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

Giancarlo Comi

Status: Completed

Conditions: Alzheimer Disease

Treatments: Device: rTMS with H-coil; Device: Sham rTMS stimulation with H-coil

Study type: Interventional

Funder types: Other

Identifiers

NCT04562506

rTMS-AD

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Real rTMS stimulation

Active Comparator group

Description:

real deep excitatory, high frequency rTMS with H-coil stimulation

Treatment:

Device: rTMS with H-coil

Sham rTMS stimulation

Sham Comparator group

Description:

sham high frequency H-coil stimulation

Treatment:

Device: Sham rTMS stimulation with H-coil