DementiaNCT06192433
Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive Impairment
A study testing High-frequency repetitive transcranial magnetic stimulation (40Hz) and Moderately high-frequency repetitive transcranial magnetic stimulation (10Hz) in people with Dementia and Cognitive Impairment, Mild, run by Taipei Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
Trial summary
Introduction and Purpose: In recent years, non-pharmacological treatment methods for dementia patients have been gradually explored. Among these, Transcranial Magnetic Stimulation (TMS) has been proposed as a non-invasive treatment option. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Cognitive Impairment, Mild
- What is being tested?
- High-frequency repetitive transcranial magnetic stimulation (40Hz) and Moderately high-frequency repetitive transcranial magnetic stimulation (10Hz)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jul 2023to 19 Jun 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 and above.
- Have received at least 2 years of education.
- Diagnosed with dementia or Mild Cognitive Impairment (MCI).
- Clinical Dementia Rating (CDR) score of ≥0.5.
Who cannot join
- Mental illness.
- Alcohol or substance addiction.
- History of heart rhythm disorders.
- History of epilepsy.
- History of brain injury.
- Underwent neurosurgery.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, ROC, 24213
About this study
Official title: Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive
Introduction and Purpose:
In recent years, non-pharmacological treatment methods for dementia patients have been gradually explored. Among these, Transcranial Magnetic Stimulation (TMS) has been proposed as a non-invasive treatment option. However, the optimal frequency and stimulation site for repetitive transcranial magnetic stimulation have not been definitively determined.
Read more
Methods:
This study is a randomized controlled trial. We randomly assigned 30 patients with mild cognitive impairment or dementia to the high-frequency transcranial magnetic stimulation group (40 Hz rTMS) or the moderately high-frequency transcranial magnetic stimulation group (10 Hz rTMS). Stimulation was applied to the bilateral dorsolateral prefrontal cortex (DLPFC). Each patient received a course of treatment for 10 consecutive working days. The high-frequency group received pulses at 40 Hz with an intensity of 40% of the maximum intensity for 2 seconds followed by a 58-second rest period, per set. The moderately high-frequency group received pulses at 10 Hz with an intensity of 90% of the maximum intensity for 4 seconds followed by a 56-second rest period, per set. Each day, patients received 30 sets of stimulation (15 times on the left side and 15 times on the right side), totaling 2400 pulses. Cognitive assessments were conducted on patients before and after the treatment course. Quantitative analysis will be performed using the Statistical Package for the Social Sciences statistical software. The Kolmogorov-Smirnov test will be used to check if the data follows a normal distribution. The chi-squared test will compare differences in baseline categorical variables between the groups, while independent t-tests or the Mann-Whitney U Test will compare baseline differences in continuous variables to assess the effectiveness of random assignment. Analysis of variance (ANOVA) and post-hoc comparisons will be used to compare intergroup and intragroup differences. The significance level is set at α = 0.05.
- Conditions
- Dementia, Cognitive Impairment, Mild
- Being tested
- High-frequency repetitive transcranial magnetic stimulation (40Hz), Moderately high-frequency repetitive transcranial magnetic stimulation (10Hz)
- Keywords
- high-frequency transcranial magnetic stimulation, cognitive impairment, Dementia
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency repetitive transcranial magnetic stimulation (40Hz)Device
Participants in this group receive high-frequency TMS at 40 Hz. The TMS intervention is applied to the bilateral dorsolateral prefrontal cortex (DLPFC). Each patient undergoes this TMS treatment for a course of 10 consecutive working days. The specific parameters for TMS include pulses at 40 Hz with an intensity set at 40% of the maximum intensity. Each pulse lasts for 2 seconds, followed by a 58-second rest period. On each treatment day, patients receive 30 sets of stimulation, with 15 stimulations applied to the left side and 15 to the right side, totaling 2400 pulses.
