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

NCT04562506 | Completed DMC

• 1 other identifier: rTMS-AD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Real rTMS stimulation

ACTIVE COMPARATOR

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

Device: rTMS with H-coil

Sham rTMS stimulation

SHAM COMPARATOR

sham high frequency H-coil stimulation

Device: Sham rTMS stimulation with H-coil

Interventions

rTMS with H-coil DEVICE

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

Real rTMS stimulation

Sham rTMS stimulation with H-coil DEVICE

Sham rTMS stimulation

Sham rTMS stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Giancarlo Comi: lead

Study Sites (1)

IRCCS San Raffaele

Milan, MI, 20132, Italy

Location

Related Publications (1)

• 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.

  PMID: 33679572 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Giancarlo Comi, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: October 21, 2010
• Primary Completion: September 8, 2014
• Study Completion: September 8, 2014
• Last Updated: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: data are available from the corresponding author, upon reasonable request.

Locations

IT (1)