Transcranial Magnetic Stimulation and Cognitive Stimulation in Mild Cognitive Impairment (rTMS&MCI)

April 15, 2019 updated by: Dr. Julian Reyes López, Universidad Autónoma de Querétaro

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 76176
        • Recruiting
        • Autonomous University of Queretaro
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 5 Hz Stimulation
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.
Device: Repetitive Transcranial Magnetic Stimulation
Subjects will receive both active and placebo rTMS, in a crossover modality.
Other Names:
  • Transcranial Magnetic Stimulation
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.
Placebo Comparator: Placebo Stimulation
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.
Device: Repetitive Transcranial Magnetic Stimulation
Subjects will receive both active and placebo rTMS, in a crossover modality.
Other Names:
  • Transcranial Magnetic Stimulation
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Depressive symptoms evaluated by Geriatric Depression Scale (GDS - Yesavage - Brink)
Time Frame: 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.
2 Weeks
Changes in impulsive behavior evaluated by Barratt Impulsivity Scale (BIS-11)
Time Frame: 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).
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autónoma de Querétaro

Investigators

  • Study Director: Julian V Reyes López, Psychiatrist, Faculty of Medicine, Autonomous University of Queretaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2018

Primary Completion (Actual)

March 30, 2019

Study Completion (Anticipated)

August 30, 2019

Study Registration Dates

First Submitted

February 5, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-01/02/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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