Effect of Transcranial Magnetic Stimulation as an Enhancer of a Cognitive Stimulation Maneuver in Mild Cognitive Impairment
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Montreal Cognitive Assessment (MoCA)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Single
Eligibility Criteria
- Ages
- 60 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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.
Intervention: Repetitive Transcranial Magnetic Stimulation (Device)
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.
Intervention: Cognitive Stimulation (Behavioral)
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.
Intervention: Repetitive Transcranial Magnetic Stimulation (Device)
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.
Intervention: Cognitive Stimulation (Behavioral)
Outcomes
Primary Outcomes
Montreal Cognitive Assessment (MoCA)
Time Frame: 24 weeks.
MoCA is a test that evaluates the presence of Mild Cognitive Impairment.
Attention and Memory Neuropsychological Battery (NEUROPSI)
Time Frame: 24 weeks
NEUROPSI is a battery that evaluates the level of the Cognitive Impairment.
Mini Mental State Examination (MMSE)
Time Frame: 24 weeks
MMSE is a test that seeks the presence of Mild Cognitive Impairment
Secondary Outcomes
- Changes in impulsive behavior evaluated by Barratt Impulsivity Scale (BIS-11)(1 week)
- Changes in Depressive symptoms evaluated by Geriatric Depression Scale (GDS - Yesavage - Brink)(2 Weeks)
Investigators
Dr. Julian Reyes López
Clinical Professor
Universidad Autonoma de Queretaro