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

NCT ID: NCT04562506

Last Updated: 2020-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-21
• Study Completion Date: 2014-09-08

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

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Real rTMS stimulation

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

Group Type: ACTIVE_COMPARATOR

rTMS with H-coil

Intervention Type: DEVICE

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

Sham rTMS stimulation

sham high frequency H-coil stimulation

Group Type: SHAM_COMPARATOR

Sham rTMS stimulation with H-coil

Intervention Type: DEVICE

Sham rTMS stimulation

Interventions

rTMS with H-coil

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

Intervention Type: DEVICE

Sham rTMS stimulation with H-coil

Sham rTMS stimulation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Giancarlo Comi

OTHER

Sponsor Role: lead

Responsible Party

Giancarlo Comi

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Giancarlo Comi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele

Locations

IRCCS San Raffaele

Milan, MI, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 33679572 (View on PubMed)

Other Identifiers

rTMS-AD

Identifier Type: -

Identifier Source: org_study_id