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

Universidad Autonoma de Queretaro

Status: Unknown

Conditions: Mild Cognitive Impairment

Treatments: Device: Repetitive Transcranial Magnetic Stimulation; Behavioral: Cognitive Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03906903

05-01/02/2018

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

5 Hz Stimulation

Active Comparator group

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.

Treatment:

Behavioral: Cognitive Stimulation

Device: Repetitive Transcranial Magnetic Stimulation

Placebo Stimulation

Placebo Comparator group

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.

Treatment:

Behavioral: Cognitive Stimulation

Device: Repetitive Transcranial Magnetic Stimulation