Long-term Effect of θ Burst Magnetic Stimulation on Clinical Symptoms of Alzheimer Disease
NCT04754152, Not applicable, Completed, Anhui Medical University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Long-term Effect of θ Burst Magnetic Stimulation on Clinical Symptoms of Alzheimer Disease | ClinicalTrials.gov |
| NCT number | NCT04754152 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 45 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Anhui Medical University | ClinicalTrials.gov |
| Conditions | Repetitive Transcranial Magnetic Stimulation | ClinicalTrials.gov |
| Interventions | θ burst transcranial magnetic stimulation, Pharmacotherapy | ClinicalTrials.gov |
| First posted | 2021-02-15 | ClinicalTrials.gov |
| Last updated | 2023-02-28 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | changes in Montreal Cognitive Assessment (MoCA) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in MoCA will constitute assess response to rTMS the secondary research outcome measure used to.MoCA was developed by Nasreddine et al. based on clinical experience and reference to the MMSE cognitive items and scores, and the final version was finalized in November 2004. We adopted a localized version (Mandarin version#includes 2 alternative versions) in line with the Chinese cultural background.It includes 11 inspection items in 8 cognitive fields, including visual structure skills, executive function, naming, attention and calculation, language, abstract thinking, memory, and orientation. With a total score of 30 or more than 26, it is normal. Anyone who has been education for less than 12 years will need to add one point to his final score. The final score of the higher the better, and we hope the subjects' scores will improve after treatment. | ClinicalTrials.gov |
| Secondary | The changes in MMSE(Mini Mental State Examination) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in MMSE will constitute the secondary research outcome.The full name of MMSE is mini-mental state examination, and the scale consists of 30 subject, include the following seven aspects: time orientation, place orientation,immediate memory,attention and calculation,delay memory,language, visual space.One point is awarded for each question correctly answered during MMSE evaluation. If subject give the wrong answer or don't know answe he/ she awarded 0 score, scope of scale score of 0 to 30 points. The higher the score, the better. In this study, changes in MMSE scores before and after treatment were used as secondary observations,we hoped that scores would increase after treatment. | ClinicalTrials.gov |
| Secondary | HAMD (Hamilton Depression Scale) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in HAMD will constitute the secondary research outcome. Hamilton Depression Scale (HAMD) compiled by Hamilton in 1960, is the most common clinical to assess Depression Scale. In this study, 17 versions were selected, and there were 17 questions. The subjects were assessed for their depression in the past week. Each question scored between 0 and 4 points.Higher scores indicate more depressive symptoms. The severity of the disease and the therapeutic effect can be evaluated after treatment. In this study, we hoped that scores would decrease after treatment. | ClinicalTrials.gov |
| Secondary | HAMA (Hamilton Anxiety Scale) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in HAMA will constitute the secondary research outcome. Hamilton Anxiety Scale (HAMA) was compiled by Hamilton in 1959.It was one of the most commonly used scales in psychiatric clinic, including 14 items. It is often used in clinical diagnosis and degree classification of anxiety disorder. The subjects were assessed for their anxiety in the past week. Each question scored between 0 and 4 points. The higher the score, the more symptoms of anxiety. The severity of the disease and the therapeutic effect can be evaluated after treatment. In this study, we hoped that scores would decrease after treatment. | ClinicalTrials.gov |
| Secondary | NPI (Neuropsychiatric Inventory) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes NPI will constitute the secondary research outcome. The Neuropsychology Scale (NPI) evaluates 12 neuropsychiatric disorders which included 10 neuropsychiatric symptoms and 2 autonomic neurological symptoms based on the caregiver's perception of the patient's behavior and the perceived distress. Each item was evaluated for its occurrence frequency (1-4 points) and severity (1-3 points). The frequency and severity were multiplied to obtain the score (0-12 points) of each item.The patient's assessment rating ranges from 0 to 144, and the caregiver's distress rating score is 0 to 60. The lower the score, the lighter the symptoms, and we expect the score to go down after treatment. | ClinicalTrials.gov |
| Secondary | ADL( Lawton-Brody Activities of Daily Living) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes ADL will constitute the secondary research outcome. The ADL evaluates 20 items activities of daily living which included basic life ability and instrument use ability based on the caregiver's perception of the patient's behavior. Each item was evaluated for its severity (1-4 points). The patient's assessment rating ranges from 20 to 80, and the lower the score, the lighter the symptoms, and we expect the score to go down after treatment. | ClinicalTrials.gov |
