Mild Cognitive ImpairmentNCT05327257
iTBS rTMS in Mild Cognitive Impairment
A study testing iTBS rTMS in people with Mild Cognitive Impairment, run by Maria I. Lapid, M.D. at 1 site in United States.
Trial summary
The purposes of this research are to test whether it is feasible to administer a treatment protocol called intermittent theta burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS) in adults with mild cognitive impairment (MCI), and to test whether iTBS rTMS treatments can improve memory in mild… Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- iTBS rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2022to 1 Dec 2025
- 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 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must speak English fluently
- Diagnosis of MCI as defined by:
- Clinical diagnosis by a neurologist
- Neuropsychological testing support of MCI
- Meet criteria for MCI
- Subjective cognitive decline reported by participant and/or an informant
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- Objective memory impairment in one or more cognitive domains for age
- Essentially preserved general cognitive function
- Largely intact functional activities
- Does not meet criteria for dementia as judged by a clinician
- Eligible for transcranial magnetic stimulation (TMS) based on safety criteria
- Clinical Dementia Rating=0.5
- Geriatric Depression Scale score less than 6
- Medically stable and in good general health
- Not pregnant, lactating, or of childbearing potential
- Stable medication regimen for at least 4 weeks prior to baseline visit
- Adequate visual and auditory abilities to complete neuropsychological testing
- Ability to provide informed consent
- Have a care partner who is available to accompany the participant to study visits for the duration of the protocol.
Who cannot join
- Inability to communicate in the English language
- Meet criteria for dementia
- Contraindications to TMS or MRI, including patients who have
- conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 30 cm of the treatment coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments or jewelry)
- active or inactive implants, including deep brain stimulators, cochlear implants, vagus nerve stimulators or implanted device leads
- Any true positive findings on the TMS safety screening form
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- Prior exposure to TMS, electroconvulsive therapy (ECT), or any neurostimulation within the past 12 months
- History of epilepsy or seizures
- Medical conditions that increase risk of seizures
- History of traumatic brain injury
- History of intracranial mass or lesion
- History of stroke, including hemorrhagic stroke and ischemic stroke
- Psychiatric disorders
- Primary psychotic disorder (schizophrenia, schizoaffective, or schizophreniform disorder), any history
- Primary mood disorder (major depressive disorder, bipolar disorder) within the past 12 months
- Substance use disorder (except caffeine and nicotine) within the past 12 months
- Active symptoms of depression, anxiety, mania, psychosis, or substance use (except caffeine and nicotine) within the past year
- Active symptoms of depression will be identified based on geriatric depression scale ≥ 6
- Other active symptoms of psychiatric conditions to be determined by study investigators
- Sleep disorders that are considered clinically significant and not sufficiently treated by the investigative team, including untreated obstructive sleep apnea (apnea-hypopnea index >15), untreated/suboptimally treated REM sleep behavior disorder, untreated/suboptimally treated restless legs syndrome
- Pregnancy or suspected pregnancy
- Participation in another concurrent interventional clinical trial
- Any unstable medical condition
- Inability to provide informed consent
- Inability to adhere to the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Feasibility and Pilot Randomized Controlled Double-blind Trial of Intermittent Theta Burst Stimulation (iTBS) Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Memory in Mild Cognitive Impairment (MCI)
The purposes of this research are to test whether it is feasible to administer a treatment protocol called intermittent theta burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS) in adults with mild cognitive impairment (MCI), and to test whether iTBS rTMS treatments can improve memory in mild cognitive impairment (MCI).
Read the detailed description
To test the feasibility of conducting a 10-day Intermittent Theta Burst Stimulation (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) protocol twice using a cross-over design in individuals with Mild Cognitive Impairment (MCI), pilot test the study protocol to assess study design, and collect pilot data on the effect of stimulations over 3 different brain regions (left dorsolateral prefrontal cortex (DLPFC), lateral parietal cortex (LPC), vertex) on working memory, new-learning and executive function in MCI. Neuropsychological and sleep measures, functional brain magnetic resonance imaging (fMRI), high density EEG and questionnaires will be performed at 5 timepoints - baseline, post-treatment after first period of 10 daily iTBS rTMS sessions, post-washout period of 4 weeks, post-treatment after cross-over to second period of 10 daily iTBS rTMS sessions, and 4 weeks follow-up post-treatment.
