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Clinical Trials/NCT03906903
NCT03906903
Unknown
Not Applicable

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

Universidad Autonoma de Queretaro1 site in 1 country20 target enrollmentMarch 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Universidad Autonoma de Queretaro
Enrollment
20
Locations
1
Primary Endpoint
Montreal Cognitive Assessment (MoCA)
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 5, 2018
End Date
August 30, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Julian Reyes López

Clinical Professor

Universidad Autonoma de Queretaro

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Montreal Cognitive Assessment (MoCA)

Time Frame: 24 weeks.

MoCA is a test that evaluates 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.

Mini Mental State Examination (MMSE)

Time Frame: 24 weeks

MMSE is a test that seeks the presence of Mild Cognitive Impairment

Secondary Outcomes

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

Study Sites (1)

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