| Secondary | LMT (Logic Memory Test) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in LMT will constitute the secondary research outcome. | ClinicalTrials.gov |
| Secondary | DST (Digital Span Test; Forward and Backward) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in DST will constitute the secondary research outcome. Digital span test (DST) was commonly used to evaluate attention ability and instantaneous memory ability. There are two types of test: forward(0-14) and backward(0-13).In the forward test, the subjects were asked to retell the the digits immediately after hearing it until they could not be repeated correctly.In backward test, the subjects were asked to repeat a set of numbers in reverse order until they could not be repeated correctly. The length of the last set of Numbers correctly repeated by the subjects was the final score, forward and backward are counted separately. The higher the score, the better. In this study, we hoped that scores would increase after treatment. | ClinicalTrials.gov |
| Secondary | TMT (Trail Making Test) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in TMT will constitute the secondary research outcome. The Trail Making Test (TMT) is divided into two parts, part A and part B. Part A requires the subject to connect 25 Numbers on the paper in sequence, and part B requires the subject to connect 25 Numbers of different colors alternately in sequence. The time it takes for the subject to complete all the Numbers is the subject's final score.In this study, we hoped that scores would decrease after treatment. | ClinicalTrials.gov |
| Secondary | JLOT(Judgment of line Judgment of line orientation test orientation test) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in JLOT (Judgment of line Judgment of line orientation test orientation test) will constitute assess response to rTMS the secondary research outcome measure.The JLOT test was determined by Benton et al. in 1994. There are two versions of H and V. The difference is that the order in which the pictures are presented is different. Each version contains 35 images, of which the official test consists of 30 images, and the other 5 images are for the participants to learn. The final score is the correct number of subjects to answer, the full score is 30 points, the higher the score, the better the space perception ability of the subject.We hope the subjects' scores will improve after treatment. | ClinicalTrials.gov |
| Secondary | HVOT(Hooper visual organization test Hooper visual organization test) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in HVOT(Hooper visual organization test Hooper visual organization test) will constitute assess response to rTMS the secondary research outcome measure.HVOT is a cognitive test used to evaluate the perceived structure of the subject. It consists of 30 items#and each question is 1 point and the total score is 30 points. The final score is the correct number of subjects to answer, the full score is 30 points, the higher the score, the better the space perception ability of the subject.We hope the subjects' scores will improve after treatment. | ClinicalTrials.gov |
| Secondary | The Stroop color test | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in The Stroop color test will constitute assess response to rTMS the secondary research outcome measure.The Stroop color word test was developed by Stroop in 1935 and is used to evaluate the attention function of the subject. The subject is required to correctly read the target color on the stimulus card and record the completion time. The final completion time is the score of the participant. The shorter the time used, the better the performance of the subjects. We expect the participants to spend less time after the real stimulation. | ClinicalTrials.gov |
| Secondary | MRI measures | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | Multimodal magnetic resonance data were acquired, including structural phase magnetic resonance and rest state magnetic resonance, to compare the neuroimaging differences between the true and sham stimulation groups before and after stimulation. | ClinicalTrials.gov |
| Secondary | Chinese version of the Auditory Verbal Learning Test (AVLT) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in AVLT will constitute the secondary research outcome. | ClinicalTrials.gov |
| Secondary | Symbol Digit Modalities Test (SDMT) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in SDMT will constitute the secondary research outcome. | ClinicalTrials.gov |
| Secondary | Verbal Fluency Test-letter and semantic (VFT-L/S). | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in VFT will constitute the secondary research outcome. | ClinicalTrials.gov |
| Secondary | Boston Naming Test (BNT) | baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up | The changes in BNT will constitute the secondary research 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 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 38274292 | DERIVED | 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 8
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 |
|---|---|---|
| Line Angle Matching | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | 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)