Alzheimer DiseaseNCT04771845
Transcranial Magnetic Stimulation in Mild Cognitive Impairment and Alzheimer Disease
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by The New York Memory Services.
Trial summary
The investigators reviewed 12 years of clinical use in an outpatient neurology setting of transcranial magnetic stimulation (TMS) in patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI) to evaluate safety and efficacy of TMS. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2008to 30 May 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Alzheimer disease or mild cognitive impairment.
Who may be able to join
- Patients meeting the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) criteria for possible or probable Alzheimer's disease.
- Patients meeting the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) criteria for mild cognitive impairment.
- Patients must have undergone at least two standardized neurocognitive batteries before and after beginning TMS.
- Patients must have received greater than or equal to five (5) TMS sessions in less than one year.
Who cannot join
- Patients with dementias from other causes, such as Lewy Body disease.
About this study
Official title: Transcranial Magnetic Stimulation (TMS) in Patients With Mild Cognitive Impairment (MCI) and Alzheimer Disease (AD): A Twelve-year Retrospective Observational Study
The investigators reviewed 12 years of clinical use in an outpatient neurology setting of transcranial magnetic stimulation (TMS) in patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI) to evaluate safety and efficacy of TMS.
Read the detailed description
The investigators compiled demographic, clinical, and neurocognitive data on all patients who had received TMS for any reason in the clinic over a 12-year period. Of 236 patients receiving TMS, 59 patients with AD and 14 with MCI satisfied study criteria and were compared to controls from the National Alzheimer's Coordinating Center (NACC). Neurocognitive outcomes were compared between magnetic resonance imaging (MRI) and electroencephalogram (EEG)-grid guided TMS in patients. Tolerability data was reviewed for all patients.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- TMS, Transcranial Magnetic Stimulation
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called TMS
Magnetic stimulation to alter neural activity
| Study group | Role | What they receive |
|---|---|---|
| EEG-grid-guided-TMS | Patients with Alzheimer disease and mild cognitive impairment receiving TMS using electroencephalogram grid guided navigation Receives: Device: Transcranial Magnetic Stimulation | |
| MRI-guided-TMS | Patients with Alzheimer disease and mild cognitive impairment receiving TMS using MRI guided navigation Receives: Device: Transcranial Magnetic Stimulation | |
| NACC controls | National Alzheimer's Coordinating Center matched controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Controlled Oral Word Association Test
Animal score and percentile
Measured: 05/01/2008-05/30/2020
Boston 30-item naming test
spontaneous correct (without cues)
Measured: 05/01/2008-05/30/2020
Boston 30-item naming test
total correct (with cues)
Measured: 05/01/2008-05/30/2020
Wechsler Adult Intelligence Scale III
Digit span
Measured: 05/01/2008-05/30/2020
Wechsler Adult Intelligence Scale III
verbal quotient score and percentile
Measured: 05/01/2008-05/30/2020
Wechsler Adult Intelligence Scale III
performance quotient score and percentile
Measured: 05/01/2008-05/30/2020
Wechsler Adult Intelligence Scale III
object assembly
Measured: 05/01/2008-05/30/2020
Wechsler Memory Scale III
Immediate memory score and percentile
Measured: 05/01/2008-05/30/2020
Wechsler Memory Scale III
Auditory delayed memory score and percentile
Measured: 05/01/2008-05/30/2020
Wechsler Memory Scale III
Visual delayed memory score and percentile
Measured: 05/01/2008-05/30/2020
Buschke Selective Reminding Test, 12 item
Total recall score
Measured: 05/01/2008-05/30/2020
Buschke Selective Reminding Test, 12 item, 15 minute
Delayed recall score
Measured: 05/01/2008-05/30/2020
Rosen Drawing Test
Total score
Measured: 05/01/2008-05/30/2020
Processing speed
Total score and percentile
Measured: 05/01/2008-05/30/2020
Mini-mental status examination
Total score
Measured: 05/01/2008-05/30/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 May 2008
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New York Memory Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gayatri Devi, MD, The New York Memory Services
- Investigators
- Gayatri Devi, MD, Principal investigator, NY Memory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771845
- Sponsor's protocol ID
- 20-0812
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2021
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation (TMS) in Patients With Mild Cognitive Impairment (MCI) and Alzheimer Disease (AD): A Twelve-year Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT04771845
- Acronym / sponsor ID
- 20-0812
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- TMS, Transcranial Magnetic Stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- The New York Memory ServicesUniversity, hospital or other
- Study start
- 1 May 2008 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 25 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.
