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

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Cognitive Stimulation
Sponsored by
Universidad Autonoma de Queretaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Autonomous University of QueretaroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

5 Hz Stimulation

Placebo Stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).

Full Information

First Posted
February 5, 2019
Last Updated
April 15, 2019
Sponsor
Universidad Autonoma de Queretaro
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1. Study Identification

Unique Protocol Identification Number
NCT03906903
Brief Title
Transcranial Magnetic Stimulation and Cognitive Stimulation in Mild Cognitive Impairment
Acronym
rTMS&MCI
Official Title
Effect of Transcranial Magnetic Stimulation as an Enhancer of a Cognitive Stimulation Maneuver in Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Queretaro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Masking Description
Single
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5 Hz Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Stimulation
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Other Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
Subjects will receive both active and placebo rTMS, in a crossover modality.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Stimulation
Intervention Description
Subjects will receive 30 sessions of 30 minutes with Cognitive Stimulation in three areas (attention, memory and executive functions), one each week.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA)
Description
MoCA is a test that evaluates the presence of Mild Cognitive Impairment.
Time Frame
24 weeks.
Title
Mini Mental State Examination (MMSE)
Description
MMSE is a test that seeks the presence of Mild Cognitive Impairment
Time Frame
24 weeks
Title
Attention and Memory Neuropsychological Battery (NEUROPSI)
Description
NEUROPSI is a battery that evaluates the level of the Cognitive Impairment.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Changes in Depressive symptoms evaluated by Geriatric Depression Scale (GDS - Yesavage - Brink)
Description
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.
Time Frame
2 Weeks
Title
Changes in impulsive behavior evaluated by Barratt Impulsivity Scale (BIS-11)
Description
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).
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georgina Y Roque Roque, Psychologist
Phone
+52 4421417775
Email
georginaroqueroque@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian V Reyes López, Psychiatrist
Organizational Affiliation
Faculty of Medicine, Autonomous University of Queretaro
Official's Role
Study Director
Facility Information:
Facility Name
Autonomous University of Queretaro
City
Querétaro City
State/Province
Querétaro
ZIP/Postal Code
76176
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgina Y. Roque Roque, Psychologist
Phone
+52 4421417775
Email
georginaroqueroque@gmail.com

12. IPD Sharing Statement

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Transcranial Magnetic Stimulation and Cognitive Stimulation in Mild Cognitive Impairment

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