Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History

Mild Cognitive Impairment Clinical Trial

— PATH  

Official title:

Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05446584
• Other study ID #: STU-2022-0591
• Status: Recruiting
• Phase: Phase 2
• Start date: April 20, 2023
• Est. completion date: May 31, 2027

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Hannah Cabrera, MCRC
• Phone: 214-865-9508
• Email: Hannah.Cabrera[@]utsw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: May 31, 2027
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amnestic Mild Cognitive Impairment
• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Cognition Disorders
• Cognitive Dysfunction
• Concussion, Brain
• Mild Cognitive Impairment
• Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• High Definition Transcranial Direct Current Stimulation
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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and immediately after completion of each HD-tDCS condition
Secondary	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.	Baseline and immediately after completion of each HD-tDCS condition
Secondary	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.	Baseline and immediately after completion of each HD-tDCS condition