Non-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia
NCT05661084, Not applicable, Recruiting, Hebrew SeniorLife
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Non-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia | ClinicalTrials.gov |
| NCT number | NCT05661084 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 144 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Hebrew SeniorLife | ClinicalTrials.gov |
| Conditions | Dementia, Memory Loss, Alzheimer Disease, Executive Dysfunction, Mobility Limitation | ClinicalTrials.gov |
| Interventions | Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active), Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham), Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham), Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (active) | ClinicalTrials.gov |
| First posted | 2022-12-22 | ClinicalTrials.gov |
| Last updated | 2026-01-12 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall | baseline, immediate post-intervention, 3 month follow up , 6 month follow up | This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time. Total recall is measured by the total number of words out of 15 the participant is able to recall. Scores range from 0 to 15. | ClinicalTrials.gov |
| Primary | Change in Dual Task Cost to Gait | baseline, immediate post-intervention, 3 month follow up, 6 month follow up | This measure is captured by Mobility Lab™ (APDM Inc) software while the participant is walking with sensors at a) normal speed (speed for single task) and b) walking while counting backwards by 3's or 1's (speed dual task). The formula for cost of the dual task to gait is: (speedsingletask-speeddualtask)/speedsingletask)\*100). Range for dual task cost is as follows: High Risk for falls \> 0.2, Moderate Risk for falls \<= 0.2, Low Risk \< 0.1. | ClinicalTrials.gov |
| Secondary | Change in Functional Activity Questionnaire | baseline, immediate post-intervention, 3 month follow up, 6 month follow up | This is a 10-item scale to measure functional status via independent activities of daily living. Each item is a functional activity, and the caregiver/informant rates the participant's ability using the following scoring system: * Dependent = 3 * Requires assistance = 2 * Has difficulty but does by self = 1 * Normal = 0 * Never did \[the activity\] but could do now = 0 * Never did and would have difficulty now = 1 The scores are summed (range 0-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. This test will be used to track functional status over the course of the intervention and follow-up. | ClinicalTrials.gov |
| Secondary | Change in Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores | baseline, immediate post-intervention, 3 month follow up, 6 month follow up | The Montreal Cognitive Assessment (MoCA) is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains. The total possible score is 30 points; a score of 26 or above is considered normal. Severity of impairment can be determined with the following scores: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment. The maximum total score is 30 and the minimum total score is 0 points. The memory and executive subscales are each on a range of 0 to 5 points. | ClinicalTrials.gov |
| Secondary | Average E-field normal component (En) for left angular gyrus and prefrontal cortex | immediate post-intervention | From magnetic resonance imaging, an E-field normal component value will be computer for each brain voxel. From those measurements an average En value will be computed in the anatomically-defined left AG (i.e., Brodmann areas 39/40), and separately the left PFC (i.e., Brodmann areas 39/40). This outcome of average En will provide information on the amount of current each participant receives during the intervention in the targeted areas. | ClinicalTrials.gov |
| Secondary | Change in Adjusted Trail Making Test performance | baseline, immediate post-intervention, 3 month follow up, 6 month follow up | The Trail Making Test (TMT) is a test of visual attention and task switching, which consists of two parts (A \& B). It is scored by timing how long it takes to complete each part of the test, separately. The maximum time allowed for part A or part B is 300 seconds. Age and education adjusted norms are available to determine standard scores. The Adjusted performance is calculated by subtracting the time it takes to complete part A (in seconds) from the time it takes (in seconds) to complete part B. This is a measure of executive functioning and also has age and education adjusted norms. | ClinicalTrials.gov |
| Secondary | Change in Stroop test response latency | baseline, immediate post-intervention, 3 month follow up, 6 month follow up | The Stroop test assess the participant's ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. The outcome of response latencies, specifically, measures the average reaction time (in milliseconds) of the participant to a) the congruent trials (colors match words) and b) the incongruent trials (colors do not match words). The average difference between congruent and incongruent response latencies will be examined. | ClinicalTrials.gov |
| Secondary | Change in Gait speed | baseline, immediate post-intervention, 3 month follow up, 6 month follow up | The speed of the participants gait during both a) normal walking and b) walking while counting backwards. The speed is measured by the software, Mobility Lab, which is gathered via sensor. Average gait speed varies by age and education. | ClinicalTrials.gov |
| Secondary | Change in Stride time variability | baseline, immediate post-intervention, 3 month follow up, 6 month follow up | This is measured by the software, Mobility Lab, which is gathered via sensor as the participant is walking. The average stride time varies by age and education and is the coefficient of variation of stride times during a normal walk on a straight path. | ClinicalTrials.gov |
| Secondary | Change in Short Physical Performance Battery total score | baseline, immediate post-intervention, 3 month follow up, 6 month follow up | This is an assessment of lower extremity function, and combines results of gait speed, chair stand and balance tests. The range of scores is from 0 to 12, with higher scores indicating better lower extremity functioning. | ClinicalTrials.gov |
| Secondary | Change in 12-item Short Form Health Survey (SF-12) | baseline, immediate post-intervention, 3 month follow up, 6 month follow up | The Short Form - 12 is a measure of health-related quality of life. There are 12 items with responses either from 1 to 3 or 1 to 5 on a Likert-type scale. Standardized scores are calculated for a physical component summary (PCS) and a mental component summary (PCS), with an average of 50 and a standard deviation of 10 and higher scores with better functioning. | ClinicalTrials.gov |
| Secondary | Change in Average daily step count | baseline, immediate post-intervention, 3 month follow up, 6 month follow up | An average daily step count will be computed from data collected through an activity monitor over a 7-day period. The average of the 7 days will be computed for an average daily step count. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01AG076708 | Multifocal transcranial current stimulation for cognitive and motor dysfunction in dementia | PASCUAL-LEONE, ALVARO; MANOR, BRADLEY D. | HEBREW REHABILITATION CENTER FOR AGED | NATIONAL INSTITUTE ON AGING | 2022 to 2024 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Verbal Learning | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)