Moderately high-frequency repetitive transcranial magnetic stimulation (10Hz)Device
Participants in this group receive moderately high-frequency TMS at 10 Hz. Similar to the high-frequency group, the TMS intervention targets the bilateral dorsolateral prefrontal cortex (DLPFC) and is administered for a course of 10 consecutive working days. The TMS parameters for this group involve pulses at 10 Hz with an intensity set at 90% of the maximum intensity. Each pulse lasts for 4 seconds, followed by a 56-second rest period. As in the high-frequency group, patients in this group also receive 30 sets of stimulation per treatment day, with 15 stimulations applied to the left side and 15 to the right side, totaling 2400 pulses.
| Study group | Role | What they receive |
|---|---|---|
| High-frequency repetitive transcranial magnetic stimulation group (40Hz) | Experimental | High-Frequency Group (40Hz): Participants in this arm receive high-frequency transcranial magnetic stimulation (rTMS) at 40Hz for a specified duration and intensity on the bilateral dorsolateral prefrontal cortex (DLPFC). The stimulation parameters and rest periods are outlined in the study description. Receives: Device: High-frequency repetitive transcranial magnetic stimulation (40Hz) |
| Moderately high-frequency repetitive transcranial magnetic stimulation group (10Hz) | Active comparator | Moderately High-Frequency Group (10Hz): Participants in this arm receive moderately high-frequency transcranial magnetic stimulation (TMS) at 10Hz for a specified duration and intensity on the bilateral dorsolateral prefrontal cortex (DLPFC). The stimulation parameters and rest periods are outlined in the study description. Receives: Device: Moderately high-frequency repetitive transcranial magnetic stimulation (10Hz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Dementia Rating (CDR)
The Clinical Dementia Rating is an assessment tool that primarily focuses on six domains: memory, orientation, judgment and problem-solving ability, community affairs, home and hobbies, and personal care. The questionnaire consists of two parts: the first part is answered by a caregiver and provides basic information about the individual (standard answers), while the second part is answered by the individual to compare against the answers from the first part. Each domain is scored from 0 to 3, with higher scores indicating more severe symptoms.
Measured: pre treatment / ten days later (post treatment)
Mini-Mental State Examination (MMSE)
The MMSE consists of seven major domains: orientation, attention, memory, language, verbal comprehension, ability to perform tasks, and constructional ability. The total score is 30 points, with a cutoff typically set at 24 points; a score of 23 or lower indicates cognitive impairment.
Measured: pre treatment / ten days later (post treatment)
Montreal Cognitive Assessment (MoCA):
The test consists of 30 points and takes 10 minutes for the individual to complete. The basics of this test include short-term memory, executive function, attention, focus, and more.
Measured: pre treatment / ten days later (post treatment)
N-Back Test
The N-Back task is a series of stimuli that requires participants to respond when the current stimulus matches one presented n times before. In this study, a 2-Back test is used, meaning participants are asked to respond when they detect a stimulus that matches the one presented 2 stimuli ago.
Measured: pre treatment / ten days later (post treatment)
Stroop Color Word Test (SWCT)
Also known as the Color-Word Conflict Test, it requires the individual to quickly read the color of the text (e.g., red, blue, green) rather than its meaning.
Measured: pre treatment / ten days later (post treatment)
Wisconsin Card Sorting Test (WCST)
The WCST involves using four stimulus cards and a reference card. Participants are not informed of the pairing rules (color, shape, number form) and must choose a stimulus card to match with a response card. The tester provides feedback as "correct" or "incorrect." When the participant correctly pairs 10 cards in a row using the same rule, the tester changes the pairing rule. This test assesses the individual's executive function.
