Clinical trial NCT04562506: Repetitive Transcranial Magnetic Stimulation With H-coil in Alzheimer's Disease
Official title: Repetitive Transcranial Magnetic Stimulation With H-coil in Alzheimer's Disease: A Double-blind, Placebo-controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement at Alzheimer's Disease Assessment Scale-cognitive over time
timeFrame: Change in the score between Baseline evaluation and end of the treatment (2 months after start of the treatment)
Secondary outcomes:
measure: Improvement at Mini Mental State Examination scale over time
timeFrame: 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)
measure: Improvement at Beck Depression Inventory scale-II over time
timeFrame: 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)
measure: Improvement at Clinical Global Impression-Improvement scale over time
timeFrame: 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)
measure: Persistence of improvement at Alzheimer's Disease Assessment Scale-cognitive over time
timeFrame: 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)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
state: MI
Study officials:
affiliation: IRCCS San Raffaele
name: Giancarlo Comi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leocani L, Dalla Costa G, Coppi E, Santangelo R, Pisa M, Ferrari L, Bernasconi MP, Falautano M, Zangen A, Magnani G, Comi G. Repetitive Transcranial Magnetic Stimulation With H-Coil in Alzheimer's Disease: A Double-Blind, Placebo-Controlled Pilot Study. Front Neurol. 2021 Feb 18;11:614351. doi: 10.3389/fneur.2020.614351. eCollection 2020.