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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

rTMS with H-coil

Sham rTMS stimulation with H-coil

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

IRCCS San Raffaele

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real rTMS stimulation

Sham rTMS stimulation

Arm Description

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

sham high frequency H-coil stimulation

Outcomes

Primary Outcome Measures

Improvement at Alzheimer's Disease Assessment Scale-cognitive over time

Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia

Secondary Outcome Measures

Improvement at Mini Mental State Examination scale over time

Neuropsychological test used to assess the intellectual efficiency disorders and the presence of cognitive impairment

Improvement at Beck Depression Inventory scale-II over time

Self-report inventory, psychometric test used to assess the severity of depression

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

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

Full Information

NCT ID

NCT04562506

First Posted

September 18, 2020

Last Updated

September 23, 2020

Sponsor

Giancarlo Comi

1. Study Identification

Unique Protocol Identification Number

NCT04562506

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

October 21, 2010 (Actual)

Primary Completion Date

September 8, 2014 (Actual)

Study Completion Date

September 8, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Giancarlo Comi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Real rTMS stimulation

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sham rTMS stimulation

Arm Type

Sham Comparator

Arm Description

sham high frequency H-coil stimulation

Intervention Type

Device

Intervention Name(s)

rTMS with H-coil

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Sham rTMS stimulation with H-coil

Intervention Description

Sham rTMS stimulation

Primary Outcome Measure Information:

Title

Improvement at Alzheimer's Disease Assessment Scale-cognitive over time

Description

Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia

Time Frame

Change in the score between Baseline evaluation and end of the treatment (2 months after start of the treatment)

Secondary Outcome Measure Information:

Title

Improvement at Mini Mental State Examination scale over time

Description

Neuropsychological test used to assess the intellectual efficiency disorders and the presence of cognitive impairment

Time Frame

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)

Title

Improvement at Beck Depression Inventory scale-II over time

Description

Self-report inventory, psychometric test used to assess the severity of depression

Time Frame

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)

Title

Improvement at Clinical Global Impression-Improvement scale over time

Description

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

Time Frame

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)

Title

Persistence of improvement at Alzheimer's Disease Assessment Scale-cognitive over time

Description

Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia

Time Frame

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giancarlo Comi, MD

Organizational Affiliation

IRCCS San Raffaele

Official's Role

Principal Investigator

Facility Information:

Facility Name

IRCCS San Raffaele

City

Milan

State/Province

ZIP/Postal Code

20132

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

33679572

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.

Results Reference

derived

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

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