Transcranial Magnetic Stimulation and Cognitive Stimulation in Mild Cognitive Impairment

NCT ID: NCT03906903

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2019-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

Cognitive Stimulation

Intervention Type BEHAVIORAL

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

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.

Group Type PLACEBO_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

Cognitive Stimulation

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Repetitive Transcranial Magnetic Stimulation

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

Intervention Type DEVICE

Cognitive Stimulation

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Transcranial Magnetic Stimulation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Autonoma de Queretaro

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Julian Reyes López

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julian V Reyes López, Psychiatrist

Role: STUDY_DIRECTOR

Faculty of Medicine, Autonomous University of Queretaro

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Autonomous University of Queretaro

Querétaro City, Querétaro, Mexico

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Georgina Y Roque Roque, Psychologist

Role: CONTACT

+52 4421417775

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Georgina Y. Roque Roque, Psychologist

Role: primary

+52 4421417775

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

05-01/02/2018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

rTMS to Improve Cognition in Parkinson's
NCT03836950 RECRUITING PHASE1/PHASE2