- Conditions
- Mild Cognitive Impairment
- Being tested
- iTBS rTMS
- Keywords
- Transcranial Magnetic Stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBS rTMSDevice
Repetitive transcranial magnetic stimulation (rTMS) intermittent Theta Burst Stimulation (iTBS)
| Study group | Role | What they receive |
|---|---|---|
| iTBS rTMS Left Dorsolateral Prefrontal Cortex (DLPFC) then Vertex | Experimental | Subjects will receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the DLPFC in the first treatment period, complete a washout period of 4 weeks then receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days. Receives: Device: iTBS rTMS |
| iTBS rTMS Lateral Parietal Cortex (LPC) then Vertex | Experimental | Subjects will receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the LPC in the first treatment period, complete a washout period of 4 weeks then receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days. Receives: Device: iTBS rTMS |
| iTBS rTMS Vertex then Left Dorsolateral Prefrontal Cortex (DLPFC) | Experimental | Subjects will receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days in the first treatment period, complete a washout period of 4 weeks then receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the DLPFC. Receives: Device: iTBS rTMS |
| iTBS rTMS Vertex then Lateral Parietal Cortex (LPC) | Experimental | Subjects will receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days in the first treatment period, complete a washout period of 4 weeks then receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the LPC. Receives: Device: iTBS rTMS |
| iTBS rTMS Vertex only | Sham comparator | Cognitively normal and healthy controls will receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days. The vertex serves as a control as there are no functional improvements in cognition with stimulation of the vertex region. Receives: Device: iTBS rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Referrals
Total number of participants referred to the study by clinicians
Measured: 16 weeks
Participant enrollment
Total number of participants enrolled in the study
Measured: 16 weeks
Treatment adherence
Total number of participants to comply with all study procedures as identified in the protocol
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start11 Aug 2022
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
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 Mild Cognitive ImpairmentStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria I. Lapid, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria I. Lapid, M.D., Mayo Clinic
- Investigators
- Maria I Lapid, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327257
- Sponsor's protocol ID
- 21-010661
- Status last verified
- Jan 2026
- First submitted
- 20 Mar 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lapid MI, Pagali SR, Basso MR, Croarkin PE, Geske JR, Huston J 3rd, Islam K, Joseph B, Kennebeck WW, Kang D, Kung S, LeMahieu AM, Lundstrom BN, Petersen RC, Sarran MM, Shu Y, Swanson IM, St Louis EK, Wang MK, Varatharajah Y, Wagh N, Welker KM, Worrell GA, Boeve BF. A pilot randomized controlled double-blind trial of intermittent theta burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS) to improve memory in mild cognitive impairment (MCI): a study protocol. Pilot Feasibility Stud. 2025 Apr 1;11(1):35. doi: 10.1186/s40814-025-01625-5.
PubMed 40170189
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Pilot Randomized Controlled Double-blind Trial of Intermittent Theta Burst Stimulation (iTBS) Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Memory in Mild Cognitive Impairment (MCI)
- ClinicalTrials.gov ID
- NCT05327257
- Acronym / sponsor ID
- 21-010661
- Conditions
- Mild Cognitive Impairment
- Keywords
- Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Maria I. Lapid, M.D.University, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 14 Apr 2022 (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.
The purposes of this research are to test whether it is feasible to administer a treatment protocol called intermittent theta burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS) in adults with mild cognitive impairment (MCI), and to test whether iTBS rTMS treatments can improve memory in mild cognitive impairment (MCI).
