NCT03906903

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

February 5, 2019

Last Update Submit

April 15, 2019

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

  • Montreal Cognitive Assessment (MoCA)

    MoCA is a test that evaluates the presence of Mild Cognitive Impairment.

    24 weeks.

  • Mini Mental State Examination (MMSE)

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

    24 weeks

  • Attention and Memory Neuropsychological Battery (NEUROPSI)

    NEUROPSI is a battery that evaluates the level of the Cognitive Impairment.

    24 weeks

Secondary Outcomes (2)

  • Changes in Depressive symptoms evaluated by Geriatric Depression Scale (GDS - Yesavage - Brink)

    2 Weeks

  • Changes in impulsive behavior evaluated by Barratt Impulsivity Scale (BIS-11)

    1 week

Study Arms (2)

5 Hz Stimulation

ACTIVE COMPARATOR

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 StimulationBehavioral: Cognitive Stimulation

Placebo Stimulation

PLACEBO COMPARATOR

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 StimulationBehavioral: Cognitive Stimulation

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

Subjects will receive both active and placebo rTMS, in a crossover modality.

Also known as: Transcranial Magnetic Stimulation
5 Hz StimulationPlacebo Stimulation
Cognitive StimulationBEHAVIORAL

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

5 Hz StimulationPlacebo Stimulation

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Autonomous University of Queretaro

Querétaro City, Querétaro, 76176, Mexico

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Julian V Reyes López, Psychiatrist

    Faculty of Medicine, Autonomous University of Queretaro

    STUDY DIRECTOR

Central Study Contacts

Georgina Y Roque Roque, Psychologist

CONTACT

+52 4421417775georginaroqueroque@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 5, 2019

First Posted

April 8, 2019

Study Start

March 5, 2018

Primary Completion

March 30, 2019

Study Completion

August 30, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

ME(1)