Mild Cognitive ImpairmentrTMS&MCINCT03906903
Transcranial Magnetic Stimulation and Cognitive Stimulation in Mild Cognitive Impairment
A study testing Repetitive Transcranial Magnetic Stimulation and Cognitive Stimulation in people with Mild Cognitive Impairment, run by Universidad Autonoma de Queretaro at 1 site in Mexico.
Trial summary
This study evaluates the effect of 5Hertz (Hz) repetitive Transcranial Magnetic Stimulation (rTMS) on Left Dorsolateral Prefrontal Cortex enhancing Cognitive Stimulation in Mild Cognitive Impairment. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation and Cognitive Stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 5 Mar 2018to 30 Aug 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of both genders.
- Subjects from 60 to 85 years old.
- Meet Diagnostic and Statistical Manual, 5th edition (DSM-5) diagnostic criteria for Mild Cognitive Impairment.
- Patients must provide their oral and written informed consent.
Who cannot join
- Subjects with history of traumatic brain injury with loss of consciousness.
- Subjects with intracranial metallic objects or metal plates in the skull.
- Subjects diagnosed with uncontrolled chronic (for example: hypertension, diabetes) or neurological diseases.
- Comorbidity with other mental illness.
- Presence of psychotic symptoms, Bipolar Disorder and Substance abuse.
- Alterations in the electroencephalogram (epileptiform activity).
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Autonomous University of Queretaro
Querétaro City, Querétaro, 76176
Georgina Y. Roque Roque, Psychologist, +52 4421417775, georginaroqueroque@gmail.com
About this study
Official title: Effect of Transcranial Magnetic Stimulation as an Enhancer of a Cognitive Stimulation Maneuver in Mild Cognitive Impairment
This study evaluates the effect of 5Hertz (Hz) repetitive Transcranial Magnetic Stimulation (rTMS) on Left Dorsolateral Prefrontal Cortex enhancing Cognitive Stimulation in Mild Cognitive Impairment.
Read the detailed description
Mild Cognitive Impairment (MCI) is defined as an intermediate state between normal aging and an early stage of neurodegenerative diseases. It is estimated that exist 24.3 million people worldwide with neurocognitive disorders. Cognitive Stimulation (CS) is defined as the set of techniques and strategies that optimize the effectiveness in various functions of different cognitive abilities throughout its use in rehabilitation on MCI. Transcranial Magnetic Stimulation (rTMS) is a safe neuromodulation technique that modifies brain electrical activity through electromagnetic fields. There is evidence of the relationship between CS and rTMS for the improvement in MCI levels and cognitive functions; it´s important to deepen the knowledge of the therapeutic potential of both techniques combined on MCI
- Conditions
- Mild Cognitive Impairment
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Cognitive Stimulation
- Keywords
- Mild Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Also called Transcranial Magnetic Stimulation
Subjects will receive both active and placebo rTMS, in a crossover modality.
Cognitive StimulationBehavioural
Subjects will receive 30 sessions of 30 minutes with Cognitive Stimulation in three areas (attention, memory and executive functions), one each week.
| Study group | Role | What they receive |
|---|---|---|
| 5 Hz Stimulation | Active comparator | This group will receive 5Hz (Hertz) Left Dorsolateral Prefrontal Cortex repetitive Transcranial Magnetic Stimulation with 1500 pulses per session, three per weekday, with a final result of 30 sessions in this modality with a 30 minutes Cognitive Stimulation after session. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Behavioral: Cognitive Stimulation |
| Placebo Stimulation | Placebo comparator | This group will receive the Sham modality simulating 1500 pulses of 5Hz Transcranial Magnetic Stimulation for 30 sessions, three per weekday with a 30 minutes Cognitive Stimulation afterwards. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Behavioral: Cognitive Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
MoCA is a test that evaluates the presence of Mild Cognitive Impairment.
Measured: 24 weeks.
Mini Mental State Examination (MMSE)
MMSE is a test that seeks the presence of Mild Cognitive Impairment
Measured: 24 weeks
Attention and Memory Neuropsychological Battery (NEUROPSI)
NEUROPSI is a battery that evaluates the level of the Cognitive Impairment.
Measured: 24 weeks
Secondary outcomes (2)
Changes in Depressive symptoms evaluated by Geriatric Depression Scale (GDS - Yesavage - Brink)
The Geriatric Depression Scale is a 30 item scale that evaluates the severity of depressive symptoms in Geriatric patients. With a minimum of 0 and a maximum of 30 scores, above 11 are suggestive for depression, relating a higher score with a higher depression level.
