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

Study Overview
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Brief Summary
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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.

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

Official Title
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Repetitive Transcranial Magnetic Stimulation With H-coil in Alzheimer's Disease: A Double-blind, Placebo-controlled Pilot Study

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Device: rTMS with H-coil
* Device: Sham rTMS stimulation with H-coil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real rTMS stimulation<br>real deep excitatory, high frequency rTMS with H-coil stimulation | Device: rTMS with H-coil<br>* Deep repetitive transcranial manetic stimulation or sham stimulation with H-coil<br>|
| Sham Comparator: Sham rTMS stimulation<br>sham high frequency H-coil stimulation | Device: Sham rTMS stimulation with H-coil<br>* Sham rTMS stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement at Alzheimer's Disease Assessment Scale-cognitive over time | Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia | Change in the score between Baseline evaluation and end of the treatment (2 months after start of the treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement at Mini Mental State Examination scale over time | Neuropsychological test used to assess the intellectual efficiency disorders and the presence of cognitive impairment | 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 | 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 | 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 | 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) |