Detailed description
To test the feasibility of conducting a 10-day Intermittent Theta Burst Stimulation (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) protocol twice using a cross-over design in individuals with Mild Cognitive Impairment (MCI), pilot test the study protocol to assess study design, and collect pilot data on the effect of stimulations over 3 different brain regions (left dorsolateral prefrontal cortex (DLPFC), lateral parietal cortex (LPC), vertex) on working memory, new-learning and executive function in MCI. Neuropsychological and sleep measures, functional brain magnetic resonance imaging (fMRI), high density EEG and questionnaires will be performed at 5 timepoints - baseline, post-treatment after first period of 10 daily iTBS rTMS sessions, post-washout period of 4 weeks, post-treatment after cross-over to second period of 10 daily iTBS rTMS sessions, and 4 weeks follow-up post-treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| iTBS rTMS Left Dorsolateral Prefrontal Cortex (DLPFC) then Vertex | Experimental | Device: iTBS rTMSSubjects will receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the DLPFC in the first treatment period, complete a washout period of 4 weeks then receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days. |
| iTBS rTMS Lateral Parietal Cortex (LPC) then Vertex | Experimental | Device: iTBS rTMSSubjects will receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the LPC in the first treatment period, complete a washout period of 4 weeks then receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days. |
| iTBS rTMS Vertex then Left Dorsolateral Prefrontal Cortex (DLPFC) | Experimental | Device: iTBS rTMSSubjects will receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days in the first treatment period, complete a washout period of 4 weeks then receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the DLPFC. |
| iTBS rTMS Vertex then Lateral Parietal Cortex (LPC) | Experimental | Device: iTBS rTMSSubjects will receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days in the first treatment period, complete a washout period of 4 weeks then receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the LPC. |
| iTBS rTMS Vertex only | Sham comparator | Device: iTBS rTMSCognitively normal and healthy controls will receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days. The vertex serves as a control as there are no functional improvements in cognition with stimulation of the vertex region. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Must speak English fluently
- Diagnosis of MCI as defined by:
- Eligible for transcranial magnetic stimulation (TMS) based on safety criteria
- Clinical Dementia Rating=0.5
- Geriatric Depression Scale score less than 6
Key exclusion criteria (25 listed)
- Inability to communicate in the English language
- Meet criteria for dementia
- Contraindications to TMS or MRI, including patients who have
- Any true positive findings on the TMS safety screening form
- Prior exposure to TMS, electroconvulsive therapy (ECT), or any neurostimulation within the past 12 months
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 |
|---|---|---|
| iTBS rTMSRepetitive transcranial magnetic stimulation (rTMS) intermittent Theta Burst Stimulation (iTBS) | Device | iTBS rTMS Lateral Parietal Cortex (LPC) then Vertex, iTBS rTMS Left Dorsolateral Prefrontal Cortex (DLPFC) then Vertex, iTBS rTMS Vertex only, iTBS rTMS Vertex then Lateral Parietal Cortex (LPC), iTBS rTMS Vertex then Left Dorsolateral Prefrontal Cortex (DLPFC) |
Primary outcome
Clinician Referrals
Time frame: 16 weeks
Total number of participants referred to the study by clinicians
Participant enrollment
Time frame: 16 weeks
Total number of participants enrolled in the study
Treatment adherence
Time frame: 16 weeks
Total number of participants to comply with all study procedures as identified in the protocol
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 12 Jan 2026.
- Derived from this study: PubMed 40170189Lapid MI, Pagali SR, Basso MR, Croarkin PE, Geske JR, Huston J 3rd, Islam K, Joseph B, Kennebeck WW, Kang D, Kung S, LeMahieu AM, Lundstrom BN, Petersen RC, Sarran MM, Shu Y, Swanson IM, St Louis EK, Wang MK, Varatharajah Y, Wagh N, Welker KM, Worrell GA, Boeve BF. A pilot randomized controlled double-blind trial of intermittent theta burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS) to improve memory in mild cognitive impairment (MCI): a study protocol. Pilot Feasibility Stud. 2025 Apr 1;11(1):35. doi: 10.1186/s40814-025-01625-5.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Maria I Lapid principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS rTMS in people with Mild Cognitive Impairment, run by Maria I. Lapid, M.D. at 1 site in United States.
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 19 inclusion and 25 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 12 Jan 2026. 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 United States. 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?
Clinician Referrals (time frame: 16 weeks). The study lists 3 primary outcomes in all. 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 NCT05327257, 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 12 Jan 2026.