 29 minutes. The same ramp up and down process will be repeated in the final minute of the session to help preserve masking of conditions. Sham stimulation will be applied back-to-back over three consecutive days.

Outcomes

Primary Outcome Measures

Changes in Rey Auditory Verbal Learning Test Score
The RAVLT is a verbal episodic memory test that is sensitive to mesial and lateral verbal episodic memory circuit dysfunction. The primary outcome measure for this task is the total number of items immediately recalled during the learning trials and after the 20 minute delayed recall trial. Changes in scores from baseline to testing immediately following the completion of each condition will be examined.

Secondary Outcome Measures

Changes in Delis Kaplan Executive Function System (DKEFS) Trail Making Test
The DKEFS Trail Making Test is a measure of cognitive flexibility and executive functions. The task requires the subject to as quickly as possible complete five conditions, involving number cancellation, number sequencing, letter sequencing, number-letter switching, and line tracing. The outcome measure for this task is the time to complete each of the five conditions. Changes in scores from baseline to testing immediately following the completion of each condition will be examined.
Changes in Delis Kaplan Executive Function System (DKEFS) Color-Word Interference Test
The DKEFS Color-Word Interference test is a measure of information processing speed and complex attention. The task requires the subject to as quickly as possible complete four conditions, involving color naming, word reading, response inhibition, and then switching back-and-forth between two response patterns. The outcome measure for this task is the time to complete each of the four conditions. Changes in scores from baseline to testing immediately following the completion of each condition will be examined.