Measured: 2 Weeks
Changes in impulsive behavior evaluated by Barratt Impulsivity Scale (BIS-11)
The Barratt Impulsivity Scale is a likert-type self-questionnaire designed to assess the personality and behavioral construct of impulsiveness; composed of 30 items, each one scored from 0-4 according to the presence and severity of them, describing common impulsive or non-impulsive behaviors and preferences. This scale does not have a cut-off point, relating a higher score with a higher impulsivity in which can be assessed three types of impulsivity (cognitive, motor and non-planned impulsivity).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start5 Mar 2018
- Primary completion30 Mar 2019
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The aim of this study is to evaluate the clinical effects of 5Hz rTMS over Left Dorsolateral Prefrontal Cortex on an active versus placebo modality stimulation and Cognitive Stimulation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Julian Reyes López, Universidad Autonoma de Queretaro
- Investigators
- Julian V Reyes López, Psychiatrist, Study director, Faculty of Medicine, Autonomous University of Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906903
- Sponsor's protocol ID
- 05-01/02/2018
- Acronym
- rTMS&MCI
- Status last verified
- Apr 2019
- First submitted
- 5 Feb 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Magnetic Stimulation as an Enhancer of a Cognitive Stimulation Maneuver in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03906903
- Acronym / sponsor ID
- rTMS&MCI / 05-01/02/2018
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidad Autonoma de QueretaroUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 8 Apr 2019 (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 study evaluates the effect of 5Hertz (Hz) repetitive Transcranial Magnetic Stimulation (rTMS) on Left Dorsolateral Prefrontal Cortex enhancing Cognitive Stimulation in Mild Cognitive Impairment.
Detailed description
Mild Cognitive Impairment (MCI) is defined as an intermediate state between normal aging and an early stage of neurodegenerative diseases. It is estimated that exist 24.3 million people worldwide with neurocognitive disorders. Cognitive Stimulation (CS) is defined as the set of techniques and strategies that optimize the effectiveness in various functions of different cognitive abilities throughout its use in rehabilitation on MCI. Transcranial Magnetic Stimulation (rTMS) is a safe neuromodulation technique that modifies brain electrical activity through electromagnetic fields. There is evidence of the relationship between CS and rTMS for the improvement in MCI levels and cognitive functions; it´s important to deepen the knowledge of the therapeutic potential of both techniques combined on MCI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The aim of this study is to evaluate the clinical effects of 5Hz rTMS over Left Dorsolateral Prefrontal Cortex on an active versus placebo modality stimulation and Cognitive Stimulation.
| Arm | Type | Receives |
|---|---|---|
| 5 Hz Stimulation | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation, Behavioral: Cognitive StimulationThis group will receive 5Hz (Hertz) Left Dorsolateral Prefrontal Cortex repetitive Transcranial Magnetic Stimulation with 1500 pulses per session, three per weekday, with a final result of 30 sessions in this modality with a 30 minutes Cognitive Stimulation after session. |
| Placebo Stimulation | Placebo comparator | Device: Repetitive Transcranial Magnetic Stimulation, Behavioral: Cognitive StimulationThis group will receive the Sham modality simulating 1500 pulses of 5Hz Transcranial Magnetic Stimulation for 30 sessions, three per weekday with a 30 minutes Cognitive Stimulation afterwards. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects of both genders.
- Subjects from 60 to 85 years old.
- Meet Diagnostic and Statistical Manual, 5th edition (DSM-5) diagnostic criteria for Mild Cognitive Impairment.
- Patients must provide their oral and written informed consent.
Key exclusion criteria (6 listed)
- Subjects with history of traumatic brain injury with loss of consciousness.
- Subjects with intracranial metallic objects or metal plates in the skull.
- Subjects diagnosed with uncontrolled chronic (for example: hypertension, diabetes) or neurological diseases.
- Comorbidity with other mental illness.
- Presence of psychotic symptoms, Bipolar Disorder and Substance abuse.
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 |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationAlso: Transcranial Magnetic StimulationSubjects will receive both active and placebo rTMS, in a crossover modality. | Device | 5 Hz Stimulation, Placebo Stimulation |
| Cognitive StimulationSubjects will receive 30 sessions of 30 minutes with Cognitive Stimulation in three areas (attention, memory and executive functions), one each week. | Behavioural | 5 Hz Stimulation, Placebo Stimulation |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: 24 weeks.
MoCA is a test that evaluates the presence of Mild Cognitive Impairment.
Mini Mental State Examination (MMSE)
Time frame: 24 weeks
MMSE is a test that seeks the presence of Mild Cognitive Impairment
Attention and Memory Neuropsychological Battery (NEUROPSI)
Time frame: 24 weeks
NEUROPSI is a battery that evaluates the level of the Cognitive Impairment.
2 secondary outcomes
Changes in Depressive symptoms evaluated by Geriatric Depression Scale (GDS - Yesavage - Brink)
Time frame: 2 Weeks
Changes in impulsive behavior evaluated by Barratt Impulsivity Scale (BIS-11)
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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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.
Julian V Reyes López, Psychiatrist study director
Faculty of Medicine, Autonomous University of Queretaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation and Cognitive Stimulation in people with Mild Cognitive Impairment, run by Universidad Autonoma de Queretaro 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 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: status not confirmed, as of the sponsor's last update on 16 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgina Y Roque Roque, Psychologist (+52 4421417775, georginaroqueroque@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: 24 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?
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 16 Apr 2019.