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

Traumatic Brain Injury Clinical Trial

Official title:

High-Definition Transcranial Direct Current Stimulation on Episodic Memory in Individuals With Amnestic Mild Cognitive Impairment and History of TBI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04504630
• Other study ID #: STU-2019-1769
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 5, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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 HD-tDCS
Sham HD-tDCS

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up