Full Information

First Posted
June 28, 2022
Last Updated
May 5, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05446584
Brief Title
Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History
Acronym
PATH
Official Title
Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
May 1, 2027 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will probe if the biological changes in amnestic mild cognitive impairment (aMCI) are related to a history of mild traumatic brain injury (mTBI) using high definition transcranial direct current stimulation (HD-tDCS) and blood-derived biomarker tools. Participants who Do as well as those who Do Not have a history of mTBI will be enrolled in the study.
Detailed Description
Ten study visits will be completed by each participant. The initial visit will include a blood draw and a baseline memory evaluation. Afterwards, participants will be randomized to begin with one of 3 conditions of HD-tDCS. The three conditions are sham-control, active stimulation to left frontal region, and active stimulation to left temporal region. All participants will be expected to completed each HD-tDCS condition, which will be counterbalanced and separated by 14 days. Active HD-tDCS will be applied at 2 mA for 30 minutes over 3 consecutive daily sessions while sham stimulation will be applied for the same duration and timespan. All subjects will complete memory assessments again immediately following each HD-tDCS condition for a total of four test sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Amnestic Mild Cognitive Disorder, Amnestic Mild Cognitive Impairment, Mild Traumatic Brain Injury, Concussion, Brain
Keywords
MCI, TBI, memory, biomarker, Alzheimer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
All subjects will complete 3 conditions of HD-tDCS. Each HD-tDCS condition is comprised of 3 days of active or sham stimulation targeting the left frontal and temporal lobes (i.e., within-subjects design), randomized by order, and separated by 14 days to avoid carry-over effects.
Masking
ParticipantOutcomes Assessor
Masking Description
The subjects will be informed that sham and active HD-tDCS will be used in the study, but they will be masked to condition. Aside from the PI, other study team members who perform assessments will be masked to HD-tDCS condition.
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active left frontal HD-tDCS
Arm Type
Active Comparator
Arm Description
Electrodes will be placed in a 4x1 ring configuration over the left frontal region in accordance with the International 10-10 EEG system. Stimulation will consist of a ramp up period in which the electrical current is gradually increased, 30 minutes of stimulation at 2 mA, and a ramp down period during which the electrical current is gradually removed. Stimulation will be applied back-to-back over three consecutive days.
Arm Title
Active left temporal HD-tDCS
Arm Type
Active Comparator
Arm Description
Electrodes will be placed in a 4x1 ring configuration over the left temporal region in accordance with the International 10-10 EEG system. Stimulation will consist of a ramp up period in which the electrical current is gradually increased, 30 minutes of stimulation at 2 mA, and a ramp down period during which the electrical current is gradually removed. Stimulation will be applied back-to-back over three consecutive days.
Arm Title
Sham HD=tDCS
Arm Type
Sham Comparator
Arm Description
Electrodes will be placed in the same 4x1 ring configuration over the left frontal region as the active left frontal condition to ensure a useful control condition. Stimulation will consist of a 30-second ramp up period until reaching 2 mA, followed immediately by a 30-second ramp down, and off for 29 minutes. The same ramp up and down process will be repeated in the final minute of the session to help preserve masking of conditions. Sham stimulation will be applied back-to-back over three consecutive days.
Intervention Type
Device
Intervention Name(s)
High Definition Transcranial Direct Current Stimulation
Intervention Description
HD-tDCS for this study is not intended to be a treatment, and will be applied continuously for 30 minutes at sham (0 mA) or 2 mA for active conditions across 3 consecutive daily sessions to probe neural circuit integrity. This specific HD-tDCS device is completely computer driven, running on a laptop using specialized software. Circular electrodes (12-mm in diameter) filled with conductive gel will be placed in a 4x1 ring configuration with the central electrode being the anode surrounded by four cathodes.
Primary Outcome Measure Information:
Title
Changes in Rey Auditory Verbal Learning Test Score
Description
The RAVLT is a verbal episodic memory test that is sensitive to mesial and lateral verbal episodic memory circuit dysfunction. The primary outcome measure for this task is the total number of items immediately recalled during the learning trials and after the 20 minute delayed recall trial. Changes in scores from baseline to testing immediately following the completion of each condition will be examined.
Time Frame
Baseline and immediately after completion of each HD-tDCS condition
Secondary Outcome Measure Information:
Title
Changes in Delis Kaplan Executive Function System (DKEFS) Trail Making Test
Description
The DKEFS Trail Making Test is a measure of cognitive flexibility and executive functions. The task requires the subject to as quickly as possible complete five conditions, involving number cancellation, number sequencing, letter sequencing, number-letter switching, and line tracing. The outcome measure for this task is the time to complete each of the five conditions. Changes in scores from baseline to testing immediately following the completion of each condition will be examined.
Time Frame
Baseline and immediately after completion of each HD-tDCS condition
Title
Changes in Delis Kaplan Executive Function System (DKEFS) Color-Word Interference Test
Description
The DKEFS Color-Word Interference test is a measure of information processing speed and complex attention. The task requires the subject to as quickly as possible complete four conditions, involving color naming, word reading, response inhibition, and then switching back-and-forth between two response patterns. The outcome measure for this task is the time to complete each of the four conditions. Changes in scores from baseline to testing immediately following the completion of each condition will be examined.
Time Frame
Baseline and immediately after completion of each HD-tDCS condition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active diagnosis of amnestic mild cognitive impairment Presence of an mTBI history for the mTBI+ group; absence of an mTBI history for a control sample Female and male subjects All races/ethnicities Age 55 years and older Fluent in English Exclusion Criteria: Mild traumatic brain injury within past year Lifetime history of moderate or severe brain injury Lifetime major neurologic syndromes (e.g., stroke, epilepsy, brain tumor) Lifetime major cardiovascular conditions (e.g., heart attack, heart failure) Current substance use disorder Current major psychiatric disorders (e.g., major depressive disorder, bipolar disorder) Current vision or hearing impairment that interferes with testing Any electronic and or metallic implants in the skull or brain Current medication use known to alter HD-tDCS reactivity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Neaves, MCRC
Phone
214-865-9508
Email
Stephanie.Neaves@utsw.edu
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
Email
christian.lobue@utsw.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Neaves, MCRC
Phone
214-865-9508
Email
Stephanie.Neaves@utsw.edu

12. IPD Sharing Statement

Learn more about this trial

Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History

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