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| Name | Class |
|---|---|
| Texas Alzheimer's Research and Care Consortium | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Active Treatment | Active Comparator | Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) 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 |
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| Phase 1: Sham Treatment | Sham Comparator | Participants will receive 10 sessions of sham stimulation 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 |
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| Phase 2: Active Treatment | Active Comparator | For Phase 2, participants randomized into the sham group will have the opportunity to return after 2 months from completing Phase 1. They will 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroElectric StarStim | Device | 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Rey Auditory Verbal Learning Test Score | 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 | Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test | 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 |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Active Treatment | Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks |
| FG001 | Phase 1: Sham Treatment | Participants will receive 10 sessions of sham stimulation 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 Sham Treatment: Sham stimulation for 10 sessions over 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Assigned to Treatment |
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| Started Treatment |
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| Follow-Up at 2 Months |
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| Phase 2: Started Open-label Treatment |
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| Phase 2: Follow-up at 2 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Active Treatment | Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Rey Auditory Verbal Learning Test Score | 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 | Posted | Mean | Standard Deviation | T-score on a scale | Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment |
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Adverse events were monitored from the start of assigned treatments (1 mA and sham) through study completion, up to 10 weeks. This involved collection of information about adverse effects daily at the beginning and end of each treatment session and then again at the 2-month follow-up visit. Participants who were assigned sham during Phase 1 and returned to receive active treatment during an open-label phase were monitored for adverse events following the same approach.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: Active Treatment | Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pneumonia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christian LoBue, PhD and Hsueh-Sheng Chiang, MD, PhD | UT Southwestern Medical Center | 2146484658 | Christian.LoBue@utsw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2025 | Apr 21, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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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.
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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.
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| Sham Treatment | Device | Sham stimulation for 10 sessions over 2 weeks |
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| Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment |
| Changes in Boston Naming Test Short Form | 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 | Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment |
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| BG001 | Phase 1: Sham Treatment | Participants will receive 10 sessions of sham stimulation 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 Sham Treatment: Sham stimulation for 10 sessions over 2 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Mean | Standard Deviation | years |
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Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks |
| OG001 | Phase 1: Sham Treatment | Participants will receive 10 sessions of sham stimulation 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 Sham Treatment: Sham stimulation for 10 sessions over 2 weeks |
| OG002 | Phase 2: Sham-to-Active Treatment | Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks |
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| Secondary | Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test | 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 | Posted | Mean | Standard Deviation | T-score on a scale | Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment |
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| Secondary | Changes in Boston Naming Test Short Form | 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 | Posted | Mean | Standard Deviation | T-score on a scale | Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment |
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| 0 |
| 12 |
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | Phase 1: Sham Treatment | Participants will receive 10 sessions of sham stimulation 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 Sham Treatment: Sham stimulation for 10 sessions over 2 weeks | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Phase 2: Sham-to-Active Open Label Treatment | Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks | 0 | 10 | 0 | 10 | 0 | 10 |
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| Symptomatic poor blood pressure | Cardiac disorders | Systematic Assessment | Unstable blood pressure |
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| Baseline Category Switching |
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| Immediate Post Letter Fluency |
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| Immediate Post Category Fluency |
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| Immediate Post Category Switching |
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| 2-Month Letter Fluency |
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| 2-Month Category Fluency |
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| 2-Month Category Switching |
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| 2-Month Follow-Up |
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