Alzheimer Disease
Conditions
Brief summary
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
Study Design The study was a double-blind, placebo-controlled paradigm, with randomization into a real rTMS group or a sham rTMS
Interventions
DEVICErTMS with H-coil
Deep repetitive transcranial manetic stimulation or sham stimulation with H-coil
DEVICESham rTMS stimulation with H-coil
Sham rTMS stimulation
Sponsors
Giancarlo Comi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement at Alzheimer's Disease Assessment Scale-cognitive over time | Change in the score between Baseline evaluation and end of the treatment (2 months after start of the treatment) | Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement at Mini Mental State Examination scale over time | 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) | Neuropsychological test used to assess the intellectual efficiency disorders and the presence of cognitive impairment |
| Improvement at Beck Depression Inventory scale-II over time | 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) | Self-report inventory, psychometric test used to assess the severity of depression |
| Improvement at Clinical Global Impression-Improvement scale over time | 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) | 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 |
| Persistence of improvement at Alzheimer's Disease Assessment Scale-cognitive over time | 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) | Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia |
Countries
Italy
Outcome results
None listed