Clinical trial NCT05270408: Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia
Official title: Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Dementia
Keywords: Transcranial direct current stimulation
Alzheimer Disease
Mild Cognitive Impairment
Dementia
MCI
Mild neurocognitive disorder
Amnestic
Pre- alzheimer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 33
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 research objective of this study is to examine the efficacy of HD-tDCS to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be three treatment arms: two active HD-tDCS (1 mA or 2 mA) and a sham group. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up.

Detailed description: This is a pilot study being done to attempt to improve verbal episodic memory in persons with mild cognitive impairment (MCI) and dementia. Although the hippocampus is a brain structure most often associated with early deficits in MCI and dementia, the pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (DACC) have been shown to play a role in verbal episodic memory for such patients. The purpose of this study is to examine the efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI and dementia. Entraining the preSMA/DACC circuit with 10 sessions at one of two levels of HD-tDCS will allow the researchers to investigate whether neuromodulation may be used to improve verbal episodic memory. Participants will receive 10 sessions at one of two levels of active stimulation (1 mA or 2 mA anodal HD-tDCS targeting preSMA/DACC for 20 min) or sham across 2 weeks. The device is used to deliver high definition transcranial direct current stimulation to targeted regions. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up. The investigators plan to recruit English-speaking participants aged 50 years and older with MCI and dementia. Participants will be randomized into HD-tDCS conditions.

Eligibility criteria: Inclusion Criteria:

1. Age 50 and older
2. Fluent in English
3. Active diagnosis of MCI or dementia

Exclusion Criteria:

1. Substance use disorder
2. Has metal fragments in head
3. 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: Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Baseline, immediately following last treatment session, and 2-months post treatment
Secondary outcomes:
measure: Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R)
timeFrame: Baseline, immediately following last treatment session, and 2-months post treatment
measure: Change in Score on the Boston Naming Test Short Form
timeFrame: Baseline, immediately following last treatment session, and 2-months post treatment
measure: Change in Score on the Delis Kaplan Executive Function System (DKEFS) Phonemic Fluency
timeFrame: Baseline, immediately following last treatment session, and 2-months post treatment
measure: Change in Score on the Delis Kaplan Executive Function System (DKEFS) Semantic Fluency
timeFrame: Baseline, immediately following last treatment session, and 2-months post treatment
measure: Change in Score on the Trail Making Test
timeFrame: Baseline, immediately following last treatment session, and 2-months post treatment
measure: Change in Score on the Southwestern Assessment of Processing Speed
timeFrame: Baseline, immediately following last treatment session, and 2-months post treatment
measure: Change in Score on the DKEFS Color-Word Interference Test
timeFrame: Baseline, immediately following last treatment session, and 2-months post treatment
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Christian LoBue, PhD
role: PRINCIPAL_INVESTIGATOR
References: