Clinical trial NCT04504630: 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
Overall status: COMPLETED
Phase: NA
Conditions: Amnestic Mild Cognitive Impairment
Traumatic Brain Injury
Mild Traumatic Brain Injury
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2020-08-07
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Hopkins Verbal Learning Test-Revised Total Learning
timeFrame: Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up
measure: Hopkins Verbal Learning Test-Revised Delayed Recall
timeFrame: Baseline, immediately following the last HD-tDCS session, and a 3-month follow-up
measure: Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning
timeFrame: Baseline, immediately post-treatment, and a 3 -month follow-up
measure: Brief Visuospatial Memory Test-Revised Delayed Recall
timeFrame: Baseline, immediately post-treatment, and a 3-month follow-up
Secondary outcomes:
measure: Phonemic Fluency
timeFrame: Baseline, immediately post-treatment, and a 3-month follow-up
measure: Semantic Fluency
timeFrame: Baseline, immediate post-treatment, and a 3-month follow-up
measure: Trail Making Test
timeFrame: Baseline, immediate post-treatment, and a 3-month follow-up
measure: Stroop Color and Word Test
timeFrame: Baseline, immediate post-treatment, and a 3-month follow-up
measure: Digit Span Test
timeFrame: Baseline, immediate post-treatment, and a 3-month follow-up
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References: