Repetitive Transcranial Magnetic StimulationNCT04754152
Long-term Effect of θ Burst Magnetic Stimulation on Clinical Symptoms of Alzheimer Disease
A study testing θ burst transcranial magnetic stimulation and Pharmacotherapy in people with Repetitive Transcranial Magnetic Stimulation, run by Anhui Medical University at 1 site in China.
Trial summary
This was a randomized, single-blind, parallel, placebo-controlled clinical trial assessing the efficacy of neuronavigational TBS among patients with AD. Fourty late-onset AD were included in the study, all the patients were divided into TBS groups and drug treatment group. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Repetitive Transcranial Magnetic Stimulation
- What is being tested?
- θ burst transcranial magnetic stimulation and Pharmacotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
- Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia
- CDR score ≤ 2
- Subject under treatment by IAChE for at least 3 Weeks.
- psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months
Who cannot join
- CDR > 2
- Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
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- History of head injury,stroke,or other neurologic disease.
- Organic brain defects on T1 or T2 images.
- History of seizures or unexplained loss of consciousness.
Show all 9Show fewer
- Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
- Family history of medication refractory epilepsy.
- History of substance abuse within the last 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui, 230022
About this study
This was a randomized, single-blind, parallel, placebo-controlled clinical trial assessing the efficacy of neuronavigational TBS among patients with AD. Fourty late-onset AD were included in the study, all the patients were divided into TBS groups and drug treatment group. Drug intervention group AD patients with drug regimen (donepezil 5mg / d) and primary care guidance, once every three months follow-up. TBS group is treated with TBS (a course of treatment every 3 months); after completing 4 treatments/follow-ups a year, evaluate the changes in MoCA, other clinical symptoms and multi-domain cognition tests, and brain Changes in structure and function.
- Being tested
- θ burst transcranial magnetic stimulation, Pharmacotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
θ burst transcranial magnetic stimulationOther
In addition to drug therapy, TBS supplementary therapy was given every 3 months.The TBS parameters were as follows: 3 pulses, 50 Hz bursts given every 200 ms (at 5 Hz), and an intensity of 70% of the resting motor threshold, as measured from the right first dorsal interosseous muscle using a handheld 70 mm figure-of-eight coil. Take a course every 10 weeks .
PharmacotherapyDrug
Stable doses of cholinesterase inhibitors were given and the patients were followed up every three months.
| Study group | Role | What they receive |
|---|---|---|
| TBS Group | Experimental | On the basis of drug treatment, a course of TBS treatment is performed every three months and 4 courses of treatment a year. Receives: Other: θ burst transcranial magnetic stimulation |
| Drug Group | Placebo comparator | Stable doses of cholinesterase inhibitors for the treatment and primary care guidance.Once every 3 months follow-up. Receives: Drug: Pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in Montreal Cognitive Assessment (MoCA)
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.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
Secondary outcomes (16)
The changes in MMSE(Mini Mental State Examination)
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.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
HAMD (Hamilton Depression Scale)
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.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
HAMA (Hamilton Anxiety Scale)
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.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
NPI (Neuropsychiatric Inventory)
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.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
ADL( Lawton-Brody Activities of Daily Living)
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.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
LMT (Logic Memory Test)
The changes in LMT will constitute the secondary research outcome.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
DST (Digital Span Test; Forward and Backward)
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.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
TMT (Trail Making Test)
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.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
JLOT(Judgment of line Judgment of line orientation test orientation test)
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.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
HVOT(Hooper visual organization test Hooper visual organization test)
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.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
The Stroop color test
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.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
MRI measures
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.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
Chinese version of the Auditory Verbal Learning Test (AVLT)
The changes in AVLT will constitute the secondary research outcome.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
Symbol Digit Modalities Test (SDMT)
The changes in SDMT will constitute the secondary research outcome.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
Verbal Fluency Test-letter and semantic (VFT-L/S).
The changes in VFT will constitute the secondary research outcome.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
Boston Naming Test (BNT)
The changes in BNT will constitute the secondary research outcome.
