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
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
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.
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
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
MI
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
Learn more about this trial
Repetitive Transcranial Magnetic Stimulation With H-coil in Alzheimer's Disease
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