Amnestic Mild Cognitive Impairment - aMCI, Mild Cognitive Impairment
Conditions
Brief summary
This is a pilot study being done to attempt to improve episodic memory problems in persons with mild cognitive impairment (MCI). 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. 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 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.
Interventions
DEVICENeuroElectric StarStim
10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks
DEVICESham Treatment
Sham stimulation for 10 sessions over 2 weeks
Sponsors
University of Texas Southwestern Medical Center
Texas Alzheimer's Research and Care Consortium
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The subjects will be informed that sham and active HD-tDCS will be used in the study, but they will be masked to condition in Phase 1. Aside from the PI, other study team members who perform assessments will be masked to HD-tDCS condition. Questionnaires will be completed examining how well the participants and outcomes assessors were blinded in Phase 1. During Phase 2, individuals who were assigned to the sham condition will be unblinded following all assessments as they will be given the option to return for the active condition. Study team members will become unblinded as a result.
Intervention model description
In Phase 1, there will be two treatment arms (active and sham). All subjects will have the option to complete active stimulation of HD-tDCS. Those assigned to the sham condition group will have the option to return for active treatment in Phase 2. Each HD-tDCS condition is comprised of 10 days of active or sham stimulation targeting the pre-SMA (supplemental motor area)/sACC (subgenual anterior cingulate cortex) followed by neuropsychological testing after completion of the last session.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Active diagnosis of mild cognitive impairment, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Rey Auditory Verbal Learning Test Score | Pre-treatment, post-treatment (immediately following last HD-tDCS session), 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 30 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 weeks post-treatment. RAVLT : Rey Auditory Verbal Learning Test, 0-15 raw score for each trial (5 total trials) to be added altogether to generate a total learning score. Delayed recall trial has a raw score range of 0-15. Scores were transformed into T-scores using demographic based normative data, providing a score range from 0-100; with higher scores reflect better performance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test | Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment | The DKEFS Verbal Fluency Test is a measure of word retrieval. The task has 3 conditions each lasting 60 seconds, requiring the subject to name words by phonemes, semantic categories, and then switching between two semantic categories. The outcome measure for this task is the total words named for each of the 3 conditions. Changes in scores from baseline to testing immediately following the completion of each condition will be examined as well as from baseline to 8 weeks post-treatment. DKEFS: Delis-Kaplan Executive Function System Verbal Fluency Test, there are no specified limits for each trial, T-scores ranged from 20-80 across all 3 conditions; higher scores reflect better performance |
| Changes in Boston Naming Test Short Form | Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment | The Boston Naming Test Short Form has 30 pictures of common objects that upon seeing each picture, individuals need to name the object as soon as one can. The outcome measure for this task is the number of correctly named items. Changes in scores from baseline to testing immediately following the completion of condition will be examined as well as from baseline to 8 weeks post-treatment. BNT: Boston Naming Test - Short Form, 0-30 total raw score to be converted to a T-score, ranging from 20-80; higher scores reflect better performance |
Countries
United States
Participant flow
Pre-assignment details
Pre-assignment numbers refers to the number of people randomized into their arm after consenting but before starting intervention. This number could be different than the number enrolled and number started as some participants withdrew consent after the initial visit but before starting intervention. During this gap between consenting and withdrawal, they could have been randomized in anticipation of their intervention start timeframe.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 73.6 years STANDARD_DEVIATION 6.5 |
| Education | 16.3 years STANDARD_DEVIATION 2.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 2 / 12 | 0 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 10 |
Outcome results
None listed