Applying Non-invasive Brain Stimulation in Alzheimer's Rehabilitation
NCT04866979, Not applicable, Unknown, Università degli Studi di Trento
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Applying Non-invasive Brain Stimulation in Alzheimer's Rehabilitation | ClinicalTrials.gov |
| NCT number | NCT04866979 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Università degli Studi di Trento | ClinicalTrials.gov |
| Conditions | Alzheimer Disease, Mild Cognitive Impairment | ClinicalTrials.gov |
| Interventions | Experimental: Continuous TBS (cTBS), Intermittent TBS (iTBS), Cognitive training (CT)., Sham Stimulation (shamTBS) | ClinicalTrials.gov |
| First posted | 2021-04-30 | ClinicalTrials.gov |
| Last updated | 2023-05-10 | ClinicalTrials.gov |
Registered outcomes 22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Face-name associative memory performance - Measure of Memory Recall | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean change in performance in ability to correctly memorize face/name paired associations \[score range min=7, max=n/a, higher score=better outcome\]. Patients will start at level 7, the level at which the training software begins paired face/name associations. The software will not allow the patient to go below level 7, so this is the minimum score (level) threshold for all patients. | ClinicalTrials.gov |
| Primary | Mini-Mental State Evaluation (MMSE) Score - Non-Trained Measure of Global Function | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Neuropsychological evaluation using mean changes in the Mini-Mental State Evaluation(MMSE) score Score range is from 0-30, with a score of 25 or higher is classed as "normal". If the score is below 25, the result indicates a possible cognitive impairment. A lower score = worse outcome | ClinicalTrials.gov |
| Secondary | TMS evoked potentials - TEP: Analysis of cortical excitability and inhibition changes induced in the state of excitability/inhibition of brain circuits following the TMS impulse. | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | 120 pulses will be delivered to the target area (right DLPFC or left DLPFC) at 110% resting motor threshold intensity during EEG registration. This outcome will analyze cortical excitability and inhibition changes induced in the state of excitability/inhibition of brain circuits following the TMS impulse. The amplitude will be used as a marker of cortical excitability. | ClinicalTrials.gov |
| Secondary | Connectivity Index - Connectivity evoked by TMS: cortico-cortical connectivity analysis | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | 120 pulses will be delivered to the target area (right DLPFC or left DLPFC) at 110% resting motor threshold intensity during EEG registration. This outcome will analyze changes in the latencies and topographical distribution of the TEPs thus providing a connectivity index. This connectivity index will be used to infer the propagation of the activity from the stimulation site to functionally connected areas. | ClinicalTrials.gov |
| Secondary | TMS evoked oscillations: changes induced by TMS and its influence on intrinsic oscillatory activity | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | 120 pulses will be delivered to the target area (right DLPFC or left DLPFC) at 110% resting motor threshold intensity during EEG registration. This outcome will analyze changes in responses induced by TMS in the frequency domain for the intrinsic capacity of the stimulated area to generate oscillatory activity in specific frequency bands. | ClinicalTrials.gov |
| Secondary | Raven's Colored Progressive Matrices: Evaluation of abstract non-verbal reasoning | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes in test scores \[score range 0-36, higher score=better outcome\]) | ClinicalTrials.gov |
| Secondary | Digit Span: Evaluation of short and long term memory (verbal) | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes in test scores \[score range 0-9, higher score=better outcome\] | ClinicalTrials.gov |
| Secondary | Spatial Span: Evaluation of short and long term memory (visuospatial) | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes in test scores \[score range 0-10, higher score=better outcome\] | ClinicalTrials.gov |
| Secondary | Prose Memory:Evaluation of short and long term memory | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes in test scores \[score range 0-28, higher score=better outcome\]; | ClinicalTrials.gov |
