Clinical trial NCT03906903: Transcranial Magnetic Stimulation and Cognitive Stimulation in Mild Cognitive Impairment
Official title: Effect of Transcranial Magnetic Stimulation as an Enhancer of a Cognitive Stimulation Maneuver in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Lead sponsor: Universidad Autonoma de Queretaro
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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

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).

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 24 weeks.
measure: Mini Mental State Examination (MMSE)
timeFrame: 24 weeks
measure: Attention and Memory Neuropsychological Battery (NEUROPSI)
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes in Depressive symptoms evaluated by Geriatric Depression Scale (GDS - Yesavage - Brink)
timeFrame: 2 Weeks
measure: Changes in impulsive behavior evaluated by Barratt Impulsivity Scale (BIS-11)
timeFrame: 1 week
Other outcomes:
Locations:
city: Querétaro City
country: Mexico
facility: Autonomous University of Queretaro
state: Querétaro
Study officials:
affiliation: Faculty of Medicine, Autonomous University of Queretaro
name: Julian V Reyes López, Psychiatrist
role: STUDY_DIRECTOR
References: