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

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Device: rTMS with H-coil; Device: Sham rTMS stimulation with H-coil

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20132
      • Irccs San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Giancarlo Comi
• Investigators: Principal Investigator: Giancarlo Comi, MD, Irccs San Raffaele

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2010
• Primary Completion (Actual): September 8, 2014
• Study Completion (Actual): September 8, 2014

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: rTMS-AD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: data are available from the corresponding author, upon reasonable request.
• IPD Sharing Supporting Information Type: Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No