Measured: pre treatment / ten days later (post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start26 Jul 2023
- Primary completion19 Apr 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Model description
- This study is a Randomized Controlled Trial designed to investigate the effects of different frequencies of transcranial magnetic stimulation (TMS) as non-pharmacological treatment for patients with mild cognitive impairment or dementia. The trial employs a Parallel Study Design, where two groups of participants are treated concurrently with either high-frequency transcranial magnetic stimulation (40 Hz rTMS) or moderately high-frequency transcranial magnetic stimulation (10 Hz rTMS).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Hospital, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192433
- Sponsor's protocol ID
- 202314
- Status last verified
- Nov 2024
- First submitted
- 13 Oct 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive
- ClinicalTrials.gov ID
- NCT06192433
- Acronym / sponsor ID
- 202314
- Conditions
- Dementia, Cognitive Impairment, Mild
- Keywords
- high-frequency transcranial magnetic stimulation, cognitive impairment, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Taipei Hospital, Ministry of Health and WelfareUniversity, hospital or other
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 5 Jan 2024 (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.
Introduction and Purpose:
In recent years, non-pharmacological treatment methods for dementia patients have been gradually explored. Among these, Transcranial Magnetic Stimulation (TMS) has been proposed as a non-invasive treatment option. However, the optimal frequency and stimulation site for repetitive transcranial magnetic stimulation have not been definitively determined.
Methods:
This study is a randomized controlled trial. We randomly assigned 30 patients with mild cognitive impairment or dementia to the high-frequency transcranial magnetic stimulation group (40 Hz rTMS) or the moderately high-frequency transcranial magnetic stimulation group (10 Hz rTMS). Stimulation was applied to the bilateral dorsolateral prefrontal cortex (DLPFC). Each patient received a course of treatment for 10 consecutive working days. The high-frequency group received pulses at 40 Hz with an intensity of 40% of the maximum intensity for 2 seconds followed by a 58-second rest period, per set. The moderately high-frequency group received pulses at 10 Hz with an intensity of 90% of the maximum intensity for 4 seconds followed by a 56-second rest period, per set. Each day, patients received 30 sets of stimulation (15 times on the left side and 15 times on the right side), totaling 2400 pulses. Cognitive assessments were conducted on patients before and after the treatment course. Quantitative analysis will be performed using the Statistical Package for the Social Sciences statistical software. The Kolmogorov-Smirnov test will be used to check if the data follows a normal distribution. The chi-squared test will compare differences in baseline categorical variables between the groups, while independent t-tests or the Mann-Whitney U Test will compare baseline differences in continuous variables to assess the effectiveness of random assignment. Analysis of variance (ANOVA) and post-hoc comparisons will be used to compare intergroup and intragroup differences. The significance level is set at α = 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a Randomized Controlled Trial designed to investigate the effects of different frequencies of transcranial magnetic stimulation (TMS) as non-pharmacological treatment for patients with mild cognitive impairment or dementia. The trial employs a Parallel Study Design, where two groups of participants are treated concurrently with either high-frequency transcranial magnetic stimulation (40 Hz rTMS) or moderately high-frequency transcranial magnetic stimulation (10 Hz rTMS).
| Arm | Type | Receives |
|---|---|---|
| High-frequency repetitive transcranial magnetic stimulation group (40Hz) | Experimental | Device: High-frequency repetitive transcranial magnetic stimulation (40Hz)High-Frequency Group (40Hz): Participants in this arm receive high-frequency transcranial magnetic stimulation (rTMS) at 40Hz for a specified duration and intensity on the bilateral dorsolateral prefrontal cortex (DLPFC). The stimulation parameters and rest periods are outlined in the study description. |
| Moderately high-frequency repetitive transcranial magnetic stimulation group (10Hz) | Active comparator | Device: Moderately high-frequency repetitive transcranial magnetic stimulation (10Hz)Moderately High-Frequency Group (10Hz): Participants in this arm receive moderately high-frequency transcranial magnetic stimulation (TMS) at 10Hz for a specified duration and intensity on the bilateral dorsolateral prefrontal cortex (DLPFC). The stimulation parameters and rest periods are outlined in the study description. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 60 and above.
- Have received at least 2 years of education.
- Diagnosed with dementia or Mild Cognitive Impairment (MCI).
- Clinical Dementia Rating (CDR) score of ≥0.5.
Key exclusion criteria (6 listed)
- Mental illness.
- Alcohol or substance addiction.
- History of heart rhythm disorders.
- History of epilepsy.
- History of brain injury.
