Transcranial Magnetic Stimulation and Cognitive Stimulation in Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— rTMS&MCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03906903
• Other study ID #: 05-01/02/2018
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: April 2019
• Source: Universidad Autonoma de Queretaro
• Contact: Georgina Y Roque Roque, Psychologist
• Phone: +52 4421417775
• Email: georginaroqueroque[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
Subjects will receive both active and placebo rTMS, in a crossover modality.

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

Locations

Country	Name	City	State
Mexico	Autonomous University of Queretaro	Querétaro City	Querétaro

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Queretaro

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal Cognitive Assessment (MoCA)	MoCA is a test that evaluates the presence of Mild Cognitive Impairment.	24 weeks.
Primary	Mini Mental State Examination (MMSE)	MMSE is a test that seeks the presence of Mild Cognitive Impairment	24 weeks
Primary	Attention and Memory Neuropsychological Battery (NEUROPSI)	NEUROPSI is a battery that evaluates the level of the Cognitive Impairment.	24 weeks
Secondary	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.	2 Weeks
Secondary	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).	1 week