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Mild Cognitive ImpairmentNCT03983655

Effect of High Frequency/Low Intensity Transcranial Magnetic Stimulation in Cognitive Traits of an Elderly Population of Subjects With Mild Cognitive Impairment and Mild Dementia.

A study testing High Frequency Low Intensity TMS in people with Mild Cognitive Impairment and Mild Dementia, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

There are no pharmacological interventions that delay or prevent the transition of mild cognitive impairment to dementia. Several studies have shown that transcranial magnetic stimulation (TMS) could be useful in increasing cognitive traits in dementia. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Mild Cognitive Impairment, Mild Dementia
What is being tested?
High Frequency Low Intensity TMS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
1 siteMexico
Study dates
17 May 2019to 1 Aug 2020
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

None listed.

Who cannot join

  • ( - ) Other neurodegenerative disorder different than mild cognitive impairment or mild dementia ( - ) Metabolic disease without medical care ( - ) Epilepsy ( - ) Deep brain stimulator ( - ) Metalic prosthethics in the skulls ( - ) Major depressive disorder ( - ) Previous utilization of other neuromodulation technique ( - ) Signs or symptoms of increased intracraneal pressure

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080

Other trials in Mexico

About this study

Official title: Effect of High Frequency/Low Intensity Transcranial Magnetic Stimulation in Cognitive Traits of an Elderly Population of Subjects With Mild Cognitive Impairment and Mild Dementia: A Randomized, Double Blind, Parallel Group, Sham Controlled Clinical Trial

There are no pharmacological interventions that delay or prevent the transition of mild cognitive impairment to dementia. Several studies have shown that transcranial magnetic stimulation (TMS) could be useful in increasing cognitive traits in dementia.

As TMS is performed in a clinical setting, transportation, mobility and high costs of treatment, limit the number of TMS sessions dementia patients can receive. Most of the trials do not apply more than 20 TMS sessions

Here, a randomized, sham controlled, paralallel group, clinical trial will be performed in order to asess the efficacy at improving cognitive traits of a novel TMS device that uses high frequency and low intensity pulses. As the device is portable and can be used from home without clinical supervision, the stimulation will be applied two times per day for a period of 6 months.

Being tested
High Frequency Low Intensity TMS
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Frequency Low Intensity TMSDevice

    125 hz, 10 gauss, 2 times daily for 6 monts

Study groups in NCT03983655
Study groupRoleWhat they receive
Real High Frequency Low Intensity TMSExperimentalTwo sessions of transcranial magnetic stimulation each day for 6 monts. The coil of the device emits a pulsed magnetic field at an aproximate frequency of 125 hz and an intensity of 10 gauss.
Receives: Device: High Frequency Low Intensity TMS
Sham High Frequency Low Intensity TMSSham comparatorTwo sessions of transcranial magnetic stimulation each day for 6 monts. The coil of the device does not emit a magnetic field.
Receives: Device: High Frequency Low Intensity TMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients suffering any kind of adverse effect

    Measured: 6 months

Secondary outcomes (11)

  1. Change from baseline of total Katz Index of Independence in Activities of Daily Living at 3 months

    Measured: 3 months

  2. Change from baseline of total Katz Index of Independence in Activities of Daily Living at 6 months

    Measured: 6 months

  3. Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 3 months

    Measured: 3 months

  4. Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 6 months

    Measured: 6 months

  5. Change from baseline of total Geriatric Depression Scale at 3 months

    Measured: 3 months

  6. Change from baseline of total Geriatric Depression Scale at 6 months

    Measured: 6 months

  7. Change from baseline of total Montreal Cognitive Assessment at 3 months

    Measured: 3 months

  8. Change from baseline of total Montreal Cognitive Assessment at 6 monts

    Measured: 6 months

  9. Change from baseline of total Frontal Asessment Battery at 3 monts

    Measured: 3 months

  10. Change from baseline Frontal Asessment Battery at 6 monts

    Measured: 6 months

  11. Change from baseline ADAS-COG at 6 monts

    Alzheimer´s Disease Assessment Scale-Cognitive

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2019
  2. Study start17 May 2019
  3. Primary completion17 May 2020
  4. Study completion1 Aug 2020

Why it stopped: COVID-19 pandemic

Resources

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
Device feasibility
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03983655
Sponsor's protocol ID
GER-2962-19-20-1
Status last verified
Aug 2021
First submitted
21 May 2019
Last updated
12 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mimenza-Alvarado AJ, Aguilar-Navarro SG, Martinez-Carrillo FM, Rios-Ponce AE, Villafuerte G. Use of Fast Gamma Magnetic Stimulation Over the Left Prefrontal Dorsolateral Cortex for the Treatment of MCI and Mild Alzheimer's Disease: A Double-Blind, Randomized, Sham-Controlled, Pilot Study. Front Neurol. 2021 Sep 9;12:729872. doi: 10.3389/fneur.2021.729872. eCollection 2021.

    PubMed 34566873

Questions about this trial

What is this clinical trial studying?

A study testing High Frequency Low Intensity TMS in people with Mild Cognitive Impairment and Mild Dementia, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

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 0 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: stopped early, as of the sponsor's last update on 12 Aug 2021. 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 Mexico. 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 was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.

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?

Proportion of patients suffering any kind of adverse effect (time frame: 6 months). 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 NCT03983655, 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 Aug 2021.

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