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

Not Applicable

Completed

• Conditions: Alzheimer Disease
• Interventions: Device: Sham rTMS stimulation with H-coil; Device: rTMS with H-coil

• Registration Number: NCT04562506
• Lead Sponsor: Giancarlo Comi

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

Study Timeline

• Study Start: 2010-10-21
• Primary Completion: 2014-09-08
• Study Completion: 2014-09-08
• Status Verified: 2020-09
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-23
• Last Update Submitted: 2020-09-23
• Study First Posted: 2020-09-24
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham rTMS stimulation	Sham rTMS stimulation with H-coil	sham high frequency H-coil stimulation
Real rTMS stimulation	rTMS with H-coil	real deep excitatory, high frequency rTMS with H-coil stimulation

Primary Outcome Measures

Name	Time	Method
Improvement at Alzheimer's Disease Assessment Scale-cognitive over time	Change in the score between Baseline evaluation and end of the treatment (2 months after start of the treatment)	Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia

Secondary Outcome Measures

Name	Time	Method
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)	Neuropsychological test used to assess the intellectual efficiency disorders and the presence of cognitive impairment
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)	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
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)	Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia
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)	Self-report inventory, psychometric test used to assess the severity of depression

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Milan, MI, Italy