| Secondary | Free And Cued Selective Reminding Test: Evaluation of short and long term memory | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes on tests scores \[Immediate: score range 0-36; Deferred: score range 0-12, higher score=better outcome\] | ClinicalTrials.gov |
| Secondary | Deferred re-enactment of the Complex Figure by Rey Osterrieth: Long term memory evaluation | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes on tests scores \[score range 0-36, higher score=better outcome\] | ClinicalTrials.gov |
| Secondary | Token Test: Evaluation of linguistic production | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes on tests scores \[score range 0-36, higher score = better outcome\] | ClinicalTrials.gov |
| Secondary | Semantic fluency and Phonemic fluency | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes on tests scores: \[score range 0-no limits, higher score=better outcome\] | ClinicalTrials.gov |
| Secondary | Multiple Features Cancellation task: Evaluation of attention and executive function "MFCT" | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes in scores on MFCT Time \[score range, min= N/A, max= no limit, higher score=worse outcome; Mean changes in scores on MFCT Accuracy \[score range min=0, max=20, higher score=better outcome\]; Mean changes in scores on MFCT False alarm \[score range min: N/A, max= no limit, high score=worse outcome\] | ClinicalTrials.gov |
| Secondary | Trail Making test (for A, B and B-A conditions): Evaluation of attention and executive function | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes on scores for each condition \[score range: min= n/a, max= no limits, higher score=worse outcome\] | ClinicalTrials.gov |
| Secondary | Stroop test Error and Time: Evaluation of attention and executive function | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes on scores \[score ranges min=N/A, max= no limit, higher score=worse outcome\] | ClinicalTrials.gov |
| Secondary | Attentional Matrices: Evaluation of attention and executive function | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes on scores \[score range 0-60, higher score=better outcome\] | ClinicalTrials.gov |
| Secondary | Copy of Rey's Complex Figure: Evaluation of practical and visual-constructive skills | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes on scores \[score range 0-36, higher score=better outcome\] | ClinicalTrials.gov |
| Secondary | Geriatric Depression Scale, GDS:Evaluation of depressive symptoms in the elderly | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes on scores \[score range 0-30, higher score=worse outcome\] | ClinicalTrials.gov |
| Secondary | Questionnaire of Identification of Deficits (QID): Evaluation on quality of life and identification of deficit questionnaire for the patient and caregiver | Prior to treatment (baseline=t0=week 1), at the end of the intensive treatment phase (t1=Week 4), at the end of the maintenance phase (t2=Week 8), 3 months post-treatment (t3=Week 12), & 5 months post treatment (t4=Week 20) | Mean changes on scores \[score range 0-52, higher score=worse outcome\] | 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 34
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 12887040 | BACKGROUND | PubMed |
| 15078569 | BACKGROUND | PubMed |
| 15165553 | BACKGROUND | PubMed |
| 16009779 | BACKGROUND | PubMed |
| 16273404 | BACKGROUND | PubMed |
| 16287724 | BACKGROUND | PubMed |
| 16452642 | BACKGROUND | PubMed |
| 17188568 | BACKGROUND | PubMed |
| 18566003 | BACKGROUND | PubMed |
| 19520986 | BACKGROUND | PubMed |
| 19833552 | BACKGROUND | PubMed |
| 20574108 | BACKGROUND | PubMed |
| 21246222 | BACKGROUND | PubMed |
| 21346213 | BACKGROUND | PubMed |
| 21462081 | BACKGROUND | PubMed |
| 21488986 | BACKGROUND | PubMed |
| 21671144 | BACKGROUND | PubMed |
| 22114748 | BACKGROUND | PubMed |
| 22170878 | BACKGROUND | PubMed |
| 22395804 | BACKGROUND | PubMed |
Grants 0
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 |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 11
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 |
|---|---|---|
| Face-name Memory Task | Primary outcome | ConductCognition |
| Cancellation Test | Secondary outcome | ConductCognition |
| Category Fluency | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Matrix Reasoning | Secondary outcome | ConductCognition |
| Selective Reminding Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Token Commands Task | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | 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)