Transcranial Magnetic Stimulation and Cognitive Stimulation in Mild Cognitive Impairment

Not Applicable

• Conditions: Mild Cognitive Impairment

• Registration Number: NCT03906903
• Lead Sponsor: Universidad Autonoma de Queretaro

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

Study Timeline

• Study Start: 2018-03-05
• Study First Submitted: 2019-02-05
• Primary Completion: 2019-03-30
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16
• Study Completion: 2019-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in impulsive behavior evaluated by Barratt Impulsivity Scale (BIS-11)	1 week	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).
Changes in Depressive symptoms evaluated by Geriatric Depression Scale (GDS - Yesavage - Brink)	2 Weeks	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.

Trial Locations

Locations (1)

Autonomous University of Queretaro; 🇲🇽 Querétaro City, Querétaro, Mexico