Cognitive Outcomes of Brain Stimulation As a Later-in-Life Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Changes in Rey Auditory Verbal Learning Test Score
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
This is a pilot study being done to attempt to improve episodic memory problems in persons with mild cognitive impairment (MCI) or dementia. The pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (dACC) have been shown to play a role in episodic memory and language retrieval. Prior studies have suggested that neurostimulation targeting this region can improve episodic memory and word recall. 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 word retrieval and other cognitive functions in patients with MCI or dementia. Entraining the preSMA/dACC circuit with 10 sessions of HD-tDCS will allow us to study whether neurostimulation may be an effective treatment.
Detailed Description
The research objective of this study is to examine the efficacy of HD-tDCS to the preSMa/DaCC region and its influence on word retrieval and other cognitive functions in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be two treatment arms: active HD-tDCS (1 mA) and a sham group. For Phase 1, participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) or sham across 2 weeks. Word retrieval and other cognitive tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up. For Phase 2, participants randomized into the sham group will have the opportunity to return after 2 months and receive the active treatment while being unblinded to their treatment condition. Following 10 active treatment sessions, word retrieval and other cognitive tasks will again be completed immediately following the last HD-tDCS session and then a 2-month follow-up.
Investigators
Christian Lobue
ASSISTANT PROFESSOR - Psychiatry
University of Texas Southwestern Medical Center
Eligibility Criteria
Inclusion Criteria
- •Active diagnosis of mild cognitive impairment or dementia, Female and male subjects, All races/ethnicities, Age 55 years and older, Fluent in English,
Exclusion Criteria
- •Lifetime history of major neurologic syndromes (e.g., epilepsy, brain tumor, etc), Substance use disorder within the past year, Has metal fragments in skull/head, Current vision or hearing impairment that interferes with testing, Current medication use known to alter HD-tDCS reactivity
Outcomes
Primary Outcomes
Changes in Rey Auditory Verbal Learning Test Score
Time Frame: Pre-treatment, post-treatment (an average of 2 weeks), and 8 weeks post-treatment
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 the condition will be examined as well as from baseline to 8 months post-treatment. RAVLT : Rey Auditory Verbal Learning Test, 0-15 score for each trial, higher scores reflect better performance
Secondary Outcomes
- Changes in Boston Naming Test Short Form(Pre-treatment, post-treatment (an average of 2 weeks), and 8 weeks post-treatment)
- Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test(Pre-treatment, post-treatment (an average of 2 weeks), and 8 weeks post-treatment)