Repetitive Transcranial Magnetic Stimulation With H-coil in Alzheimer's Disease

Giancarlo Comi30 enrolled

Overview

Focal repetitive transcranial magnetic stimulation (rTMS) has been applied to improve cognition in Alzheimer's disease (AD) with conflicting results. In this study we aimed to explore feasibility, safety and efficacy of excitatory rTMS of bilateral DLPFC applied with H-coil in AD in a pilot randomized, placebo-controlled, double-blind study.

Study Design The study was a double-blind, placebo-controlled paradigm, with randomization into a real rTMS group or a sham rTMS

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Alzheimer Disease

Interventions

rTMS with H-coilDEVICE

Deep repetitive transcranial manetic stimulation or sham stimulation with H-coil

Sham rTMS stimulation with H-coilDEVICE

Sham rTMS stimulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ability to understand the purpose and risk of the study and provide signed and dated informed consent. * Male or female subjects, 18 to 80 years old. * Diagnosis of Alzheimer's disease according to the DSM IV * Subjects who answered all questions in the TMS pre-treatment safety questionnaire in a negative manner. * Have given written informed consent Exclusion Criteria: * Presence of an additional neurological or psychiatric pathology. * Severe personality disorder. * Uncontrolled hypertension. * History of epilepsy, seizures, febrile convulsions. * History of epilepsy or seizures in first degree relatives. * History of head injury or stroke. * Presence of metal prostheses in the head (except dental fillings). * Metal implants or known history of any metal particles in the eye, cardiac pacemakers, cochlear implants, use of neurostimulators or medical pumps. * History of migraine within the past six months. * History of drug or alcohol abuse. * Impossibility of adequate communication with the examiner. * Participation in another clinical study, either concomitant or within the previous 3 months. * Inability to sign the consent form.

Locations (1)

IRCCS San Raffaele

Milan, MI, Italy

Outcomes

Primary Outcomes

Improvement at Alzheimer's Disease Assessment Scale-cognitive over time

Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia

Time frame: Change in the score between Baseline evaluation and end of the treatment (2 months after start of the treatment)

Secondary Outcomes

Improvement at Mini Mental State Examination scale over time

Neuropsychological test used to assess the intellectual efficiency disorders and the presence of cognitive impairment

Time frame: Baseline evaluation, 1 month after start of the treatment, end of the treatment (2 months after start of the treatment) and end of follow-up (4 months after start of the treatment)

Improvement at Beck Depression Inventory scale-II over time

Self-report inventory, psychometric test used to assess the severity of depression

Time frame: Baseline evaluation, 1 month after start of the treatment, end of the treatment (2 months after start of the treatment) and end of follow-up (4 months after start of the treatment)

Improvement at Clinical Global Impression-Improvement scale over time

Scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention

Time frame: Baseline evaluation, 1 month after start of the treatment, end of the treatment (2 months after start of the treatment) and end of follow-up (4 months after start of the treatment)

Persistence of improvement at Alzheimer's Disease Assessment Scale-cognitive over time

Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia

Time frame: Change in the score between end of treatment (2 months after start of the treatment) and end of follow-up (4 months after start of treatment)

Data from ClinicalTrials.gov

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