The investigators reviewed 12 years of clinical use in an outpatient neurology setting of transcranial magnetic stimulation (TMS) in patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI) to evaluate safety and efficacy of TMS.
Detailed description
The investigators compiled demographic, clinical, and neurocognitive data on all patients who had received TMS for any reason in the clinic over a 12-year period. Of 236 patients receiving TMS, 59 patients with AD and 14 with MCI satisfied study criteria and were compared to controls from the National Alzheimer's Coordinating Center (NACC). Neurocognitive outcomes were compared between magnetic resonance imaging (MRI) and electroencephalogram (EEG)-grid guided TMS in patients. Tolerability data was reviewed for all patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EEG-grid-guided-TMS | – | Device: Transcranial Magnetic StimulationPatients with Alzheimer disease and mild cognitive impairment receiving TMS using electroencephalogram grid guided navigation |
| MRI-guided-TMS | – | Device: Transcranial Magnetic StimulationPatients with Alzheimer disease and mild cognitive impairment receiving TMS using MRI guided navigation |
| NACC controls | – | –National Alzheimer's Coordinating Center matched controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Alzheimer disease or mild cognitive impairment.
Key inclusion criteria (4 listed)
- Patients meeting the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) criteria for possible or probable Alzheimer's disease.
- Patients meeting the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) criteria for mild cognitive impairment.
- Patients must have undergone at least two standardized neurocognitive batteries before and after beginning TMS.
- Patients must have received greater than or equal to five (5) TMS sessions in less than one year.
Key exclusion criteria (1 listed)
- Patients with dementias from other causes, such as Lewy Body disease.
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 |
|---|---|---|
| Transcranial Magnetic StimulationAlso: TMSMagnetic stimulation to alter neural activity | Device | EEG-grid-guided-TMS, MRI-guided-TMS |
Primary outcome
Controlled Oral Word Association Test
Time frame: 05/01/2008-05/30/2020
Animal score and percentile
Boston 30-item naming test
Time frame: 05/01/2008-05/30/2020
spontaneous correct (without cues)
Boston 30-item naming test
Time frame: 05/01/2008-05/30/2020
total correct (with cues)
Wechsler Adult Intelligence Scale III
Time frame: 05/01/2008-05/30/2020
Digit span
Wechsler Adult Intelligence Scale III
Time frame: 05/01/2008-05/30/2020
verbal quotient score and percentile
Wechsler Adult Intelligence Scale III
Time frame: 05/01/2008-05/30/2020
performance quotient score and percentile
Wechsler Adult Intelligence Scale III
Time frame: 05/01/2008-05/30/2020
object assembly
Wechsler Memory Scale III
Time frame: 05/01/2008-05/30/2020
Immediate memory score and percentile
Wechsler Memory Scale III
Time frame: 05/01/2008-05/30/2020
Auditory delayed memory score and percentile
Wechsler Memory Scale III
Time frame: 05/01/2008-05/30/2020
Visual delayed memory score and percentile
Buschke Selective Reminding Test, 12 item
Time frame: 05/01/2008-05/30/2020
Total recall score
Buschke Selective Reminding Test, 12 item, 15 minute
Time frame: 05/01/2008-05/30/2020
Delayed recall score
Rosen Drawing Test
Time frame: 05/01/2008-05/30/2020
Total score
Processing speed
Time frame: 05/01/2008-05/30/2020
Total score and percentile
Mini-mental status examination
Time frame: 05/01/2008-05/30/2020
Total score
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 25 Feb 2021.
- 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.
Gayatri Devi, MD principal investigator
NY Memory
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by The New York Memory Services.
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 1 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 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Controlled Oral Word Association Test (time frame: 05/01/2008-05/30/2020). The study lists 15 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 25 Feb 2021.