Measured: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start21 Apr 2021
- Primary completion17 May 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Repetitive Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754152
- Sponsor's protocol ID
- AHMU-AD-20210103
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu X, Yan Y, Hu P, Wang L, Wu Y, Wu P, Geng Z, Xiao G, Zhou S, Ji G, Qiu B, Wei L, Tian Y, Liu H, Wang K. Effects of a periodic intermittent theta burst stimulation in Alzheimer's disease. Gen Psychiatr. 2024 Jan 8;37(1):e101106. doi: 10.1136/gpsych-2023-101106. eCollection 2024.
PubMed 38274292
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effect of θ Burst Magnetic Stimulation on Clinical Symptoms of Alzheimer Disease
- ClinicalTrials.gov ID
- NCT04754152
- Acronym / sponsor ID
- AHMU-AD-20210103
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomized, single-blind, parallel, placebo-controlled clinical trial assessing the efficacy of neuronavigational TBS among patients with AD. Fourty late-onset AD were included in the study, all the patients were divided into TBS groups and drug treatment group. Drug intervention group AD patients with drug regimen (donepezil 5mg / d) and primary care guidance, once every three months follow-up. TBS group is treated with TBS (a course of treatment every 3 months); after completing 4 treatments/follow-ups a year, evaluate the changes in MoCA, other clinical symptoms and multi-domain cognition tests, and brain Changes in structure and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBS Group | Experimental | Other: θ burst transcranial magnetic stimulationOn the basis of drug treatment, a course of TBS treatment is performed every three months and 4 courses of treatment a year. |
| Drug Group | Placebo comparator | Drug: PharmacotherapyStable doses of cholinesterase inhibitors for the treatment and primary care guidance.Once every 3 months follow-up. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
- Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia
- CDR score ≤ 2
- Subject under treatment by IAChE for at least 3 Weeks.
- psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months
Key exclusion criteria (9 listed)
- CDR > 2
- Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
- History of head injury,stroke,or other neurologic disease.
- Organic brain defects on T1 or T2 images.
- History of seizures or unexplained loss of consciousness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| θ burst transcranial magnetic stimulationIn addition to drug therapy, TBS supplementary therapy was given every 3 months.The TBS parameters were as follows: 3 pulses, 50 Hz bursts given every 200 ms (at 5 Hz), and an intensity of 70% of the resting motor threshold, as measured from the right first dorsal interosseous muscle using a handheld 70 mm figure-of-eight coil. Take a course every 10 weeks . | Other | TBS Group |
| PharmacotherapyStable doses of cholinesterase inhibitors were given and the patients were followed up every three months. | Drug | Drug Group |
Primary outcome
changes in Montreal Cognitive Assessment (MoCA)
Time frame: 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.
16 secondary outcomes
The changes in MMSE(Mini Mental State Examination)
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
HAMD (Hamilton Depression Scale)
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
HAMA (Hamilton Anxiety Scale)
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
NPI (Neuropsychiatric Inventory)
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
ADL( Lawton-Brody Activities of Daily Living)
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
LMT (Logic Memory Test)
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
DST (Digital Span Test; Forward and Backward)
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
TMT (Trail Making Test)
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
JLOT(Judgment of line Judgment of line orientation test orientation test)
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
HVOT(Hooper visual organization test Hooper visual organization test)
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
The Stroop color test
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
MRI measures
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
Chinese version of the Auditory Verbal Learning Test (AVLT)
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
Symbol Digit Modalities Test (SDMT)
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
Verbal Fluency Test-letter and semantic (VFT-L/S).
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
Boston Naming Test (BNT)
Time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 38274292Wu X, Yan Y, Hu P, Wang L, Wu Y, Wu P, Geng Z, Xiao G, Zhou S, Ji G, Qiu B, Wei L, Tian Y, Liu H, Wang K. Effects of a periodic intermittent theta burst stimulation in Alzheimer's disease. Gen Psychiatr. 2024 Jan 8;37(1):e101106. doi: 10.1136/gpsych-2023-101106. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing θ burst transcranial magnetic stimulation and Pharmacotherapy in people with Repetitive Transcranial Magnetic Stimulation, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in Montreal Cognitive Assessment (MoCA) (time frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.