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Transcranial Magnetic Stimulation and Cognitive Stimulation in Mild Cognitive Impairment

Effect of Transcranial Magnetic Stimulation as an Enhancer of a Cognitive Stimulation Maneuver in Mild Cognitive Impairment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03906903
Acronym
rTMS&MCI
Enrollment
20
Registered
2019-04-08
Start date
2018-03-05
Completion date
2019-08-30
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment

Brief 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.

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

Interventions

DEVICERepetitive Transcranial Magnetic Stimulation

Subjects will receive both active and placebo rTMS, in a crossover modality.

BEHAVIORALCognitive Stimulation

Subjects will receive 30 sessions of 30 minutes with Cognitive Stimulation in three areas (attention, memory and executive functions), one each week.

Sponsors

Universidad Autonoma de Queretaro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Single

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Montreal Cognitive Assessment (MoCA)24 weeks.MoCA is a test that evaluates the presence of Mild Cognitive Impairment.
Mini Mental State Examination (MMSE)24 weeksMMSE is a test that seeks the presence of Mild Cognitive Impairment
Attention and Memory Neuropsychological Battery (NEUROPSI)24 weeksNEUROPSI is a battery that evaluates the level of the Cognitive Impairment.

Secondary

MeasureTime frameDescription
Changes in Depressive symptoms evaluated by Geriatric Depression Scale (GDS - Yesavage - Brink)2 WeeksThe 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.
Changes in impulsive behavior evaluated by Barratt Impulsivity Scale (BIS-11)1 weekThe 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).

Countries

Mexico

Contacts

Primary ContactGeorgina Y Roque Roque, Psychologist
georginaroqueroque@gmail.com+52 4421417775

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026