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 |
|---|---|---|
| High-frequency repetitive transcranial magnetic stimulation (40Hz)Participants in this group receive high-frequency TMS at 40 Hz. The TMS intervention is applied to the bilateral dorsolateral prefrontal cortex (DLPFC). Each patient undergoes this TMS treatment for a course of 10 consecutive working days. The specific parameters for TMS include pulses at 40 Hz with an intensity set at 40% of the maximum intensity. Each pulse lasts for 2 seconds, followed by a 58-second rest period. On each treatment day, patients receive 30 sets of stimulation, with 15 stimulations applied to the left side and 15 to the right side, totaling 2400 pulses. | Device | High-frequency repetitive transcranial magnetic stimulation group (40Hz) |
| Moderately high-frequency repetitive transcranial magnetic stimulation (10Hz)Participants in this group receive moderately high-frequency TMS at 10 Hz. Similar to the high-frequency group, the TMS intervention targets the bilateral dorsolateral prefrontal cortex (DLPFC) and is administered for a course of 10 consecutive working days. The TMS parameters for this group involve pulses at 10 Hz with an intensity set at 90% of the maximum intensity. Each pulse lasts for 4 seconds, followed by a 56-second rest period. As in the high-frequency group, patients in this group also receive 30 sets of stimulation per treatment day, with 15 stimulations applied to the left side and 15 to the right side, totaling 2400 pulses. | Device | Moderately high-frequency repetitive transcranial magnetic stimulation group (10Hz) |
Primary outcome
Clinical Dementia Rating (CDR)
Time frame: pre treatment / ten days later (post treatment)
The Clinical Dementia Rating is an assessment tool that primarily focuses on six domains: memory, orientation, judgment and problem-solving ability, community affairs, home and hobbies, and personal care. The questionnaire consists of two parts: the first part is answered by a caregiver and provides basic information about the individual (standard answers), while the second part is answered by the individual to compare against the answers from the first part. Each domain is scored from 0 to 3, with higher scores indicating more severe symptoms.
Mini-Mental State Examination (MMSE)
Time frame: pre treatment / ten days later (post treatment)
The MMSE consists of seven major domains: orientation, attention, memory, language, verbal comprehension, ability to perform tasks, and constructional ability. The total score is 30 points, with a cutoff typically set at 24 points; a score of 23 or lower indicates cognitive impairment.
Montreal Cognitive Assessment (MoCA):
Time frame: pre treatment / ten days later (post treatment)
The test consists of 30 points and takes 10 minutes for the individual to complete. The basics of this test include short-term memory, executive function, attention, focus, and more.
N-Back Test
Time frame: pre treatment / ten days later (post treatment)
The N-Back task is a series of stimuli that requires participants to respond when the current stimulus matches one presented n times before. In this study, a 2-Back test is used, meaning participants are asked to respond when they detect a stimulus that matches the one presented 2 stimuli ago.
Stroop Color Word Test (SWCT)
Time frame: pre treatment / ten days later (post treatment)
Also known as the Color-Word Conflict Test, it requires the individual to quickly read the color of the text (e.g., red, blue, green) rather than its meaning.
Wisconsin Card Sorting Test (WCST)
Time frame: pre treatment / ten days later (post treatment)
The WCST involves using four stimulus cards and a reference card. Participants are not informed of the pairing rules (color, shape, number form) and must choose a stimulus card to match with a response card. The tester provides feedback as "correct" or "incorrect." When the participant correctly pairs 10 cards in a row using the same rule, the tester changes the pairing rule. This test assesses the individual's executive function.
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 21 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
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 High-frequency repetitive transcranial magnetic stimulation (40Hz) and Moderately high-frequency repetitive transcranial magnetic stimulation (10Hz) in people with Dementia and Cognitive Impairment, Mild, run by Taipei Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
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 4 inclusion and 6 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 21 Nov 2024. 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 Taiwan. 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. 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?
Clinical Dementia Rating (CDR) (time frame: pre treatment / ten days later (post treatment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.